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Adolescents and Young Adults (AYAs) With Advanced Cancer

Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05593016
Enrollment
75
Registered
2022-10-25
Start date
2023-01-17
Completion date
2024-08-01
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent and Young Adult Cancer Patient

Brief summary

This study aims to develop and test the feasibility and acceptability of a psychosocial symptom management intervention designed to meet the unique needs of Adolescents and Young Adults (AYAs) with advanced cancer. The proposed intervention will combine traditional behavioral symptom management strategies commonly use in the palliative care setting with important skills and concepts from Meaning-Centered Psychotherapy and Acceptance and Commitment Therapy. Skills from these approaches may be particularly relevant to AYAs with advanced cancer who experience significant disruption in life goals from cancer and associated symptoms and may have greater difficulties understanding and finding meaning in their lives than older and younger patients. Intervention content, structure, and study procedures will be informed by qualitative data obtained during interviews/focus groups with patient (n=16) and caregiver (n=12) stakeholders as well as review by patient user testers (n=3). It is anticipated that the intervention will include four weekly sessions spaced over 6-8 weeks and be delivered using videoconferencing. Next, AYAs with advanced cancer (N=40) will be randomized to the intervention or education control arms using an allocation ratio of 1.5: 1. The study team will examine the feasibility of study recruitment and retention, acceptability, and changes in variables of interest (i.e., physical and psychological symptoms, symptom interference, self-efficacy for symptom management, experiential avoidance, values) over time for the intervention and control arms. Participants will also provide feedback on study materials, intervention format, and the appropriateness of the intervention to the population and advanced stage of disease.

Detailed description

The investigators propose to begin to fill this gap by developing and pilot testing a psychosocial symptom management intervention designed to meet the unique needs of AYAs with advanced cancer. Guided by the team's prior work developing symptom management interventions for older advanced cancer patients and expertise in AYA Oncology, the proposed intervention will combine traditional behavioral symptom management strategies (e.g., activity pacing, relaxation training) commonly used in palliative care with important skills and concepts from Meaning-Centered Psychotherapy (MCP) and Acceptance and Commitment Therapy (ACT). Both MCP and ACT have been associated with decreased distress and symptom burden in oncology patients with advanced cancer. The study team anticipates that the intervention will incorporate questions from MCP to help patients identify valued life areas impacted by symptoms; techniques from ACT will then be used to help patients obtain distance from psychological barriers (e.g., thoughts, emotional experiences) to enacting their values to allow for flexible, value-congruent behaviors. Skills from these approaches may be particularly relevant to AYAs with advanced cancer who experience significant disruption in life goals due to symptoms and may have greater difficulty understanding and finding meaning in their lives. Aim 1: Intervention Development. Preliminary intervention content has been outlined and will be further informed by interviews with patients (AYAs with advanced cancer, aged 15-29; two groups, n=12), caregivers (one group, n=8), and a combined patient/caregiver group (one group; AYAs: n=4; caregivers: n=4) who will provide information about the symptom (e.g., pain, fatigue, emotional distress) experience of AYAs with advanced cancer, patients' symptom management needs and coping strategies, the unique developmental aspects of being an AYA or caring for an AYA with advanced cancer, and how patient and caregiver needs may interact to impact symptom management. Participant input will help to confirm whether the proposed intervention strategies (i.e., behavioral symptom management, ACT, MCP) may be of benefit for addressing the unique needs of AYAs with advanced cancer. User testing of the developed intervention will be conducted with an additional three AYAs with advanced cancer to further refine the intervention content and format, written study materials, and study procedures. Aim 2: Pilot Randomized Controlled Trial. AYAs with advanced cancer (N=40) will be randomized to the intervention or an education control arm using an allocation ratio of 1.5:1. Feasibility of study recruitment (N=40 in 12 months) and participant retention (\>80% intervention completion) will be examined along with intervention acceptability. Patterns of change in symptom (i.e., pain, fatigue, distress) severity and interference, self-efficacy for symptom management, and targets of ACT and MCP (e.g., acceptance, experiential avoidance, congruency between values and actions) will be examined. This pilot trial will allow the study team to refine approaches to identify, recruit, and retain AYA participants and examine patterns of change in key outcome variables for the intervention and control arms. Information obtained will position the investigative team to examine the efficacy of the intervention in a larger randomized controlled trial.

Interventions

BEHAVIORALSymptom Management for Improved Physical and Emotional Wellbeing (SMILE)

Participating in the SMILE arm of the study will consist of four, 60-minute sessions delivered over 6-8 weeks to patients in their homes using videoconferencing. Intervention will provide training in behavioral symptom management skills (e.g.,relaxation training, activity-rest cycling) and include skills from ACT and MCP targeting avoidance of uncomfortable experiences (e.g., thoughts, emotions) and promoting engagement in value-directed activity.

BEHAVIORALEducation Control Arm

The control arm will receive the NCI booklet, Taking Time: Support for People with Cancer, which provides basic strategies for symptom (e.g., pain, fatigue, stress) management, coping with negative emotions, and communication and will continue their usual medical care of advanced cancer.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

* 15-29 years old * Diagnosis of advanced (i.e., diagnosis of incurable cancer or distant metastases) or recurrent cancer * Able to speak/read English

Exclusion criteria

* Active serious mental illness (e.g., schizophrenia) * Visual, hearing, or cognitive impairment Focus Group Caregiver Inclusion Criteria: * 18 years old and older * Ability to speak/read English Focus Group Caregiver

Design outcomes

Primary

MeasureTime frameDescription
Treatment Acceptability QuestionnairePost-treatment (6-8 weeks following the baseline assessment)The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 very unacceptable to 7 very acceptable) and averaged.
Session Attendance PercentagePost-treatment (6-8 weeks following the baseline assessment)Treatment feasibility will be assessed by measuring the session attendance percentage for each participant receiving the intervention.
Study Enrollment (Randomized Controlled Trial)12 months following the start of study enrollmentNumber of participants who enrolled in the randomized controlled trial phase of the study after being found eligible.
Pain Severity as Measured by the Brief Pain Inventory (BPI)Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedThe Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Participants rate their pain on a scale from 0 no pain to 10 pain as bad as you can imagine. Pain severity is calculated as the average of four items assessing participants' worst, least, current, and average (in the last week) pain on a scale from 0 no pain to 10 worst pain.
Pain Interference as Measured by the Brief Pain Inventory (BPI)Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedThe Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Pain interference is computed as the average of seven items, which ask about the interference of pain across different life domains (e.g., general activity, mood, relations with other people) in the past week on a scale from 0 Does not interfere to 10 Completely interferes. Higher scores indicate higher levels of pain interference.
Acceptance and ActionBaseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported7-Item: The Acceptance and Action Questionnaire-II assesses acceptance, experiential avoidance and psychological flexibility. Question scale ranges from 1, never true, to 7, always true. The total score ranges from 7 to 49, where a higher score indicates greater psychological inflexibility.
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedFatigue will be assessed using the PROMIS Computer Adaptive Test for Fatigue. Questions ask participants to rate their fatigue during the past 7 days. The T-score ranges from 0 to 100, where higher T-scores indicate greater fatigue. Scores are converted to standardized t-scores with a mean of 50 and standard deviation of 10. T-scores of 55 to \<60 indicate mild levels of fatigue, ≥60 to \<70 indicates moderate levels of fatigue, and ≥70 indicate severe levels of fatigue.
Depressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedDepressive Symptoms will be assessed using the PROMIS Computer Adaptive Test for Depression. Questions ask participants to respond to questions during the past 7 days. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of depression. T-scores of 55 to \<60 indicate mild levels of depression, ≥60 to \<70 indicates moderate levels of depression, and ≥70 indicate severe levels of depression.
Self-Efficacy as Measured by the Managing Chronic Disease ScaleBaseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedThe Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 not at all confident to 10 totally confident. The score for the scale is the mean of the six items, with higher number indicating higher self-efficacy.
Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedThe FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire. Responses for each item are on a scale from 0 = not at all to 4 = very much. Three subscale scores (Meaning, Peace, Faith) are calculated by summing specific items. Each subscale has 4 items, with total scores ranging from 0 to 16, with higher scores indicating greater well-being for each subscale (Meaning, Peace, or Faith). A total score is calculated as the sum of the three subscores, with total scores ranging from 0 to 48. Higher scores represent greater spiritual wellbeing.
Anxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedThe PROMIS Computer Adaptive Test for Anxiety will be used to assess anxiety symptoms in the last week. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of anxiety. T-scores of 55 to \<60 indicate mild levels of anxiety, ≥60 to \<70 indicates moderate levels of anxiety, and ≥70 indicate severe levels of anxiety.
Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)Post-treatment (6-8 weeks following the baseline assessment)The SSTS-R is a 13-item measure. The first 12-items ask participants to rate their satisfaction with the therapy received (6-items) or the therapist delivering the intervention (6-items) on a five-point scale ranging from 1 strongly disagree to 5 strongly disagree. Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater satisfaction. The 13th item (Global Improvement) asks, How much did the intervention help with your symptoms? with 5 answer choices ranging from 1 made things a lot worse to 5 made things a lot better, where higher scores indicate a better outcome.
Values as Measured by the Bulls Eye Values SurveyBaseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedThe Bulls Eye Values Survey assists participants with clarifying their values and will be used to examine participants' personal values, values attainment, and persistence towards values in the face of barriers. Part 1 asks the person to record values for 4 domains (work/education, relationships, personal growth/health, and leisure). Then, participants are asked to think of their values in each domain as bull's eye (the middle of the dart board). A 1 is equal to a hit in the bull's eye, which means that they are living completely in keeping with their value for that area of living. An 8 is equal to far from the bull's eye, which means that their life is way off the mark in terms of how they are living their life. Part 2 asks the person to identify obstacles to those values and rate from 1, doesn't prevent me at all, to 7, prevents me completely.
Use of Intervention StrategiesPost-treatment (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment; post-treatment (6-8 weeks following the baseline assessment) reportedParticipants' use of intervention strategies will be assessed using a measure developed specific to components of the proposed intervention. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 not at all to 4 6 or more days per week is used.
Living in Alignment With Values: The Valuing Questionnaire (VQ)Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reportedThe Valuing Questionnaire is a 10-item self-report questionnaire with a scale 0 = not true at all to 6 completely true. Two subscale scores are calculated, Progress and Obstruction, which typically have a negative correlation. Higher scores on the Progress subscale represent a closer alignment between one's internal values and one's actions. Higher scores on the Obstruction subscale represent more interference with living consistently with one's values. The range for both subscales is 0 to 30.

Countries

United States

Participant flow

Pre-assignment details

Two consented participants were lost to follow-up prior to completing the baseline assessment and were not randomized.

Participants by arm

ArmCount
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
Four, 60-minute sessions will provide training on behavioral symptom management skills, delivered over 6-8 weeks to patients in their homes using videoconferencing.
24
Education Control Arm
The control arm will receive the NCI booklet, Taking Time: Support for People with Cancer and otherwise continue their usual care.
16
Intervention Development (Patients)
Participants in this early stage of the study helped us to develop and refine the program that we subsequently used for the randomized controlled trial. These participants were patients who provided feedback on the program.
17
Intervention Development (Caregivers)
Participants in this early stage of the study helped us to develop and refine the program that we subsequently used for the randomized controlled trial. These participants were caregivers who provided feedback on the program.
13
Intervention Refinement
Participants in this early stage of the study helped us to develop and refine the program that we subsequently used for the randomized controlled trial. These participants were patients who tested the first iteration of the program and provided feedback.
3
Total73

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyDeath11100
Overall StudyLost to Follow-up11120

Baseline characteristics

CharacteristicSymptom Management for Improved Physical and Emotional Wellbeing (SMILE)Education Control ArmIntervention Development (Patients)Intervention Development (Caregivers)Intervention RefinementTotal
Age, Continuous24.42 years
STANDARD_DEVIATION 3.68
23.56 years
STANDARD_DEVIATION 3.93
23.47 years
STANDARD_DEVIATION 4.03
49.38 years
STANDARD_DEVIATION 11.41
23.00 years
STANDARD_DEVIATION 4.36
28.21 years
STANDARD_DEVIATION 11.34
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants13 Participants1 Participants0 Participants0 Participants17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants2 Participants16 Participants12 Participants3 Participants54 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants0 Participants0 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
4 Participants4 Participants4 Participants2 Participants0 Participants14 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
White
16 Participants11 Participants13 Participants9 Participants3 Participants52 Participants
Sex: Female, Male
Female
16 Participants8 Participants4 Participants10 Participants3 Participants41 Participants
Sex: Female, Male
Male
8 Participants8 Participants13 Participants3 Participants0 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
1 / 241 / 161 / 170 / 130 / 3
other
Total, other adverse events
0 / 240 / 160 / 170 / 130 / 3
serious
Total, serious adverse events
0 / 240 / 160 / 170 / 130 / 3

Outcome results

Primary

Acceptance and Action

7-Item: The Acceptance and Action Questionnaire-II assesses acceptance, experiential avoidance and psychological flexibility. Question scale ranges from 1, never true, to 7, always true. The total score ranges from 7 to 49, where a higher score indicates greater psychological inflexibility.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up and two participants with missing data on at least one item of the subscale; Education Control Arm: One participant lost to follow-up and one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Acceptance and ActionBaseline21.19 score on a scaleStandard Deviation 10.25
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Acceptance and ActionPost-treatment19.19 score on a scaleStandard Deviation 9.91
Education Control ArmAcceptance and ActionBaseline17.50 score on a scaleStandard Deviation 9.15
Education Control ArmAcceptance and ActionPost-treatment18.43 score on a scaleStandard Deviation 8.25
Primary

Anxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

The PROMIS Computer Adaptive Test for Anxiety will be used to assess anxiety symptoms in the last week. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of anxiety. T-scores of 55 to \<60 indicate mild levels of anxiety, ≥60 to \<70 indicates moderate levels of anxiety, and ≥70 indicate severe levels of anxiety.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up; Education Control Arm: One participant lost to follow-up and one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Anxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline58.06 T-scoreStandard Deviation 10.44
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Anxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Post-treatment53.81 T-scoreStandard Deviation 9.73
Education Control ArmAnxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline56.64 T-scoreStandard Deviation 10.48
Education Control ArmAnxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Post-treatment53.91 T-scoreStandard Deviation 10.4
Primary

Depressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

Depressive Symptoms will be assessed using the PROMIS Computer Adaptive Test for Depression. Questions ask participants to respond to questions during the past 7 days. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of depression. T-scores of 55 to \<60 indicate mild levels of depression, ≥60 to \<70 indicates moderate levels of depression, and ≥70 indicate severe levels of depression.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up; Education Control Arm: One participant lost to follow-up one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Depressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline56.15 T-scoreStandard Deviation 7.56
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Depressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Post-treatment51.35 T-scoreStandard Deviation 8.73
Education Control ArmDepressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline52.95 T-scoreStandard Deviation 10.28
Education Control ArmDepressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Post-treatment52.06 T-scoreStandard Deviation 10.41
Primary

Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)

Fatigue will be assessed using the PROMIS Computer Adaptive Test for Fatigue. Questions ask participants to rate their fatigue during the past 7 days. The T-score ranges from 0 to 100, where higher T-scores indicate greater fatigue. Scores are converted to standardized t-scores with a mean of 50 and standard deviation of 10. T-scores of 55 to \<60 indicate mild levels of fatigue, ≥60 to \<70 indicates moderate levels of fatigue, and ≥70 indicate severe levels of fatigue.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up; Education Control Arm: One participant lost to follow-up one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline58.64 T-scoreStandard Deviation 9.39
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Post-treatment54.67 T-scoreStandard Deviation 8.12
Education Control ArmFatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Baseline54.23 T-scoreStandard Deviation 8.87
Education Control ArmFatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)Post-treatment51.24 T-scoreStandard Deviation 8.99
Primary

Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)

The SSTS-R is a 13-item measure. The first 12-items ask participants to rate their satisfaction with the therapy received (6-items) or the therapist delivering the intervention (6-items) on a five-point scale ranging from 1 strongly disagree to 5 strongly disagree. Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater satisfaction. The 13th item (Global Improvement) asks, How much did the intervention help with your symptoms? with 5 answer choices ranging from 1 made things a lot worse to 5 made things a lot better, where higher scores indicate a better outcome.

Time frame: Post-treatment (6-8 weeks following the baseline assessment)

Population: Only participants receiving one intervention session had data analyzed. One of these participants had missing data on this item.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)Satisfaction with therapy subscale26.42 score on a scaleStandard Deviation 2.81
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)Satisfaction with therapist subscale27.57 score on a scaleStandard Deviation 3.1
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)How much did this intervention help with symptoms?4.40 score on a scaleStandard Deviation 0.5
Primary

Living in Alignment With Values: The Valuing Questionnaire (VQ)

The Valuing Questionnaire is a 10-item self-report questionnaire with a scale 0 = not true at all to 6 completely true. Two subscale scores are calculated, Progress and Obstruction, which typically have a negative correlation. Higher scores on the Progress subscale represent a closer alignment between one's internal values and one's actions. Higher scores on the Obstruction subscale represent more interference with living consistently with one's values. The range for both subscales is 0 to 30.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: Progress - 1 participant lost to follow-up and 2 participants with missing data at least one item of the subscale; Obstruction - 1 participant lost to follow-up and 1 participant with missing data on at least one item of the subscale~Education Control Arm: Progress - 1 participant lost to follow-up and 1 participant died prior to completion of the A2 assessment; Obstruction - 1 participant lost to follow-up and 1 participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Living in Alignment With Values: The Valuing Questionnaire (VQ)Baseline: Progress17.05 score on a scaleStandard Deviation 5.57
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Living in Alignment With Values: The Valuing Questionnaire (VQ)Post-treatment: Progress18.43 score on a scaleStandard Deviation 5.58
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Living in Alignment With Values: The Valuing Questionnaire (VQ)Baseline: Obstruction13.68 score on a scaleStandard Deviation 5.92
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Living in Alignment With Values: The Valuing Questionnaire (VQ)Post-treatment: Obstruction9.50 score on a scaleStandard Deviation 6.46
Education Control ArmLiving in Alignment With Values: The Valuing Questionnaire (VQ)Post-treatment: Obstruction11.43 score on a scaleStandard Deviation 6.79
Education Control ArmLiving in Alignment With Values: The Valuing Questionnaire (VQ)Baseline: Progress20.50 score on a scaleStandard Deviation 6.04
Education Control ArmLiving in Alignment With Values: The Valuing Questionnaire (VQ)Baseline: Obstruction10.07 score on a scaleStandard Deviation 6.71
Education Control ArmLiving in Alignment With Values: The Valuing Questionnaire (VQ)Post-treatment: Progress17.93 score on a scaleStandard Deviation 6.66
Primary

Pain Interference as Measured by the Brief Pain Inventory (BPI)

The Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Pain interference is computed as the average of seven items, which ask about the interference of pain across different life domains (e.g., general activity, mood, relations with other people) in the past week on a scale from 0 Does not interfere to 10 Completely interferes. Higher scores indicate higher levels of pain interference.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up; Education Control Arm: One participant lost to follow-up and one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Pain Interference as Measured by the Brief Pain Inventory (BPI)Baseline2.53 score on a scaleStandard Deviation 2.3
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Pain Interference as Measured by the Brief Pain Inventory (BPI)Post-treatment1.91 score on a scaleStandard Deviation 2.04
Education Control ArmPain Interference as Measured by the Brief Pain Inventory (BPI)Baseline2.45 score on a scaleStandard Deviation 2.66
Education Control ArmPain Interference as Measured by the Brief Pain Inventory (BPI)Post-treatment2.07 score on a scaleStandard Deviation 2.6
Primary

Pain Severity as Measured by the Brief Pain Inventory (BPI)

The Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Participants rate their pain on a scale from 0 no pain to 10 pain as bad as you can imagine. Pain severity is calculated as the average of four items assessing participants' worst, least, current, and average (in the last week) pain on a scale from 0 no pain to 10 worst pain.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up, one participant with missing data; Education Control Arm: One participant lost to follow-up, one participant with missing data, and one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Pain Severity as Measured by the Brief Pain Inventory (BPI)Baseline2.49 score on a scaleStandard Deviation 2.35
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Pain Severity as Measured by the Brief Pain Inventory (BPI)Post-treatment2.28 score on a scaleStandard Deviation 1.85
Education Control ArmPain Severity as Measured by the Brief Pain Inventory (BPI)Baseline2.10 score on a scaleStandard Deviation 1.89
Education Control ArmPain Severity as Measured by the Brief Pain Inventory (BPI)Post-treatment2.25 score on a scaleStandard Deviation 1.88
Primary

Self-Efficacy as Measured by the Managing Chronic Disease Scale

The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 not at all confident to 10 totally confident. The score for the scale is the mean of the six items, with higher number indicating higher self-efficacy.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up; Education Control Arm: One participant lost to follow-up one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Self-Efficacy as Measured by the Managing Chronic Disease ScaleBaseline6.75 score on a scaleStandard Deviation 1.88
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Self-Efficacy as Measured by the Managing Chronic Disease ScalePost-treatment7.89 score on a scaleStandard Deviation 1.65
Education Control ArmSelf-Efficacy as Measured by the Managing Chronic Disease ScaleBaseline7.00 score on a scaleStandard Deviation 2.19
Education Control ArmSelf-Efficacy as Measured by the Managing Chronic Disease ScalePost-treatment6.90 score on a scaleStandard Deviation 2.17
Primary

Session Attendance Percentage

Treatment feasibility will be assessed by measuring the session attendance percentage for each participant receiving the intervention.

Time frame: Post-treatment (6-8 weeks following the baseline assessment)

Population: Outcome only applicable to the SMILE Intervention arm.

ArmMeasureValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Session Attendance Percentage80.20 percentage of sessionsStandard Deviation 39.69
Primary

Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)

The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire. Responses for each item are on a scale from 0 = not at all to 4 = very much. Three subscale scores (Meaning, Peace, Faith) are calculated by summing specific items. Each subscale has 4 items, with total scores ranging from 0 to 16, with higher scores indicating greater well-being for each subscale (Meaning, Peace, or Faith). A total score is calculated as the sum of the three subscores, with total scores ranging from 0 to 48. Higher scores represent greater spiritual wellbeing.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention: One participant lost to follow-up; Education Control Arm: One participant lost to follow-up and one participant died prior to completion of the A2 assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Meaning11.61 score on a scaleStandard Deviation 3.93
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Meaning12.48 score on a scaleStandard Deviation 2.53
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Peace8.87 score on a scaleStandard Deviation 3.77
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Peace10.28 score on a scaleStandard Deviation 3.73
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Faith9.87 score on a scaleStandard Deviation 5.81
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Faith11.35 score on a scaleStandard Deviation 5.07
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Total30.35 score on a scaleStandard Deviation 10.51
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Total34.10 score on a scaleStandard Deviation 10.39
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Total28.00 score on a scaleStandard Deviation 12.31
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Meaning12.5 score on a scaleStandard Deviation 3.03
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Faith8.43 score on a scaleStandard Deviation 5.33
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Meaning11.0 score on a scaleStandard Deviation 4.54
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Total30.21 score on a scaleStandard Deviation 10.22
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Baseline: Peace9.29 score on a scaleStandard Deviation 4.08
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Faith8.50 score on a scaleStandard Deviation 4.96
Education Control ArmSpritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)Post-treatment: Peace8.50 score on a scaleStandard Deviation 4.47
Primary

Study Enrollment (Randomized Controlled Trial)

Number of participants who enrolled in the randomized controlled trial phase of the study after being found eligible.

Time frame: 12 months following the start of study enrollment

Population: This measure is for individuals who were eligible for the randomized controlled trial. Only patients who were screened for eligibility to participate in the randomized controlled trial are included in this outcome measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Study Enrollment (Randomized Controlled Trial)42 Participants
Primary

Treatment Acceptability Questionnaire

The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 very unacceptable to 7 very acceptable) and averaged.

Time frame: Post-treatment (6-8 weeks following the baseline assessment)

Population: This measure was only provided to participants who received the SMILE Intervention and analyzed among participants receiving at least one AYA SMILE session (n=20) were included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Treatment Acceptability Questionnaire6.02 score on a scaleStandard Deviation 0.76
Primary

Use of Intervention Strategies

Participants' use of intervention strategies will be assessed using a measure developed specific to components of the proposed intervention. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 not at all to 4 6 or more days per week is used.

Time frame: Post-treatment (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment; post-treatment (6-8 weeks following the baseline assessment) reported

Population: This measure was only provided to participants who received the SMILE Intervention and analyzed among participants receiving at least one AYA SMILE session (n=20) were included in the analysis.

ArmMeasureValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Use of Intervention Strategies2.1 score on a scaleStandard Deviation 0.97
Primary

Values as Measured by the Bulls Eye Values Survey

The Bulls Eye Values Survey assists participants with clarifying their values and will be used to examine participants' personal values, values attainment, and persistence towards values in the face of barriers. Part 1 asks the person to record values for 4 domains (work/education, relationships, personal growth/health, and leisure). Then, participants are asked to think of their values in each domain as bull's eye (the middle of the dart board). A 1 is equal to a hit in the bull's eye, which means that they are living completely in keeping with their value for that area of living. An 8 is equal to far from the bull's eye, which means that their life is way off the mark in terms of how they are living their life. Part 2 asks the person to identify obstacles to those values and rate from 1, doesn't prevent me at all, to 7, prevents me completely.

Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported

Population: SMILE Intervention arm: Work/education, relationships, personal growth/health, leisure: One participant lost to follow-up and two participants had missing data.~SMILE Intervention arm: Obstacles: One participant lost to follow-up and four participants had missing data.~Education Control Arm: One participant lost to follow-up, one participant died prior to completion of the A2 assessment, and one participant had missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyBaseline: Work/Education4.43 score on a scaleStandard Deviation 1.94
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyPost-treatment: Work/Education4.71 score on a scaleStandard Deviation 2.26
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyBaseline: Leisure4.62 score on a scaleStandard Deviation 1.88
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyPost-treatment: Leisure4.48 score on a scaleStandard Deviation 1.89
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyBaseline: Relationships4.43 score on a scaleStandard Deviation 2.29
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyPost-treatment: Relationship4.43 score on a scaleStandard Deviation 1.99
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyBaseline: Personal growth/health4.95 score on a scaleStandard Deviation 2.11
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyPost-treatment: Personal growth/health4.95 score on a scaleStandard Deviation 1.96
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyBaseline: Obstacles4.89 score on a scaleStandard Deviation 1.41
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Values as Measured by the Bulls Eye Values SurveyPost-treatment: Obstacles4.32 score on a scaleStandard Deviation 1.6
Education Control ArmValues as Measured by the Bulls Eye Values SurveyPost-treatment: Personal growth/health4.08 score on a scaleStandard Deviation 1.98
Education Control ArmValues as Measured by the Bulls Eye Values SurveyBaseline: Work/Education4.15 score on a scaleStandard Deviation 1.91
Education Control ArmValues as Measured by the Bulls Eye Values SurveyPost-treatment: Relationship3.62 score on a scaleStandard Deviation 2.6
Education Control ArmValues as Measured by the Bulls Eye Values SurveyPost-treatment: Work/Education3.54 score on a scaleStandard Deviation 1.85
Education Control ArmValues as Measured by the Bulls Eye Values SurveyPost-treatment: Obstacles4.54 score on a scaleStandard Deviation 1.51
Education Control ArmValues as Measured by the Bulls Eye Values SurveyBaseline: Leisure3.23 score on a scaleStandard Deviation 2.05
Education Control ArmValues as Measured by the Bulls Eye Values SurveyBaseline: Personal growth/health4.46 score on a scaleStandard Deviation 2.47
Education Control ArmValues as Measured by the Bulls Eye Values SurveyPost-treatment: Leisure4.23 score on a scaleStandard Deviation 1.59
Education Control ArmValues as Measured by the Bulls Eye Values SurveyBaseline: Obstacles4.31 score on a scaleStandard Deviation 1.8
Education Control ArmValues as Measured by the Bulls Eye Values SurveyBaseline: Relationships3.54 score on a scaleStandard Deviation 2.33

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026