Breast Cancer, Cancer, Endocrine Cancer, Fatigue, Germ Cell Tumor, Hematologic Cancer, Melanoma, Pain, Psychological Distress, Young Adult
Conditions
Keywords
Cancer, Young Adult, Behavioral Symptom Management
Brief summary
Symptom interference is common for survivors of young adult cancer (aged 18-39 at diagnosis) and impacts their abilities to achieve normative life goals (e.g., education, careers, independence, romantic/social relationships) as well as adhere to recommended follow-up care. Assistance with symptom management has been rated by young adult survivors as an important and unmet healthcare need; however, skill-based symptom management interventions have typically been tested among older cancer survivors and have not targeted the unique developmental needs of those diagnosed as young adults. The proposed research advances the health and wellbeing of young adult cancer survivors by creating a developmentally appropriate hybrid in-person/mHealth behavioral symptom management intervention which addresses variables (i.e., symptoms and symptom interference) consistently linked to significant social, economic, and health burden.
Detailed description
More than 60,000 young adults (YAs) aged 18-39 are diagnosed with cancer in the US each year. Advances in treatment have yielded five year survival rates \>70% suggesting that the majority of YAs will become long-term cancer survivors. Symptom (e.g., pain, fatigue, distress) interference is common for YA cancer survivors and impacts their abilities to achieve normative life goals (e.g., returning to work/school, achieving autonomy, pursuing social/romantic relationships) and adhere to recommended follow-up care. Symptom management has been identified as a significant issue in the transition to survivorship for YAs by the Institute of Medicine and National Cancer Institute, and assistance with symptom management is rated as an important and unmet need by YA survivors. Yet, behavioral symptom management interventions have not targeted the needs of those diagnosed as YAs. The proposed study aims to develop and test the feasibility and acceptability of a novel behavioral symptom management intervention designed for survivors of YA cancer (cancer types: hematologic, breast, or gastrointestinal cancers, melanoma, or germ cell tumors). The hybrid intervention will include inperson, group sessions and an integrated mobile application. The intervention will provide peer support while also teaching skills to improve symptoms, symptom interference, and self-efficacy for symptom management. The mobile application will assist with symptom monitoring, home skills practice, and connecting with group members. The preliminary version of the intervention will be guided by the research team's prior work developing and testing symptom management interventions for cancer survivors, national guidelines for YA oncology, consultation with an expert advisory board, and input from patient (n=20) and provider N=10) stakeholders. The intervention will be further refined following review by patient user testers (n=10). Next, feasibility, acceptability, and distributions of change over time as well as relationships between outcome variables will be examined through a pilot randomized clinical trial of the developed intervention. Participants (N=60) will be randomized to intervention or wait-list control arms. Primary study outcomes are symptom (pain, fatigue, distress) severity and symptom interference. Self-efficacy and support will also be examined as mediators of change in outcome variables. The proposed study has the potential to make several significant contributions by targeting an underserved group of cancer survivors, addressing a critical gap in care, and addressing variables consistently linked to social, economic, and health burden for YAs. It will also provide important information about approaches to identify, recruit, and retain YA cancer survivors in research and provide pilot data for a larger trial.
Interventions
BEHAVIORALBehavioral Symptom Management for Young Adult Cancer Survivors
The intervention includes group sessions held over Zoom along with an integrated mobile application to provide participants with instruction in cognitive and behavioral strategies for managing symptoms (i.e., pain, fatigue, distress). The developed intervention includes 8 face-to-face group sessions (12 therapy hours). Sessions are delivered using a faded contact approach (i.e., sessions 1-6: weekly, sessions 7-8: biweekly). Participants receive secure access to a study-specific mobile application that includes: 1) audio and video files and brief text-based educational content reviewing strategies discussed during the groups; 2) the ability to self-monitor symptom severity; 3) the ability to connect with group members via a social networking platform; and 4) activity tracking synchronization.
Sponsors
National Cancer Institute (NCI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A two-arm, pilot RCT employing a wait-list control arm will be used. Six cohorts of YA survivors (n=10/cohort) are randomized within their cohort with equal allocation to the intervention or control arms. Randomization was stratified by gender.
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
Young Adult Cancer Survivors Participating in Intervention Development Interviews Eligibility Criteria * Diagnosed with hematologic, breast, gastrointestinal, or endocrine cancers, melanoma, or germ cell tumors * Diagnosed with cancer as a young adult * Under the care of a medical provider at the Duke Cancer Institute * Completed curative treatment involving multimodal therapy within the last five years * Able to speak and read English * Able to give informed consent
Exclusion criteria
* Nonambulatory * Major mental illness, i.e., schizophrenia * Untreated or uncontrolled mental illness, i.e., bipolar * Residence greater than 100 miles from the research site Medical Providers Participating in Intervention Development Interviews Eligibility criteria o Provide care to young adult cancer survivors at the Duke Cancer Institute Young Adult Cancer Survivor User Testers Eligibility Criteria * Diagnosed with hematologic, breast, gastrointestinal cancers, or endocrine cancers, melanoma, or germ cell tumors * Diagnosed with cancer as a young adult * Under the care of a medical provider at the Duke Cancer Institute * Completed curative treatment involving multimodal therapy within the last five years * Able to speak and read English * Able to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Use of the Mobile Application | Following completion of the intervention, up to 12 months | Participants' use of the mobile application will be assessed using a measure developed specific to components of the proposed mobile application. Participants will be asked about how frequently they have used components of the mobile application 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 5 2 or more times a day will be used. |
| Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Following completion of the intervention, up to 12 months | Intervention satisfaction will be assessed using the Satisfaction witth Therapy and Therapist Scale-Revised, a 13-item measure with the first 12-items on a five-point scale ranging from 1 strongly disagree to 5 strongly agree. The 13th item (Global Improvement) asks, How much did the intervention help with your symptoms? with 5 answer choices ranging from made things a lot better (1) to made things a lot worse (5). Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater overall satisfaction. A total score is calculated as the sum of the first twelve items, with possible scores from 12 to 60, with higher scores indicating greater overall satisfaction. |
| Number of Participants Who Completed Open-Ended Questions About the Program | Following completion of the intervention, up to 12 months | Intervention will be evaluated using 3 open-ended questions, including the following: 1) What was the most helpful part of the program?, 2) What was the least helpful part of the program?, and 3) What suggestions do you have for us to help improve the program? |
| Percentage of Sessions Attended by Each Participant | Following completion of the intervention, up to 12 months | Treatment feasibility will be assessed by measuring the session attendance rate for each participant. |
| Treatment Acceptability Questionnaire | Following completion of the intervention, up to 12 months | 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. |
| Use of Intervention Strategies | Following completion of the intervention, up to 12 months | 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 5 every day will be used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety: PROMIS Anxiety Short Form | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported | Symptoms of Anxiety will be assessed using the Patient Reported Outcomes Measurement Information System Anxiety Short Form-8a, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., I felt nervous, I felt tense) using a five-point scale ranging from 1 never to 5 always. Total scores are then converted to T-scores. Items are summed and 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 greater than 70 indicate severe levels of anxiety. |
| Change in Symptom Interference: Illness Intrusiveness Rating Scale | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported | Symptom interference will be assessed using the Illness Intrusiveness Rating Scale (IIRS). The IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation). Items are rated on a 7-point scale from 1 not very much to 7 very much. The total score ranges from 7 to 91, where a higher score indicates greater interference. |
| Change in Pain: Brief Pain Inventory | Baseline and again 3, 6, 9, and 12 months following the baseline assessment; pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported | 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. 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). |
| Change in Fatigue: PROMIS Fatigue Short Form | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported | Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., In the past 7 days, how run-down did you feel, on average?). Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. A higher score indicates greater fatigue. T-scores of 55 to 60 indicate mild levels of fatigue, 60 to 70 indicates moderate levels of fatigue, and greater than 70 indicate severe levels of fatigue. |
| Change in Depressive Symptoms: PROMIS Depression Short Form | Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported | Depressive Symptoms will be assessed using the Patient Reported Outcomes Measurement Information System Depression Short Form-8a, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., I felt sad, I felt helpless) using a five-point scale ranging from 1 never to 5 always. Items are summed and 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 greater than 70 indicate severe levels of depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Activity: International Physical Activity Questionnaire | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The International Physical Activity Questionnaire is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven |
| Change in Informational Support: PROMIS Informational Support-Short Form | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The PROMIS Informational Support Short Form is a 6-item measure used to assess informational support. Participants are asked to rate each item (e.g., I have someone to turn to for suggestions about how to deal with a problem, I have someone to give me information if I need it) on a scale from 1= never to 5= always. |
| Change in Activity: Stanford Leisure-Time Activity Categorical Item (LCAT) | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The Stanford LCAT is a categorical item that assesses the type of physical activities participants do. |
| Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT) | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = not at all to 4 = very much. |
| Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ) | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The AAQ is a 7-item questionnaire to track psychological flexibility related to coping with cancer and cancer treatment. The scale ranges from 1 = never true to 7 always true. Item is scored by adding all of the responses together. |
| Changes in Living in Alignment With Values: The Valuing Questionnaire (VQ) | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The VQ is a 10-item self-report questionnaire with a scale 0 = not true at all to 6 completely true. |
| Group Therapy Experiences Scale | Following completion of the intervention, up to 12 months | The 17-item Group Therapy Experiences Scale will be used to assess the level of cohesion among group members (e.g., development of positive relationships, comfort level with other group members). Items 1-16 are rated on a 5-point scale with 1 = strongly agree to 5 = strongly disagree. Item 17 is an open-ended question, was there something in the group today that helped or hindered you?relationships, comfort level with other group members). Items are rated on a 4-point scale with 1= strongly disagree to 4= strongly agree. |
| Change in Social Isolation: PROMIS Social Isolation Scale | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The PROMIS Social Isolation Scale is a 6-item measure is used to assess social isolation. Participants are asked to rate each item (e.g., I felt left out, I feel that people avoid talking to me) on a scale from 1= never to 5= always. |
| Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | 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. |
| Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a is a 4-item scale. Participants rate their confidence in managing their symptoms during daily activities, with relationships with friends and family, in a public place, and working with their doctor to manage these symptoms on a scale from 1 = I am not at all confident to 5 I am very confident. |
| Change in Emotional Support: PROMIS Emotional Support-Short Form | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The PROMIS Emotional Support Short Form is a 6-item measure used to assess emotional support. Participants are asked to rate each item (I have someone who will listen to me when I need to talk, I have someone to talk with when I have a bad day) on a scale from 1= never to 5= always. |
| Change in Instrumental Support: PROMIS Instrumental Support-Short Form | Baseline and again 3, 6, 9, and 12 months following the baseline assessment | The PROMIS Instrumental Support Short Form is a 6-item measure used to assess instrumental support. Participants are asked to rate each item (e.g., Do you have someone to take you to the doctor if you needed it?, Do you have someone to prepare your meals if you are unable to do it yourself?) on a scale from 1= never to 5= always. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a comprehensive cancer center.
Pre-assignment details
Of 65 enrolled patients, 4 patients were excluded prior to randomization: two lost to follow up, one subject withdrawal, and one PI withdrawal due to disease progression.
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms. | 31 |
| Waitlist Control Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study. | 30 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period | Lost to Follow-up | 6 | 5 |
| Treatment Period | Physician Decision | 0 | 2 |
Baseline characteristics
| Characteristic | Behavioral Symptom Management for Young Adult Cancer Survivors | Total | Waitlist Control |
|---|---|---|---|
| Age, Continuous | 33 years | 34 years | 34 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 56 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 24 Participants | 44 Participants | 20 Participants |
| Region of Enrollment United States | 31 Participants | 61 Participants | 30 Participants |
| Sex: Female, Male Female | 22 Participants | 44 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 17 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 27 | 0 / 3 |
| other Total, other adverse events | 0 / 31 | 0 / 27 | 0 / 3 |
| serious Total, serious adverse events | 0 / 31 | 0 / 27 | 0 / 3 |
Outcome results
Primary
Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R)
Intervention satisfaction will be assessed using the Satisfaction witth Therapy and Therapist Scale-Revised, a 13-item measure with the first 12-items on a five-point scale ranging from 1 strongly disagree to 5 strongly agree. The 13th item (Global Improvement) asks, How much did the intervention help with your symptoms? with 5 answer choices ranging from made things a lot better (1) to made things a lot worse (5). Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater overall satisfaction. A total score is calculated as the sum of the first twelve items, with possible scores from 12 to 60, with higher scores indicating greater overall satisfaction.
Time frame: Following completion of the intervention, up to 12 months
Population: Participants who completed at least one intervention session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Satisfaction With Therapy (ST) | 26.71 scores on a scale | Standard Deviation 3.52 |
| Behavioral Symptom Management for Young Adult Cancer Survivors | Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Satisfaction With Therapist (SWT) | 28.86 scores on a scale | Standard Deviation 1.86 |
| Behavioral Symptom Management for Young Adult Cancer Survivors | Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Global Improvement (Item 13) | 1.75 scores on a scale | Standard Deviation 0.52 |
| Waitlist Control | Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Satisfaction With Therapist (SWT) | 27.75 scores on a scale | Standard Deviation 3.27 |
| Waitlist Control | Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Global Improvement (Item 13) | 1.58 scores on a scale | Standard Deviation 0.65 |
| Waitlist Control | Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) | Satisfaction With Therapy (ST) | 27.33 scores on a scale | Standard Deviation 3.14 |
Comparison: Satisfaction with Therapy (ST)p-value: 0.519t-test, 2 sided
Comparison: Satisfaction with Therapist (SWT)p-value: 0.15t-test, 2 sided
Comparison: Global Improvement (Item 13)p-value: 0.309t-test, 2 sided
Primary
Number of Participants Who Completed Open-Ended Questions About the Program
Intervention will be evaluated using 3 open-ended questions, including the following: 1) What was the most helpful part of the program?, 2) What was the least helpful part of the program?, and 3) What suggestions do you have for us to help improve the program?
Time frame: Following completion of the intervention, up to 12 months
Population: Participants who completed at least one intervention session.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Number of Participants Who Completed Open-Ended Questions About the Program | 28 Participants |
| Waitlist Control | Number of Participants Who Completed Open-Ended Questions About the Program | 24 Participants |
Primary
Percentage of Sessions Attended by Each Participant
Treatment feasibility will be assessed by measuring the session attendance rate for each participant.
Time frame: Following completion of the intervention, up to 12 months
Population: Any participant who had at least one intervention session was included for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Percentage of Sessions Attended by Each Participant | 91.96 percentage of sessions | Standard Deviation 23.87 |
| Waitlist Control | Percentage of Sessions Attended by Each Participant | 94.27 percentage of sessions | Standard Deviation 18.42 |
p-value: 0.696t-test, 2 sided
Primary
Self-reported Use of the Mobile Application
Participants' use of the mobile application will be assessed using a measure developed specific to components of the proposed mobile application. Participants will be asked about how frequently they have used components of the mobile application 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 5 2 or more times a day will be used.
Time frame: Following completion of the intervention, up to 12 months
Population: Any participant who had at least one intervention session was included for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Self-reported Use of the Mobile Application | 0.79 score on a scale | Standard Deviation 0.9 |
| Waitlist Control | Self-reported Use of the Mobile Application | 0.96 score on a scale | Standard Deviation 1.37 |
Comparison: Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.p-value: 0.6Fisher Exact
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: Following completion of the intervention, up to 12 months
Population: One participant in the waitlist control condition was excluded from analysis due to an incomplete response to the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Treatment Acceptability Questionnaire | 6.54 score on a scale | Standard Deviation 0.41 |
| Waitlist Control | Treatment Acceptability Questionnaire | 6.36 score on a scale | Standard Deviation 0.83 |
p-value: 0.35t-test, 2 sided
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 5 every day will be used.
Time frame: Following completion of the intervention, up to 12 months
Population: Any participant who had at least one intervention session was included for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Use of Intervention Strategies | 2.35 score on a scale | Standard Deviation 0.83 |
| Waitlist Control | Use of Intervention Strategies | 2.67 score on a scale | Standard Deviation 1.24 |
Comparison: Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.p-value: 0.274Fisher Exact
Secondary
Change in Anxiety: PROMIS Anxiety Short Form
Symptoms of Anxiety will be assessed using the Patient Reported Outcomes Measurement Information System Anxiety Short Form-8a, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., I felt nervous, I felt tense) using a five-point scale ranging from 1 never to 5 always. Total scores are then converted to T-scores. Items are summed and 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 greater than 70 indicate severe levels of anxiety.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Population: Respondents were included if they provided a complete response to the measure. All participants received the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Change in Anxiety: PROMIS Anxiety Short Form | 53.1 T-score | Standard Deviation 12 |
| Waitlist Control | Change in Anxiety: PROMIS Anxiety Short Form | 52.6 T-score | Standard Deviation 12 |
p-value: 0.6153Wilcoxon (Mann-Whitney)
Secondary
Change in Depressive Symptoms: PROMIS Depression Short Form
Depressive Symptoms will be assessed using the Patient Reported Outcomes Measurement Information System Depression Short Form-8a, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., I felt sad, I felt helpless) using a five-point scale ranging from 1 never to 5 always. Items are summed and 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 greater than 70 indicate severe levels of depression.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Population: Respondents were included if they provided a complete response to the measure. All participants received the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Change in Depressive Symptoms: PROMIS Depression Short Form | 50.3 T-score | Standard Deviation 10.2 |
| Waitlist Control | Change in Depressive Symptoms: PROMIS Depression Short Form | 48.7 T-score | Standard Deviation 9.6 |
p-value: 0.1848Wilcoxon (Mann-Whitney)
Secondary
Change in Fatigue: PROMIS Fatigue Short Form
Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., In the past 7 days, how run-down did you feel, on average?). Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. A higher score indicates greater fatigue. T-scores of 55 to 60 indicate mild levels of fatigue, 60 to 70 indicates moderate levels of fatigue, and greater than 70 indicate severe levels of fatigue.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Population: All participants received the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Change in Fatigue: PROMIS Fatigue Short Form | 54 T-score | Standard Deviation 10.8 |
| Waitlist Control | Change in Fatigue: PROMIS Fatigue Short Form | 55.4 T-score | Standard Deviation 9.3 |
p-value: 0.3512Wilcoxon (Mann-Whitney)
Secondary
Change in Pain: Brief Pain Inventory
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. 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).
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment; pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Population: Respondents were included if they provided a complete response to the measure. All participants received the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Change in Pain: Brief Pain Inventory | Pain Severity | 2.1 score on a scale | Standard Deviation 2 |
| Behavioral Symptom Management for Young Adult Cancer Survivors | Change in Pain: Brief Pain Inventory | Pain Interference | 2.2 score on a scale | Standard Deviation 2.3 |
| Waitlist Control | Change in Pain: Brief Pain Inventory | Pain Severity | 1.7 score on a scale | Standard Deviation 1.9 |
| Waitlist Control | Change in Pain: Brief Pain Inventory | Pain Interference | 1.9 score on a scale | Standard Deviation 2.3 |
p-value: 0.0265Wilcoxon (Mann-Whitney)
p-value: 0.2084Wilcoxon (Mann-Whitney)
Secondary
Change in Symptom Interference: Illness Intrusiveness Rating Scale
Symptom interference will be assessed using the Illness Intrusiveness Rating Scale (IIRS). The IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation). Items are rated on a 7-point scale from 1 not very much to 7 very much. The total score ranges from 7 to 91, where a higher score indicates greater interference.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Population: Respondents were included if they provided a complete response to the measure. All participants received the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Symptom Management for Young Adult Cancer Survivors | Change in Symptom Interference: Illness Intrusiveness Rating Scale | 36.4 score on a scale | Standard Deviation 20 |
| Waitlist Control | Change in Symptom Interference: Illness Intrusiveness Rating Scale | 32.8 score on a scale | Standard Deviation 17.4 |
p-value: 0.0563Wilcoxon (Mann-Whitney)
Other Pre-specified
Change in Activity: International Physical Activity Questionnaire
The International Physical Activity Questionnaire is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Activity: Stanford Leisure-Time Activity Categorical Item (LCAT)
The Stanford LCAT is a categorical item that assesses the type of physical activities participants do.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Emotional Support: PROMIS Emotional Support-Short Form
The PROMIS Emotional Support Short Form is a 6-item measure used to assess emotional support. Participants are asked to rate each item (I have someone who will listen to me when I need to talk, I have someone to talk with when I have a bad day) on a scale from 1= never to 5= always.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Informational Support: PROMIS Informational Support-Short Form
The PROMIS Informational Support Short Form is a 6-item measure used to assess informational support. Participants are asked to rate each item (e.g., I have someone to turn to for suggestions about how to deal with a problem, I have someone to give me information if I need it) on a scale from 1= never to 5= always.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Instrumental Support: PROMIS Instrumental Support-Short Form
The PROMIS Instrumental Support Short Form is a 6-item measure used to assess instrumental support. Participants are asked to rate each item (e.g., Do you have someone to take you to the doctor if you needed it?, Do you have someone to prepare your meals if you are unable to do it yourself?) on a scale from 1= never to 5= always.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a
The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a is a 4-item scale. Participants rate their confidence in managing their symptoms during daily activities, with relationships with friends and family, in a public place, and working with their doctor to manage these symptoms on a scale from 1 = I am not at all confident to 5 I am very confident.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Self-Efficacy: The Self-Efficacy for 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.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Social Isolation: PROMIS Social Isolation Scale
The PROMIS Social Isolation Scale is a 6-item measure is used to assess social isolation. Participants are asked to rate each item (e.g., I felt left out, I feel that people avoid talking to me) on a scale from 1= never to 5= always.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)
The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = not at all to 4 = very much.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ)
The AAQ is a 7-item questionnaire to track psychological flexibility related to coping with cancer and cancer treatment. The scale ranges from 1 = never true to 7 always true. Item is scored by adding all of the responses together.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Changes in Living in Alignment With Values: The Valuing Questionnaire (VQ)
The VQ is a 10-item self-report questionnaire with a scale 0 = not true at all to 6 completely true.
Time frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other Pre-specified
Group Therapy Experiences Scale
The 17-item Group Therapy Experiences Scale will be used to assess the level of cohesion among group members (e.g., development of positive relationships, comfort level with other group members). Items 1-16 are rated on a 5-point scale with 1 = strongly agree to 5 = strongly disagree. Item 17 is an open-ended question, was there something in the group today that helped or hindered you?relationships, comfort level with other group members). Items are rated on a 4-point scale with 1= strongly disagree to 4= strongly agree.
Time frame: Following completion of the intervention, up to 12 months