Cancer, Psychological Well-Being, Survivorship
Conditions
Brief summary
We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized controlled trial (RCT) of the intervention vs. attention control among 150 YA cancer survivors. The proposed research is innovative in its use of: 1) a novel intervention target - hope - as a mechanism for addressing goal-disruption and quality of life (QOL) among YA survivors; and 2) novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare. This proposal has potential high impact due to the number of YA cancer survivors for whom the intervention may be relevant, the intervention's potential utility in enhancing hope and QOL among YAs, and its reach/scalability.
Detailed description
Young adulthood (YA) is a critical time in shaping life trajectories related to educational, financial, and family goals, among others. Unfortunately, cancer diagnosis/treatment and its psychosocial sequelae disrupt this critical period for some YAs. This life goal disturbance is related to poorer psychological outcomes, particularly among YAs; however, goal revision and reprioritization lead to more positive psychological outcomes. Thus, goal negotiation is a critical part of survivorship. Understanding psychosocial determinants of positive psychological and behavioral outcomes is critical for developing effective behavioral interventions. Within the rich positive psychology literature, the construct of hope is one particularly relevant factor for YA cancer survivors; hope has been defined as a positive cognitive state based on a sense of successful goal-directed determination and planning to meet these goals. In the general population and in cancer survivors, hope is related to better quality of life (QOL), mental health, health behaviors, and coping with illness/cancer. Our team pioneered an mHealth intervention (i.e., app-based with phone-based counseling) aimed at increasing hope among YA survivors, thereby re-engaging them in long-term life goals across domains (e.g., vocational, familial) and ultimately increasing QOL. In an 8-week pilot randomized controlled trial (RCT) of 56 YAs recruited from 2 cancer centers, the intervention demonstrated feasibility (95% retention), acceptability (e.g., high satisfaction), and promising trends in changes in hope, QOL, depressive symptoms, and health behaviors (e.g., substance use) in YA survivors. This study builds on our prior work to update the intervention (e.g., its technology), enhance its reach, and increase our ability to examine its effects. Our specific aims are to: 1) conduct formative research examining YA cancer survivor preferences on phone-based counseling with app support to enhance the intervention; and 2) test the feasibility, acceptability, and preliminary efficacy of the intervention vs. attention control (AC) via an 8-week RCT of 150 YA cancer survivors. The proposed research is innovative in its use of a novel intervention target - hope - as a mechanism for addressing goal-disruption and QOL among YA survivors, and its use of novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare.
Interventions
The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
Sponsors
Study design
Masking description
The investigative team will be masked except in the event interventionists or data collectors require input from the team that requires disclosure of identifying information. Participants will be randomized to the intervention or attention control.
Intervention model description
Individual randomized control trial with 1:1 randomization
Eligibility
Inclusion criteria
* Diagnosis of stage I-IV cancer from age 18-39 * Completion of curative treatment (surgery, chemotherapy and/or radiation) within three years of study enrollment * No significant psychological disabilities * Able to complete forms and understand instructions in English * Smartphone access * Aim 2: Able to commit to 8-week remotely delivered study
Exclusion criteria
* Completion of curative treatment (surgery, chemotherapy and/or radiation) over three years ago or currently in treatment * Significant psychological disabilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 2 months (end-of-treatment; EOT) | Number of Participants with Retention at End of Treatment |
| Adherence | 2 months (end-of-treatment; EOT) | Adherence to intervention (number of sessions completed out of 8) |
| Acceptability | 2 months (end-of-treatment; EOT) | \>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very) |
| Hope | 4 months (follow-up; FU) | Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hope | 2 months (end-of-treatment; EOT) | Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome). |
| Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale | 2 months (end-of-treatment; EOT) | Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean scores across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression) |
| Functional Assessment of Cancer Therapy - General (FACT-G) | 2 months (end-of-treatment; EOT) | Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g) |
| Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month) | 2 months (end-of-treatment; EOT) | Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales |
| Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month) | 4 months (follow-up; FU) | Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales |
Countries
United States
Contacts
George Washington University
Participant flow
Recruitment details
This study focuses on young adult (YA) cancer survivors, targeting \ 150 participants total enrolled. Inclusion criteria included: 18-39 years old, within 3 years of completing primary treatment or on maintenance chemotherapy, English-speaking, US resident, and smartphone access.
Pre-assignment details
Participants were recruited, screened for eligibility, consented, and asked to complete the baseline survey. Both AWARE and the AC involved an 8-week intervention and control for non-specific intervention components.
Participants by arm
| Arm | Count |
|---|---|
| Intervention The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature. | 78 |
| Attention Control Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. | 77 |
| Total | 155 |
Baseline characteristics
| Characteristic | Total | Attention Control | Intervention |
|---|---|---|---|
| Age, Continuous | 32.89 Years STANDARD_DEVIATION 4.86 | 32.82 Years STANDARD_DEVIATION 4.79 | 32.96 Years STANDARD_DEVIATION 5.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants | 73 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hope | 49.41 units on a scale STANDARD_DEVIATION 8.55 | 50.09 units on a scale STANDARD_DEVIATION 8.03 | 48.74 units on a scale STANDARD_DEVIATION 9.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 8 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 3 Participants | 6 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 120 Participants | 62 Participants | 58 Participants |
| Region of Enrollment United States | 155 Participants | 77 Participants | 78 Participants |
| Sex: Female, Male Female | 136 Participants | 67 Participants | 69 Participants |
| Sex: Female, Male Male | 19 Participants | 10 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 77 |
| other Total, other adverse events | 0 / 78 | 0 / 77 |
| serious Total, serious adverse events | 0 / 78 | 0 / 77 |
Outcome results
Acceptability
\>75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)
Time frame: 2 months (end-of-treatment; EOT)
Population: Analyzed among participants who completed the 2-month survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Acceptability | 57 Participants |
| Attention Control | Acceptability | 43 Participants |
Acceptability
\>75% report yes to would you recommend this program to your friends who are cancer survivors?
Time frame: 2 months (end-of-treatment; EOT)
Population: Analyzed among participants who completed the 2-month survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Acceptability | 67 Participants |
| Attention Control | Acceptability | 60 Participants |
Adherence
Adherence to intervention (number of sessions completed out of 8)
Time frame: 2 months (end-of-treatment; EOT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Adherence | 7.0 Number of sessions | Standard Deviation 2 |
| Attention Control | Adherence | 7.3 Number of sessions | Standard Deviation 1.8 |
Hope
Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).
Time frame: 4 months (follow-up; FU)
Population: Analyzed among participants who completed the 4-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Hope | 50.15 Scores on a scale | Standard Deviation 7.94 |
| Attention Control | Hope | 51.11 Scores on a scale | Standard Deviation 8.35 |
Retention
Number of Participants with Retention at End of Treatment
Time frame: 2 months (end-of-treatment; EOT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Retention | 74 Participants |
| Attention Control | Retention | 72 Participants |
Retention
Number of Participants with Retention at End of Study
Time frame: 4 months (follow-up; FU)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Retention | 75 Participants |
| Attention Control | Retention | 72 Participants |
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)
Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales
Time frame: 2 months (end-of-treatment; EOT)
Population: Analyzed among participants who completed the 2-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month) | 53.62 Scores on a scale | Standard Deviation 8.69 |
| Attention Control | Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month) | 52.68 Scores on a scale | Standard Deviation 7.9 |
Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)
Higher scores indicate lower anxiety and depressive symptoms (scale 0-100); mean score of across anxiety and depressive symptom subscales
Time frame: 4 months (follow-up; FU)
Population: Analyzed among participants who completed the 4-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month) | 52.05 Scores on a scale | Standard Deviation 8.71 |
| Attention Control | Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month) | 53.04 Scores on a scale | Standard Deviation 8.13 |
Functional Assessment of Cancer Therapy - General (FACT-G)
Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)
Time frame: 2 months (end-of-treatment; EOT)
Population: Analyzed among participants who completed the 2-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Functional Assessment of Cancer Therapy - General (FACT-G) | 77.49 Scores on a scale | Standard Deviation 17.52 |
| Attention Control | Functional Assessment of Cancer Therapy - General (FACT-G) | 80.17 Scores on a scale | Standard Deviation 15.87 |
Functional Assessment of Cancer Therapy - General (FACT-G)
Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)
Time frame: 4 months (follow-up; FU)
Population: Analyzed among participants who completed the 4-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Functional Assessment of Cancer Therapy - General (FACT-G) | 79.18 Scores on a scale | Standard Deviation 11.37 |
| Attention Control | Functional Assessment of Cancer Therapy - General (FACT-G) | 79.15 Scores on a scale | Standard Deviation 10.41 |
Hope
Hope, per Snyder's Adult Hope Scale - a 12-item measure, each scored on a 1-8 scale; 8 items assess hope-related factors (4 are distractor/filler items), for a total score range of 8-64. Higher scores indicate higher hope (better outcome).
Time frame: 2 months (end-of-treatment; EOT)
Population: Analyzed among participants who completed the 2-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Hope | 50.78 Scores on a scale | Standard Deviation 8.32 |
| Attention Control | Hope | 49.82 Scores on a scale | Standard Deviation 8.6 |
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean scores across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)
Time frame: 2 months (end-of-treatment; EOT)
Population: Analyzed among participants who completed the 2-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale | 51.72 Scores on a scale | Standard Deviation 3.75 |
| Attention Control | Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale | 51.38 Scores on a scale | Standard Deviation 3.4 |
Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Higher scores indicate higher Quality of Life (QOL; scale 0-100) (PMCID: PMC2724630); mean score across QOL dimensions (physical functioning, social functioning, pain interference, fatigue, sleep disturbance, anxiety, depression)
Time frame: 4 months (follow-up; FU)
Population: Analyzed among participants who completed the 4-month survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale | 51.17 Scores on a scale | Standard Deviation 3.5 |
| Attention Control | Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale | 51.56 Scores on a scale | Standard Deviation 3.1 |