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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA261884 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Attention Control | Active Comparator | Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| an empirically supported protocol, further refined with evidence-based strategies | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Number of Participants with Retention at End of Treatment | 2 months (end-of-treatment; EOT) |
| Retention | Number of Participants with Retention at End of Study | 4 months (follow-up; FU) |
| Adherence | Adherence to intervention (number of sessions completed out of 8) | 2 months (end-of-treatment; EOT) |
| Acceptability | >75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very) | 2 months (end-of-treatment; EOT) |
| Acceptability | >75% report yes to "would you recommend this program to your friends who are cancer survivors?" | 2 months (end-of-treatment; EOT) |
| 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). | 4 months (follow-up; FU) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 months (end-of-treatment; EOT) |
| Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla J Berg, PhD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170949 | Derived | Berg CJ, McCready DM, Hinds PS, Lyon ME, Dennis K, Howlader A, Bhanot P, Shajan S, Chalasani P, Chitalia A, Arem H. Outcomes of a Randomized Controlled Trial Testing the Feasibility, Acceptability and Preliminary Efficacy of a Digital, Coach-Assisted Intervention to Enhance Hope and Quality of Life Among Young Adult Cancer Survivors. Psychooncology. 2025 Nov;34(11):e70315. doi: 10.1002/pon.70315. | |
| 40580382 | Derived | Berg CJ, Schubel LC, McCready DM, Shajan S, Bhanot P, Dopke C, Howlader A, Hinds PS, Levine J, Lyon ME, Chalasani P, Arem H. Profiles of quality of life among US young adult cancer survivors and their associations with potential psychosocial intervention targets of hope and psychological flexibility. Qual Life Res. 2025 Sep;34(9):2677-2688. doi: 10.1007/s11136-025-04010-0. Epub 2025 Jun 28. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Attention Control | Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention | Number of Participants with Retention at End of Treatment | Posted | Count of Participants | Participants | 2 months (end-of-treatment; EOT) |
|
From enrollment until end of follow-up, up to 20 weeks
This study used the clinicaltrials.gov definition of adverse event and serious adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carla Berg | The George Washington University | 202-994-0168 | carlaberg@gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 18, 2025 | Oct 19, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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Individual randomized control trial with 1:1 randomization
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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.
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| Health education | Behavioral | Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. |
|
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) |
| 2 months (end-of-treatment; EOT) |
| 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) | 4 months (follow-up; FU) |
| 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) | 2 months (end-of-treatment; EOT) |
| 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) | 4 months (follow-up; FU) |
| 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 | 2 months (end-of-treatment; EOT) |
| 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 | 4 months (follow-up; FU) |
| 38657732 | Derived | McCready DM, Arem H, Duarte DA, Dennis K, Ball N, Cafferty LA, Hinds PS, Howlader A, Berg CJ. A digital, coach-assisted intervention to address the psychosocial needs of young adult cancer survivors: Randomized controlled trial protocol and intervention adaptation process. Contemp Clin Trials. 2024 Jun;141:107545. doi: 10.1016/j.cct.2024.107545. Epub 2024 Apr 23. |
| BG001 | Attention Control | Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Sex at birth: female or male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Race, based on NIH/clinicaltrials categories | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | US-based, recruited online | Number | Participants |
|
| 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). | Mean | Standard Deviation | units on a scale |
|
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. |
|
|
| Primary | Retention | Number of Participants with Retention at End of Study | Posted | Count of Participants | Participants | 4 months (follow-up; FU) |
|
|
|
| Primary | Adherence | Adherence to intervention (number of sessions completed out of 8) | Posted | Mean | Standard Deviation | Number of sessions | 2 months (end-of-treatment; EOT) |
|
|
|
| Primary | Acceptability | >75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very) | Analyzed among participants who completed the 2-month survey | Posted | Count of Participants | Participants | 2 months (end-of-treatment; EOT) |
|
|
|
| Primary | Acceptability | >75% report yes to "would you recommend this program to your friends who are cancer survivors?" | Analyzed among participants who completed the 2-month survey | Posted | Count of Participants | Participants | 2 months (end-of-treatment; EOT) |
|
|
|
| Primary | 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). | Analyzed among participants who completed the 4-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 4 months (follow-up; FU) |
|
|
|
| Secondary | 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). | Analyzed among participants who completed the 2-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 2 months (end-of-treatment; EOT) |
|
|
|
| Secondary | 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) | Analyzed among participants who completed the 2-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 2 months (end-of-treatment; EOT) |
|
|
|
| Secondary | 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) | Analyzed among participants who completed the 4-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 4 months (follow-up; FU) |
|
|
|
| Secondary | 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) | Analyzed among participants who completed the 2-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 2 months (end-of-treatment; EOT) |
|
|
|
| Secondary | 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) | Analyzed among participants who completed the 4-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 4 months (follow-up; FU) |
|
|
|
| Secondary | 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 | Analyzed among participants who completed the 2-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 2 months (end-of-treatment; EOT) |
|
|
|
| Secondary | 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 | Analyzed among participants who completed the 4-month survey | Posted | Mean | Standard Deviation | Scores on a scale | 4 months (follow-up; FU) |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Attention Control | Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations. | 0 | 77 | 0 | 77 | 0 | 77 |
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