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Completed

NCT Number: NCT05905250

mHealth for Young Adult Cancer Survivors

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University

Washington D.C., District of Columbia, 20052, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Health Education

Behavioral

Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.

Primary outcomes

  1. Retention

    Time frame: 2 months (end-of-treatment; EOT)

    Number of Participants with Retention at End of Treatment

  2. Retention

    Time frame: 4 months (follow-up; FU)

    Number of Participants with Retention at End of Study

  3. Adherence

    Time frame: 2 months (end-of-treatment; EOT)

    Adherence to intervention (number of sessions completed out of 8)

  4. Acceptability

    Time frame: 2 months (end-of-treatment; EOT)

    >75% participants reporting high satisfaction (3 or 4 on scale of 0=not at all to 4=very)

  5. Acceptability

    Time frame: 2 months (end-of-treatment; EOT)

    >75% report yes to "would you recommend this program to your friends who are cancer survivors?"

  6. Hope

    Time frame: 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 outcomes

  1. Hope

    Time frame: 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).

  2. Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale

    Time frame: 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)

  3. Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale

    Time frame: 4 months (follow-up; FU)

    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. Functional Assessment of Cancer Therapy - General (FACT-G)

    Time frame: 2 months (end-of-treatment; EOT)

    Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)

  5. Functional Assessment of Cancer Therapy - General (FACT-G)

    Time frame: 4 months (follow-up; FU)

    Higher scores indicate higher Quality of Life (QOL; scale: 0-108) (https://www.facit.org/measures/fact-g)

  6. Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (2-month)

    Time frame: 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

  7. Depression and Anxiety Symptoms - Mean Patient Reported Outcome Measures for Anxiety and Depression Subscales (4-month)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

An mHealth Positive Psychology Intervention to Reduce Cancer Burden in Young Adult Cancer Survivors

Acronym: mHealthAYA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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