NCT05905250: mHealthAYA

mHealth for Young Adult Cancer Survivors

Completed NA Results posted Last updated 16 January 2026

What this trial tests

NA trial testing an empirically supported protocol, further refined with evidence-based strategies in Survivorship in 155 participants. Completed in 28 February 2025.

Timeline

15 March 2024

Primary endpoint
28 February 2025

28 February 2025

Quick facts

Lead sponsor	George Washington University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	155
Start date	15 March 2024
Primary completion	28 February 2025
Estimated completion	28 February 2025
Sites	1 location across United States

Drugs / interventions tested

• an empirically supported protocol, further refined with evidence-based strategies
• Health education

Conditions studied

• Survivorship — all drugs for Survivorship →
• Cancer — all drugs for Cancer →
• Psychological Well-Being — all drugs for Psychological Well-Being →

Sponsor

George Washington University

Who can join

Adults 18 to 39, any sex, with Survivorship or Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention Primary · 2 months (end-of-treatment; EOT)

Number of Participants with Retention at End of Treatment

Group	Value	95% CI
Intervention	74	70 – 78
Attention Control	72	68 – 76

Retention Primary · 4 months (follow-up; FU)

Number of Participants with Retention at End of Study

Group	Value	95% CI
Intervention	75
Attention Control	72

Adherence Primary · 2 months (end-of-treatment; EOT)

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

Group	Value	95% CI
Intervention	7.0	6 – 8
Attention Control	7.3	6 – 8

Acceptability Primary · 2 months (end-of-treatment; EOT)

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

Group	Value	95% CI
Intervention	57
Attention Control	43

Acceptability Primary · 2 months (end-of-treatment; EOT)

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

Group	Value	95% CI
Intervention	67
Attention Control	60

Hope Primary · 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).

Group	Value	95% CI
Intervention	50.15	± 7.94
Attention Control	51.11	± 8.35

Hope Secondary · 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).

Group	Value	95% CI
Attention Control	50.78	± 8.32
Intervention	49.82	± 8.60

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

Group	Value	95% CI
Intervention	51.72	± 3.75
Attention Control	51.38	± 3.40

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

Group	Value	95% CI
Intervention	51.17	± 3.50
Attention Control	51.56	± 3.10

Functional Assessment of Cancer Therapy - General (FACT-G) Secondary · 2 months (end-of-treatment; EOT)

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

Group	Value	95% CI
Intervention	77.49	± 17.52
Attention Control	80.17	± 15.87

Functional Assessment of Cancer Therapy - General (FACT-G) Secondary · 4 months (follow-up; FU)

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

Group	Value	95% CI
Intervention	79.18	± 11.37
Attention Control	79.15	± 10.41

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

Group	Value	95% CI
Intervention	53.62	± 8.69
Attention Control	52.68	± 7.90

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A digital, coach-assisted intervention to address the psychosocial needs of young adult cancer survivors: Randomized controlled trial protocol and intervention adaptation process.
   McCready DM, Arem H, Duarte DA, Dennis K, et al · · 2024 · cited 2× · PMID 38657732 · DOI 10.1016/j.cct.2024.107545
2. 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.
   Berg CJ, McCready DM, Hinds PS, Lyon ME, et al · · 2025 · PMID 41170949 · DOI 10.1002/pon.70315
3. Profiles of quality of life among US young adult cancer survivors and their associations with potential psychosocial intervention targets of hope and psychological flexibility.
   Berg CJ, Schubel LC, McCready DM, Shajan S, et al · · 2025 · PMID 40580382 · DOI 10.1007/s11136-025-04010-0