mHealth for Young Adult Cancer Survivors

NCT05905250 | Completed Results DMC

• 2 other identifiers: NCR224269R21CA261884
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Survivorship; Cancer; Psychological Well-Being

Outcome Measures

Primary Outcomes (6)

• 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)

Secondary Outcomes (7)

• Hope

  2 months (end-of-treatment; EOT)

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

  2 months (end-of-treatment; EOT)

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

  4 months (follow-up; FU)

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

  2 months (end-of-treatment; EOT)

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

  4 months (follow-up; FU)

Study Arms (2)

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.

Behavioral: an empirically supported protocol, further refined with evidence-based strategies

Attention Control

ACTIVE COMPARATOR

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

Behavioral: Health education

Interventions

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.

Intervention

Health education BEHAVIORAL

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

Attention Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Completion of curative treatment (surgery, chemotherapy and/or radiation) over three years ago or currently in treatment
• Significant psychological disabilities

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• George Washington University: lead

Study Sites (1)

George Washington University

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

Location

Related Publications (3)

• 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.

  PMID: 41170949 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.

  PMID: 40580382 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.

  PMID: 38657732 DERIVED

MeSH Terms

Conditions

Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Results Point of Contact

• Title: Carla Berg
• Organization: The George Washington University

carlaberg@gwu.edu

202-994-0168

Study Officials

• Carla J Berg, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Prevention and Community Health

Model Details: Individual randomized control trial with 1:1 randomization

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 15, 2023
• Study Start: March 15, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: January 16, 2026
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Locations

US (1)