mHealth for Young Adult Cancer Survivors

Trial Title: mHealth for Young Adult Cancer Survivors

NCT ID: NCT05905250

Condition: Survivorship
Cancer
Psychological Well-Being

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Individual randomized control trial with 1:1 randomization

Primary purpose: Supportive Care

Masking: Double (Participant, Outcomes Assessor)

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:

Intervention type: Behavioral
Intervention name: an empirically supported protocol, further refined with evidence-based strategies
Description: 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.
Arm group label: Intervention

Intervention type: Behavioral
Intervention name: Health education
Description: Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.
Arm group label: Attention Control

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Diagnosis of stage I-IV cancer from age 20-39 - 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

Gender: All

Minimum age: 20 Years

Maximum age: 39 Years

Healthy volunteers: No

Locations:

Facility:
Name: George Washington University

Address:
City: Washington
Zip: 20052
Country: United States

Status: Recruiting

Contact:
Last name: Carla J Berg, PhD

Phone: 404-558-5395
Email: carlaberg@gwu.edu

Start date: March 15, 2024

Completion date: December 31, 2024

Lead sponsor:
Agency: George Washington University
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: George Washington University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05905250