mHealth for Young Adult Cancer Survivors

Cancer Clinical Trial

— mHealthAYA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905250
• Other study ID #: NCR224269
• Secondary ID: R21CA261884
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: George Washington University
• Contact: Carla J Berg, PhD
• Phone: 4045585395
• Email: carlaberg[@]gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Psychological Well-Being
• Survivorship

Intervention

Behavioral:
• an empirically supported protocol, further refined with evidence-based strategies
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
Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.

Locations

Country	Name	City	State
United States	George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	=>85% retention	2 months (end-of-treatment; EOT)
Primary	Retention	=>85% retention	6-month (follow-up; FU)
Primary	Adherence	>75% adherence to intervention components	2 months (end-of-treatment; EOT)
Primary	Adherence	>75% adherence to intervention components	6-month (follow-up; FU)
Primary	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)
Primary	Acceptability	>75% report yes to "would you recommend this program to your friends who are cancer survivors?"	2 months (end-of-treatment; EOT)
Primary	Hope, per Snyder's Hope Scale	Higher scores indicate higher hope (scale: 6-48)	6-month (follow-up; FU)
Secondary	Hope, per Snyder's Hope Scale	Higher scores indicate higher hope (scale: 6-48)	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 (scale 0-100) (PMCID: PMC2724630)	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 (scale 0-100) (PMCID: PMC2724630)	6-month (follow-up; FU)
Secondary	Quality of Life - Rand Medical Outcome Study 36-Item Short Form Health Survey (SF-36)	Higher scores indicate higher Quality of Life (scale: 0-100) (https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html)	2 months (end-of-treatment; EOT)
Secondary	Quality of Life - Rand Medical Outcome Study 36-Item Short Form Health Survey (SF-36)	Higher scores indicate higher Quality of Life (scale: 0-100) (https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html)	6-month (follow-up; FU)
Secondary	Patient Health Questionnaire - 4 item (PHQ-4): Depression and anxiety symptoms	Higher score indicates greater depressive and anxiety symptoms (scale: 0-12)	2 months (end-of-treatment; EOT)
Secondary	Patient Health Questionnaire - 4 item (PHQ-4): Depression and anxiety symptoms	Higher score indicates greater depressive and anxiety symptoms (scale: 0-12)	6-month (follow-up; FU)
Secondary	Physical activity	Number of days in the past 30 days, engaged in physical activity	2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)
Secondary	Alcohol use	Number of days in the past 30 days, consumed alcohol	2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)
Secondary	Tobacco use	Number of days in the past 30 days, used any tobacco product	2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)
Secondary	Cannabis use	Number of days in the past 30 days, used cannabis	2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)