Clinical trial NCT05905250: mHealth for Young Adult Cancer Survivors
Official title: An mHealth Positive Psychology Intervention to Reduce Cancer Burden in Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Cancer
Psychological Well-Being
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-06-15
Enrollment: 155
Sex: ALL
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual randomized control trial with 1:1 randomization
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Retention
timeFrame: 2 months (end-of-treatment; EOT)
measure: Retention
timeFrame: 6-month (follow-up; FU)
measure: Adherence
timeFrame: 2 months (end-of-treatment; EOT)
measure: Adherence
timeFrame: 6-month (follow-up; FU)
measure: Acceptability
timeFrame: 2 months (end-of-treatment; EOT)
measure: Acceptability
timeFrame: 2 months (end-of-treatment; EOT)
measure: Hope, per Snyder's Hope Scale
timeFrame: 6-month (follow-up; FU)
Secondary outcomes:
measure: Hope, per Snyder's Hope Scale
timeFrame: 2 months (end-of-treatment; EOT)
measure: Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health scale
timeFrame: 2 months (end-of-treatment; EOT)
measure: Quality of Life - Patient-Reported Outcome Measurement Information System (PROMIS) Global Health scale
timeFrame: 6-month (follow-up; FU)
measure: Quality of Life - Rand Medical Outcome Study 36-Item Short Form Health Survey (SF-36)
timeFrame: 2 months (end-of-treatment; EOT)
measure: Quality of Life - Rand Medical Outcome Study 36-Item Short Form Health Survey (SF-36)
timeFrame: 6-month (follow-up; FU)
measure: Patient Health Questionnaire - 4 item (PHQ-4): Depression and anxiety symptoms
timeFrame: 2 months (end-of-treatment; EOT)
measure: Patient Health Questionnaire - 4 item (PHQ-4): Depression and anxiety symptoms
timeFrame: 6-month (follow-up; FU)
measure: Physical activity
timeFrame: 2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)
measure: Alcohol use
timeFrame: 2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)
measure: Tobacco use
timeFrame: 2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)
measure: Cannabis use
timeFrame: 2 months (end-of-treatment; EOT) and 6-month (follow-up; FU)
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Carla J Berg, PhD
role: PRINCIPAL_INVESTIGATOR
References: