Clinical trial NCT03446105: Promoting Quality of Life Among Young Adult Cancer Survivors
Official title: Promoting Quality of Life Among Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer survivor
App-based intervention
Behavioral intervention
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned (stratified by age and sex) to one of the treatment conditions in a 2:1 ratio (2 to intervention: 1 to attention control).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study expands on a prior pilot study to refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the intervention to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two National Cancer Institute (NCI)-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). Participants will be randomly assigned (stratified by age and sex) to one of the 8-week treatment conditions in a 2:1 ratio (2 to intervention: 1 to attention control).

Detailed description: Young adulthood is a critical time for negotiating several life transitions and establishing and pursuing important life goals. Unfortunately, a cancer diagnosis disrupts this period of life for more than 60,000 people annually in the U.S. Compared to those without a history of cancer, young adult cancer survivors report poorer mental and physical health; moreover, they report significantly greater disruption in their goal pursuits than cancer survivors diagnosed at a later age. However, this high-risk group has been underserved and understudied, particularly in terms of intervention research to address these sequelae. Hope, a positive psychology construct that taps the ways in which people choose and pursue goals, is particularly relevant to this population. Additionally, higher hope is related to engaging in health promoting behaviors and living healthier lifestyles, which reduces risk of disease and adverse late effects and ultimately increase quality of life (QOL). The research team has pioneered a app-based behavioral intervention called Achieving Wellness After Kancer in Early life (AWAKE), aimed at promoting healthy lifestyles - specifically targeting mental health and positive health behaviors - among young adult cancer survivors. The proposed study will refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the prior pilot work to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two NCI-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). In this randomized controlled trial, recipients of the AWAKE intervention will be compared to an attention control group.

The specific aims of this study are to:

Aim 1. Test the feasibility and acceptability of AWAKE among intervention participants. The primary feasibility indicators are participation rates and retention rates. The primary acceptability indicators are use of and satisfaction with intervention components.

Aim 2. Estimate effect sizes of AWAKE vs. control at 2 and 6 months to inform sample size calculations for the subsequent efficacy trial. The primary outcome is changes in hope, per the Trait Hope Scale. The secondary outcome is changes in quality of life, per the 36-Item Short Form Health Survey (SF-36) and the Functional Assessment of Cancer Therapy - General (FACT-G).

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 39, as of January 15th, 2017
* Speak English
* Be within two years of cancer treatment completion (since January 15th, 2015)
* Have a functioning smartphone and reliable internet access
* Be willing to complete study activities

Exclusion Criteria:

* Cancer recurrence since treatment completion
* Diagnosis of a central nervous system cancer (to ensure requisite mental/emotional functioning to engage in the program)
* Diagnosis of a thyroid cancer
* History of alcohol or drug dependency in the past year, or psychosis, bipolar disorder, or major depressive disorder
* In hospice

Primary outcomes:
measure: Change in Adult Trait Hope Scale Score
timeFrame: Baseline, Month 2, Month 6
Secondary outcomes:
measure: Change in 36-Item Short Form Health Survey (SF-36) Score
timeFrame: Baseline, Month 2, Month 6
measure: Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
timeFrame: Baseline, Month 2, Month 6
Other outcomes:
measure: Participation rate
timeFrame: Baseline
measure: Retention rate
timeFrame: Month 2, Month 6
measure: Use of AWAKE
timeFrame: Month 2
measure: Satisfaction with AWAKE
timeFrame: Month 2
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
Study officials:
affiliation: Emory University
name: Carla Berg, PhD
role: PRINCIPAL_INVESTIGATOR
References: