Cancer Clinical Trial
Official title:
Promoting Quality of Life Among Young Adult Cancer Survivors
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).
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).
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