Promoting Quality of Life Among Young Adult Cancer Survivors
Condition: Cancer
Study type: Interventional

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).
    

Intervention name(s): App-based behavioral intervention; Attention control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Achieving Wellness After Kancer in Early life (AWAKE) is a behavioral intervention that includes a smartphone app and coaching. AWAKE contains eight modules, and participants will complete the one module every week. App functioning will facilitate weekly homework assignments and include health education messaging, the ability to track progress toward goals over time via self-monitoring and graphical depictions of progress, audio-recordings of guided imagery exercises and relaxation exercises (e.g., progressive muscle relaxation), videos of topic-related inspirational material, and a portal for interacting with the coach. The coach will call each intervention participant weekly. Each coaching session will last roughly 30 minutes and involve four segments that will correspond to the module for the week. The coach will send daily text messages to participants encouraging their goal pursuits and providing other sources of support related to that week's homework.; The attention control group will receive the same components as the intervention group, but the educational modules will contain different content than those receiving the AWAKE intervention.
Other intervention name(s): AWAKE
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer survivor; App-based intervention; Behavioral intervention