Promoting Quality of Life Among Young Adult Cancer Survivors

NCT ID: NCT03446105

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-09
• Study Completion Date: 2018-07-31

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).

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

App-based behavioral intervention

Participants randomized to this study arm will take part in the Achieving Wellness After Kancer in Early life (AWAKE) behavioral intervention for 8 weeks.

Group Type: EXPERIMENTAL

App-based behavioral intervention

Intervention Type: BEHAVIORAL

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.

Attention control group

Participants randomized to this study arm will take part in a behavioral intervention and coaching for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Attention control group

Intervention Type: BEHAVIORAL

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.

Interventions

App-based behavioral intervention

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.

Intervention Type: BEHAVIORAL

Attention control group

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

AWAKE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Carla Berg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla Berg, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Markey Cancer Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

IRB00086979

Identifier Type: -

Identifier Source: org_study_id