Promoting Quality of Life Among Young Adult Cancer Survivors

NCT03446105 | Completed

• 1 other identifier: IRB00086979
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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).

Conditions

Cancer

Keywords

Cancer survivor; App-based intervention; Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Change in Adult Trait Hope Scale Score

  The Adult Trait Hope Scale is a 12-item survey where respondents indicate how true a statement is on a scale of 1 (definitely false) to 8 (definitely true). The Hope Scale includes two subscales of four items each plus four distracter items. Higher scores on the Pathways subscale (example question: "I can think of many ways to get out of a jam") indicate higher levels of pathways thinking. Higher scores on the Agency subscale (example question: "I energetically pursue my goals") indicate higher levels of agency thinking. The subscales will be summed to obtain a total hope score. Total scores can range from 8 to 64 with higher scores indicating higher levels of hope.

  Baseline, Month 2, Month 6

Secondary Outcomes (2)

• Change in 36-Item Short Form Health Survey (SF-36) Score

  Baseline, Month 2, Month 6

• Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score

  Baseline, Month 2, Month 6

Other Outcomes (4)

• Participation rate

  Baseline

• Retention rate

  Month 2, Month 6

• Use of AWAKE

  Month 2

Study Arms (2)

App-based behavioral intervention

EXPERIMENTAL

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

Behavioral: App-based behavioral intervention

Attention control group

ACTIVE COMPARATOR

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

Behavioral: Attention control group

Interventions

App-based behavioral intervention 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.

Also known as: AWAKE

App-based behavioral intervention

Attention control group 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.

Attention control group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Carla Berg, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 26, 2018
• Study Start: February 9, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

US (2)