AWAKE Mobile Application and Coaching Phone Calls in Improving Health-Promoting Behaviors in Adolescent Cancer Survivors and Their Guardians

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Solid Tumor	NCT ID:	NCT03564587
Trial Phases:		Protocol IDs:	CHOA4223-17 (primary) NCI-2018-00736 IRB00099050
Eligibility:	13 - 17 Years, Male and Female	Study Type:	Supportive care
Study Sponsor:	Children's Healthcare of Atlanta - Egleston
NCI Full Details:	http://clinicaltrials.gov/show/NCT03564587

Summary

This trial studies how well the AWAKE mobile application and coaching phone calls work in improving health-promoting behaviors in adolescent cancer survivors and their guardians. AWAKE mobile application and phone-based coaching may help participants with goal setting, and improve quality of life and healthy behaviors.

Objectives

PRIMARY OBJECTIVES:
I. Assess the feasibility and acceptability of an adapted Achieving Wellness After Kancer in Early Life (AWAKE) intervention for adolescent cancer survivors and their guardians.
II. Estimate effect sizes of the AWAKE intervention in relation to the primary outcome of hope and secondary outcomes of quality of life and participation in health-promoting behaviors in adolescent cancer survivors at the end of the intervention (2 months) and at 4 months to inform sample size calculations for an efficacy trial.
III. Examine characteristics of patients that predict increased hope, quality of life, and participation in health promoting behaviors after the AWAKE intervention.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants use the AWAKE mobile application to view educational materials and complete homework assignments and receive weekly coaching phone calls over 15-30 minutes for 8 weeks.

GROUP II: Participants complete surveys.

After completion of study, participants are followed up at 4 months.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.