Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial

NCT03564587 | Completed

• 1 other identifier: IRB00099050
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

A behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. The goals of this project are to adapt the AWAKE platform into an intervention acceptable for use in adolescent cancer survivors and their guardians in order to improve survivors' hope, quality of life, and health-promoting behaviors, and to generate the preliminary data needed for a randomized control trial to test the efficacy of the AWAKE platform in this population.

Conditions

Health Behavior

Keywords

Cancer Survivors; Adolescent; Achieving Wellness After Kancer in Early Life; AWAKE; Health-Promoting Behaviors

Outcome Measures

Primary Outcomes (1)

• Change in the he Children's Hope Scale score

  A 6-item self-report questionnaire assessing children's dispositional hope. Two components, agency (ability to initiate and sustain action towards goals) and pathways (capacity to find a means to carry out goals), are assessed by the measure. Responses are on a 6-point Likert-scale ranging from 1=none of the time to 6=all of the time with higher scores representing increased dispositional hope.

  Baseline, 2 and 4 months follow up visits

Secondary Outcomes (7)

• Change in the Pediatric Quality of Life Inventory (PedsQL), 4.0 scale score

  Baseline, 2 and 4 months follow up visits

• Change in number of servings of fruits and vegetables

  Baseline, 2 and 4 months follow up visits

• Change in number of physical activity hours per day

  Baseline, 2 and 4 months follow up visits

• Change in number of screen time hours per day

  Baseline, 2 and 4 months follow up visits

• Change in PROMIS score

  Baseline, 2 and 4 months follow up visits

Study Arms (2)

AWAKE

EXPERIMENTAL

The AWAKE intervention is an 8 week program including a mobile app and phone-based coaching, focused on improving hope in order to increase quality of life and health-promoting behaviors in young adult cancer survivors.

Behavioral: AWAKE

No treatment

NO INTERVENTION

Control participants will receive the surveys to complete only; however, they may opt to receive the intervention after the 4-month assessment.

Interventions

AWAKE BEHAVIORAL

Behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) is focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. The AWAKE mobile app contains eight modules for participants to complete over 8 weeks with the ability to review prior modules. Participants receive a prompt on their mobile device weekly to complete each module and/or they will receive a text reminder. The app includes health education messaging, weekly homework assignments, the ability to track progress towards goals with self-monitoring and graphical depictions of progress, videos of inspirational materials, and a portal for interacting with their coach.

AWAKE

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescent survivors:
• Early survivor: 3 months to 2 years after therapy completion
• Long-term survivor: ≥2 years after therapy completion
• years of age
• Access to tablet or smartphone and internet
• One designated guardian per survivor

You may not qualify if:

• Cognitive delay that would preclude participation
• Participant or designated guardian unable to read English
• Active disease relapse

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Karen Effinger, MD, MS

  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: Assistant Professor

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: June 20, 2018
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

US (1)