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

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Behavioral: AWAKE

• Registration Number: NCT03564587
• Lead Sponsor: Emory University

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.

Detailed Description

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. Adaptation of this intervention to incorporate messaging for adolescents and their guardians has the potential to have a long-term impact on adolescent cancer survivors. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study Start: 2018-06-20
• Study First Posted: 2018-06-21
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Adolescent survivors:

• Early survivor: 3 months to 2 years after therapy completion
• Long-term survivor: ≥2 years after therapy completion
• 13-17 years of age
• Access to tablet or smartphone and internet

One designated guardian per survivor

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AWAKE	AWAKE	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.

Primary Outcome Measures

Name	Time	Method
Change in the he Children's Hope Scale score	Baseline, 2 and 4 months follow up visits	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.

Secondary Outcome Measures

Name	Time	Method
Change in number of physical activity hours per day	Baseline, 2 and 4 months follow up visits	Change in number of physical activity hours per day will be assessed using 5 physical activity questions from Risk Behavior Surveillance System (YRBSS) survey
Change in the Pediatric Quality of Life Inventory (PedsQL), 4.0 scale score	Baseline, 2 and 4 months follow up visits	The PedsQL 4.0 scale has 23-items that are grouped into four domains: 1)Physical Functioning (eight items), 2) Emotional Functioning (five items), 3) Social Functioning (five items) and 4) School Functioning (five items). 5-point response scale is utilized across child self-report and parent proxy-report (0 never a problem; 1 almost never a problem; 2 sometimes a problem; 3 often a problem; 4 almost always a problem). Subjects are requested to rate how much problems they experienced during the past month. All items are reverse-scored and linearly transformed to a 0 100 scale (0 100, 1 75, 2 50, 3 25, 4 0), so that higher scores indicate better Health-related quality of life (HRQoL).
Change in number of servings of fruits and vegetables	Baseline, 2 and 4 months follow up visits	Change in number of servings of fruits and vegetables will be assessed using 9 dietary habits questions from Risk Behavior Surveillance System (YRBSS) survey
Change in number of screen time hours per day	Baseline, 2 and 4 months follow up visits	Change in number of screen time hours per day will be will be assessed using a question from Risk Behavior Surveillance System (YRBSS) survey
Change in PROMIS score	Baseline, 2 and 4 months follow up visits	The PROMIS Peer Relationships, Anxiety, and Depression scales have self-report and parent-proxy versions. Each scale is scored from 0-100 with higher scores indicating better peer relationships, worse anxiety and worse depression. Questions: 8 peer relationships, 8 anxiety, 8 depression
Usability of AWAKE	2 month assessment	Responses to four usability questions will be based on a 5-point Likert scale (1=very useless/ineffective; 5=very useful/effective) with higher ratings indicating more favorable attitudes.
Satisfaction with AWAKE	2 month assessment	Responses to 16 satisfaction questions will be based on a 5-point Likert scale (1=very useless/ineffective; 5=very useful/effective) with higher ratings indicating more favorable attitudes.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States