Clinical trial NCT03564587: Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial
Official title: Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Cancer Survivors
Adolescent
Achieving Wellness After Kancer in Early Life
AWAKE
Health-Promoting Behaviors
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 92
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in the he Children's Hope Scale score
timeFrame: Baseline, 2 and 4 months follow up visits
Secondary outcomes:
measure: Change in the Pediatric Quality of Life Inventory (PedsQL), 4.0 scale score
timeFrame: Baseline, 2 and 4 months follow up visits
measure: Change in number of servings of fruits and vegetables
timeFrame: Baseline, 2 and 4 months follow up visits
measure: Change in number of physical activity hours per day
timeFrame: Baseline, 2 and 4 months follow up visits
measure: Change in number of screen time hours per day
timeFrame: Baseline, 2 and 4 months follow up visits
measure: Change in PROMIS score
timeFrame: Baseline, 2 and 4 months follow up visits
measure: Usability of AWAKE
timeFrame: 2 month assessment
measure: Satisfaction with AWAKE
timeFrame: 2 month assessment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Karen Effinger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: