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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03564587
Acronym
CHOA AWAKE
Enrollment
92
Registered
2018-06-21
Start date
2018-06-20
Completion date
2020-09-15
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

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

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.

Interventions

BEHAVIORALAWAKE

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.

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the he Children's Hope Scale scoreBaseline, 2 and 4 months follow up visitsA 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

MeasureTime frameDescription
Change in number of servings of fruits and vegetablesBaseline, 2 and 4 months follow up visitsChange 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 physical activity hours per dayBaseline, 2 and 4 months follow up visitsChange 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 number of screen time hours per dayBaseline, 2 and 4 months follow up visitsChange 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 the Pediatric Quality of Life Inventory (PedsQL), 4.0 scale scoreBaseline, 2 and 4 months follow up visitsThe 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).
Usability of AWAKE2 month assessmentResponses 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 AWAKE2 month assessmentResponses 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.
Change in PROMIS scoreBaseline, 2 and 4 months follow up visitsThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026