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Completed

NCT Number: NCT03564587

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

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.

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Key information

Conditions

Health Behavior Behavior

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in the he Children's Hope Scale score

    Time frame: 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 outcomes

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

    Time frame: 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).

  2. Change in number of servings of fruits and vegetables

    Time frame: 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

  3. Change in number of physical activity hours per day

    Time frame: 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

  4. Change in number of screen time hours per day

    Time frame: 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

  5. Change in PROMIS score

    Time frame: 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

  6. Usability of AWAKE

    Time frame: 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.

  7. Satisfaction with AWAKE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Acronym: CHOA AWAKE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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