Health BehaviorCHOA AWAKENCT03564587
Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial
A study testing AWAKE in people with Health Behavior, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- AWAKE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2018to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Cognitive delay that would preclude participation
- Participant or designated guardian unable to read English
- Active disease relapse
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
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. 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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- AWAKE
- Keywords
- Cancer Survivors, Adolescent, Achieving Wellness After Kancer in Early Life, AWAKE, Health-Promoting Behaviors
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWAKEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 and 4 months follow up visits
Secondary outcomes (7)
Change in the Pediatric Quality of Life Inventory (PedsQL), 4.0 scale score
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).
Measured: Baseline, 2 and 4 months follow up visits
Change in number of servings of fruits and vegetables
Change in number of servings of fruits and vegetables will be assessed using 9 dietary habits questions from Risk Behavior Surveillance System (YRBSS) survey
Measured: Baseline, 2 and 4 months follow up visits
Change in number of physical activity hours per day
Change in number of physical activity hours per day will be assessed using 5 physical activity questions from Risk Behavior Surveillance System (YRBSS) survey
Measured: Baseline, 2 and 4 months follow up visits
Change in number of screen time hours per day
Change in number of screen time hours per day will be will be assessed using a question from Risk Behavior Surveillance System (YRBSS) survey
Measured: Baseline, 2 and 4 months follow up visits
Change in PROMIS score
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
Measured: Baseline, 2 and 4 months follow up visits
Usability of AWAKE
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.
Measured: 2 month assessment
Satisfaction with AWAKE
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.
Measured: 2 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start20 Jun 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Effinger, Emory University
- Investigators
- Karen Effinger, MD, MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564587
- Sponsor's protocol ID
- IRB00099050
- Acronym
- CHOA AWAKE
- Status last verified
- Dec 2021
- First submitted
- 11 Jun 2018
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health-Promoting Behaviors in Adolescent Cancer Survivors Using AWAKE: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT03564587
- Acronym / sponsor ID
- CHOA AWAKE / IRB00099050
- Conditions
- Health Behavior
- Keywords
- Cancer Survivors, Adolescent, Achieving Wellness After Kancer in Early Life, AWAKE, Health-Promoting Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AWAKE | Experimental | Behavioral: AWAKEThe 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. |
| 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive delay that would preclude participation
- Participant or designated guardian unable to read English
- Active disease relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWAKEBehavioral 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. | Behavioural | AWAKE |
Primary outcome
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.
7 secondary outcomes
Change in the Pediatric Quality of Life Inventory (PedsQL), 4.0 scale score
Time frame: Baseline, 2 and 4 months follow up visits
Change in number of servings of fruits and vegetables
Time frame: Baseline, 2 and 4 months follow up visits
Change in number of physical activity hours per day
Time frame: Baseline, 2 and 4 months follow up visits
Change in number of screen time hours per day
Time frame: Baseline, 2 and 4 months follow up visits
Change in PROMIS score
Time frame: Baseline, 2 and 4 months follow up visits
Usability of AWAKE
Time frame: 2 month assessment
Satisfaction with AWAKE
Time frame: 2 month assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Effinger, MD, MS principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWAKE in people with Health Behavior, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the he Children's Hope Scale score (time frame: Baseline, 2 and 4 months follow up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.