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2022-07-25
2023-06-15
2023-06-15
8
NCT05131815
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
INTERVENTIONAL
The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors
The purpose of this prospective, interventional, single-arm pilot study is to evaluate whether virtually delivered group-based physical activity is feasible for adolescent and young adult (AYA) cancer survivors. AYAs who were diagnosed with cancer and have completed cancer treatment will be recruited for this study. This study will enroll 20 participants in total and will last approximately 3 months.
This is a single-arm, prospective, interventional pilot study. Adolescent and young adult (AYA) survivors of cancer ages 18-39 (n=20) will engage in three months of virtually group physical activity (PA) delivered via BurnAlong, a wellness platform and online app. Participants will be asked to engage in a BurnAlong workout session with a partner (friend/spouse/child/fellow study participant) a minimum of three times a week for 3 months. Participants will also meet monthly with an exercise physiologist for a customized exercise session. Participants are allowed to engage in additional PA and non-PA sessions on BurnAlong as desired. Participants will also be asked to engage in a private social network discussions around key topics of interest for AYA communities with a focus on post-traumatic growth and positive psychology with a minimum of 2 post engagements a week for 3 months. Participants will complete surveys and physical assessments at baseline and at end of study. Participants also participate in a 1 hr qualitative exit interview about their well-being, participation experiences, and experience with using the BurnAlong platform.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-11-02 | N/A | 2025-02-24 |
2021-11-12 | N/A | 2025-02-26 |
2021-11-23 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Virtual Group-Based Physical Activity (BurnAlong) and Discussion Board Participants will be asked to complete a 12 week virtual physical activity program delivered by the BurnAlong app, participate in a discussion board, and engage in live physical activity sessions with an exercise physiologist. | BEHAVIORAL: Virtual group based physical activity (BurnAlong) and Social Media Discussion Board
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Feasibility of BurnAlong | Number of participants that adhere to a 3-month virtually delivered physical activity program via BurnAlong, group discussion boards, and a monthly live physical activity session with an exercise physiologist | 12 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Resting Heart Rate | Evaluate impact of intervention on resting heart rate (bpm) at 3-months (compared to baseline day 0) | Measured at Baseline and at Week 12 |
| Sleep Duration | Evaluate impact of intervention on sleep duration (number of hours slept each night) at 3-months (compared to baseline day 0) | Measured at Baseline and at Week 12 |
| Sleep Quality | Evaluate impact of intervention on the percentage of time awake during the night at 3-months (compared to baseline day 0) | Measured at Baseline and at Week 12 |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Evaluate short-term effects of virtually delivered exercise, partner support, and group discussion on well-being. PROMIS measures are scored on a T-score metric with a mean of 50 and standard deviation of 10. Scores can be categorized as: within normal limits, mild, moderate and severe. | Measured at Baseline and at Week 12 |
| Post-Traumatic Growth Inventory (PTGI) | Evaluate short-term effects of virtually delivered exercise, partner support, and group discussion on post-traumatic growth and self-improvement | Measured at Baseline and at Week 12 |
| Health Action Process Approach Inventory (HAPA Inventory) | Evaluate short-term effects of virtually delivered exercise, partner support, and group discussion on theoretical determinants of physical activity participation as proposed by the Health Action Process Approach (task self-efficacy, outcome expectancies, risk perception, intentions, planning, maintenance self-efficacy, recovery self-efficacy, physical activity behavior) by comparing data at baseline (day 0) and 3 months | Measured at Baseline and at Week 12 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Social Support | Evaluate short-term effects of virtually delivered exercise, partner support, and group discussion on social well-being. PROMIS measures of the ability to participate in social roles and activities are scored on a T-score metric with a mean of 50 and standard deviation of 10. Scores can be categorized as: within normal limits, mild, moderate and severe. | Measured at Baseline and at Week 12 |
| Adolescent and Young Adult Psycho-Oncology Screening Tool (AYA-POST) | Evaluate short-term effects of virtually delivered exercise, partner support, and group discussion on distress and areas of concern such as practical, family, emotional, social, physical, and information | Measured at Baseline and at Week 12 |
| Measure of Experiential Aspects of Participation (MeEAP) | 12 item questionnaire that assesses the 6 experiential aspects of participation (autonomy, belongingness, challenge, engagement, mastery, and meaning) on a 7 point scale (1, strongly disagree, to 7, strongly agree) | Measured at Baseline and at Week 12 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
