Breast Cancer Clinical Trial
Official title:
The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention for Adolescent and Young Adult Cancer Survivors
Verified date | June 2024 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 8 |
Est. completion date | January 21, 2025 |
Est. primary completion date | July 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - Cancer (all types) diagnosis between the ages of 15-39 - Between the ages of 18-39 during study participation - At least 3 months post-active treatment completion - Answers "no" to all questions on the Physical Activity Readiness Questionnaire - Not currently meeting physical activity guidelines per leisure-time physical activity participation questionnaire - Access to and ability to use a computer, tablet or phone device with internet access - Ability to understand and read English - Written informed consent obtained from subject and ability for subject to comply with the requirements of the study Exclusion Criteria: - Hearing loss or vision impairment that would preclude the participant from accessing and using the app (use of hearing aids or visual aids is acceptable) based on self-report - Currently meeting physical activity guidelines (score of >23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire) - Currently pregnant, based on self-report - Patients with active treatment planned within the next 3 months. (Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination.) Long-term hormonal/biologic treatments are acceptable except for AR-targeted therapies for prostate cancer. Participants with known metastatic disease, grade 3 or higher neuropathy, major surgery within 3 months of baseline visit, pregnancy of childbearing potential will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center | Walter Reed National Military Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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