The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131815
• Other study ID #: IIT2020-24-SHIRAZIP-BURN
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: August 21, 2023

Study information

• Verified date: August 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 21, 2023
• 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.

Related Conditions & MeSH terms

• Bone Cancer
• Bone Neoplasms
• Brain Cancer
• Brain Neoplasms
• Breast Cancer
• Cancer
• Cancer Metastatic
• Colorectal Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Glioblastoma
• Gynecologic Cancer
• Head and Neck Cancer
• Hodgkin Lymphoma
• Leukemia
• Lung Cancer
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Sarcoma
• Skin Cancer
• Thyroid Cancer

Intervention

Behavioral:
• Virtual group based physical activity (BurnAlong) and Social Media Discussion Board
Participants will engage in two to three virtual physical activity sessions a week through the BurnAlong app for three months with a chosen partner and participate at least twice a week in the research team-mediated social media message board. Additionally, participants will be asked to participate in one live physical activity session per month with an exercise physiologist.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   virtual physical activity platform