The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors

August 24, 2023 updated by: Celina Shirazipour, Cedars-Sinai Medical Center

The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of BurnAlong
Time Frame: 12 weeks
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

Outcome Measure
Measure Description
Time Frame
Resting Heart Rate
Time Frame: Measured at Baseline and at Week 12
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
Time Frame: Measured at Baseline and at Week 12
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
Time Frame: Measured at Baseline and at Week 12
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
Time Frame: Measured at Baseline and at Week 12
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)
Time Frame: Measured at Baseline and at Week 12
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)
Time Frame: Measured at Baseline and at Week 12
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
Time Frame: Measured at Baseline and at Week 12
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)
Time Frame: Measured at Baseline and at Week 12
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)
Time Frame: Measured at Baseline and at Week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

Walter Reed National Military Medical Center

Investigators

  • Principal Investigator: Susan Whiteway, LtCol USAF, MD, Walter Reed National Military Medical Center
  • Principal Investigator: Celina H Shirazipour, Ph.D., Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

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 Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

July 6, 2023

Study Completion (Actual)

August 21, 2023

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 23, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2020-24-SHIRAZIP-BURN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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