The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual group based physical activity (BurnAlong) and Social Media Discussion Board

About this trial

This is an interventional supportive care trial for Cancer focused on measuring virtual exercise, adolescent and young adult cancer, BurnAlong App, Well-being, cancer, physical activity

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Cancer (all types) diagnosis between the ages of 15-29
Between the ages of 18-29 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.

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Group-Based Physical Activity (BurnAlong) and Discussion Board

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Resting Heart Rate

Evaluate impact of intervention on resting heart rate (bpm) at 3-months (compared to baseline day 0)

Sleep Duration

Evaluate impact of intervention on sleep duration (number of hours slept each night) at 3-months (compared to baseline day 0)

Sleep Quality

Evaluate impact of intervention on the percentage of time awake during the night at 3-months (compared to baseline day 0)

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.

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

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

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.

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

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)

Full Information

NCT ID

NCT05131815

First Posted

November 2, 2021

Last Updated

August 24, 2023

Sponsor

Cedars-Sinai Medical Center

Collaborators

Walter Reed National Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05131815

Brief Title

The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors

Official Title

The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention for Adolescent and Young Adult Cancer Survivors

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 10, 2022 (Actual)

Primary Completion Date

July 6, 2023 (Actual)

Study Completion Date

August 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

Collaborators

Walter Reed National Military Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

virtual exercise, adolescent and young adult cancer, BurnAlong App, Well-being, cancer, physical activity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual Group-Based Physical Activity (BurnAlong) and Discussion Board

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Virtual group based physical activity (BurnAlong) and Social Media Discussion Board

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of BurnAlong

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Resting Heart Rate

Description

Evaluate impact of intervention on resting heart rate (bpm) at 3-months (compared to baseline day 0)

Time Frame