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The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 39 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05131815
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Cedars-Sinai Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Susan Whiteway, LtCol USAF, MDCelina H Shirazipour, Ph.D.
Principal Investigator Affiliation Walter Reed National Military Medical CenterCedars-Sinai Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, U.S. Fed
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

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