Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05131815
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : February 23, 2022
Sponsor:
Collaborator:
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
Celina Shirazipour, Cedars-Sinai Medical Center

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Virtual group based physical activity (BurnAlong) and Social Media Discussion Board Not Applicable

Detailed Description:

This is a single-arm, prospective, interventional pilot study.

Adolescent and young adult (AYA) survivors of cancer (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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention for Adolescent and Young Adult Cancer Survivors
Actual Study Start Date : January 10, 2022
Estimated Primary Completion Date : January 10, 2023
Estimated Study Completion Date : January 9, 2024


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cancer (all types) diagnosis between the ages of 15-25
  • Between the ages of 18-25 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05131815


Contacts
Layout table for location contacts
Contact: Jessica Capaldi, MA 310-423-9492 jessica.capaldi@cshs.org
Contact: Celina H Shiraizipour, Ph.D. 310-423-1245 celina.shirazipour@cshs.org

Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Celina H Shirazipour, Ph.D.       celina.shirazipour@cshs.org   
Contact: Jessica M Capaldi, MA       jessica.capaldi@cshs.org   
Principal Investigator: Celina H Shirazipour, Ph.D.         
Sub-Investigator: Gillian Gresham, Ph.D.         
Sub-Investigator: Sarah Salvy, Ph.D.         
Sub-Investigator: Laurel Finster, MPH         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Walter Reed National Military Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Susan Whiteway, LtCol USAF, MD Walter Reed National Military Medical Center
Principal Investigator: Celina H Shirazipour, Ph.D. Cedars-Sinai Medical Center
Additional Information:
Layout table for additonal information
Responsible Party: Celina Shirazipour, Assistant Professor, Cancer Research Center for Health Equity, SOCCI, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05131815    
Other Study ID Numbers: IIT2020-24-SHIRAZIP-BURN
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celina Shirazipour, Cedars-Sinai Medical Center:
virtual exercise
adolescent and young adult cancer
BurnAlong App
Well-being
cancer
physical activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Multiple Myeloma
Glioblastoma
Gastrointestinal Neoplasms
Pancreatic Neoplasms
Lymphoma, Non-Hodgkin
Brain Neoplasms
Bone Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors