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NCT Number: NCT05131815

The BurnAlong Pilot Study 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.

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Key information

Conditions

Cancer Astrocytoma Behavior Blood Protein Disorders Bone Cancer Bone Diseases Bone Neoplasms Brain Cancer Brain Diseases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Cancer Metastatic Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glioblastoma Glioma Gynecologic Cancer Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Leukemia Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Motor Activity Multiple Myeloma Musculoskeletal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Walter Reed National Military Medical Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2021
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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