Clinical trial NCT05131815: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
First posted: 2021-11-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of BurnAlong
timeFrame: 12 weeks
Secondary outcomes:
measure: Resting Heart Rate
timeFrame: Measured at Baseline and at Week 12
measure: Sleep Duration
timeFrame: Measured at Baseline and at Week 12
measure: Sleep Quality
timeFrame: Measured at Baseline and at Week 12
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-29
timeFrame: Measured at Baseline and at Week 12
measure: Post-Traumatic Growth Inventory (PTGI)
timeFrame: Measured at Baseline and at Week 12
measure: Health Action Process Approach Inventory (HAPA Inventory)
timeFrame: Measured at Baseline and at Week 12
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Social Support
timeFrame: Measured at Baseline and at Week 12
measure: Adolescent and Young Adult Psycho-Oncology Screening Tool (AYA-POST)
timeFrame: Measured at Baseline and at Week 12
measure: Measure of Experiential Aspects of Participation (MeEAP)
timeFrame: Measured at Baseline and at Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Susan Whiteway, LtCol USAF, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Celina H Shirazipour, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: