CancerNCT05131815
The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors
A study testing Virtual group based physical activity (BurnAlong) and Social Media Discussion Board in people with Cancer and Cancer Metastatic, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cancer Metastatic, Neoplasms
- What is being tested?
- Virtual group based physical activity (BurnAlong) and Social Media Discussion Board
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention 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.
Read the 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.
- Conditions
- Cancer, Cancer Metastatic, Neoplasms, Breast Cancer, Lung Cancer, Thyroid Cancer
- Being tested
- Virtual group based physical activity (BurnAlong) and Social Media Discussion Board
- Keywords
- virtual exercise, adolescent and young adult cancer, BurnAlong App, Well-being, cancer, physical activity
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Breast Neoplasms, Lung Neoplasms, Thyroid Neoplasms, Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual group based physical activity (BurnAlong) and Social Media Discussion BoardBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Group-Based Physical Activity (BurnAlong) and Discussion Board | Experimental | 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. Receives: Behavioral: Virtual group based physical activity (BurnAlong) and Social Media Discussion Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (9)
Resting Heart Rate
Evaluate impact of intervention on resting heart rate (bpm) at 3-months (compared to baseline day 0)
Measured: Measured at Baseline and at Week 12
Sleep Duration
Evaluate impact of intervention on sleep duration (number of hours slept each night) at 3-months (compared to baseline day 0)
Measured: Measured at Baseline and at Week 12
Sleep Quality
Evaluate impact of intervention on the percentage of time awake during the night at 3-months (compared to baseline day 0)
Measured: Measured at Baseline and at Week 12
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.
Measured: Measured at Baseline and at Week 12
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
Measured: Measured at Baseline and at Week 12
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
Measured: Measured at Baseline and at Week 12
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.
Measured: Measured at Baseline and at Week 12
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
Measured: Measured at Baseline and at Week 12
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)
Measured: Measured at Baseline and at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start25 Jul 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center
- Responsible party
- Principal investigator, Celina Shirazipour, Cedars-Sinai Medical Center
- Investigators
- Susan Whiteway, LtCol USAF, MD, Principal investigator, Walter Reed National Military Medical CenterCelina H Shirazipour, Ph.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131815
- Sponsor's protocol ID
- IIT2020-24-SHIRAZIP-BURN
- Status last verified
- Feb 2025
- First submitted
- 2 Nov 2021
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention for Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT05131815
- Acronym / sponsor ID
- IIT2020-24-SHIRAZIP-BURN
- Conditions
- Cancer, Cancer Metastatic, Neoplasms, Breast Cancer, Lung Cancer, Thyroid Cancer
- Keywords
- virtual exercise, adolescent and young adult cancer, BurnAlong App, Well-being, cancer, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Group-Based Physical Activity (BurnAlong) and Discussion Board | Experimental | Behavioral: Virtual group based physical activity (BurnAlong) and Social Media Discussion BoardParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual group based physical activity (BurnAlong) and Social Media Discussion BoardParticipants 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. | Behavioural | Virtual Group-Based Physical Activity (BurnAlong) and Discussion Board |
Primary outcome
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
9 secondary outcomes
Resting Heart Rate
Time frame: Measured at Baseline and at Week 12
Sleep Duration
Time frame: Measured at Baseline and at Week 12
Sleep Quality
Time frame: Measured at Baseline and at Week 12
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: Measured at Baseline and at Week 12
Post-Traumatic Growth Inventory (PTGI)
Time frame: Measured at Baseline and at Week 12
Health Action Process Approach Inventory (HAPA Inventory)
Time frame: Measured at Baseline and at Week 12
Patient-Reported Outcomes Measurement Information System (PROMIS) Social Support
Time frame: Measured at Baseline and at Week 12
Adolescent and Young Adult Psycho-Oncology Screening Tool (AYA-POST)
Time frame: Measured at Baseline and at Week 12
Measure of Experiential Aspects of Participation (MeEAP)
Time frame: Measured at Baseline and at Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- virtual physical activity platformLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Whiteway, LtCol USAF, MD principal investigator
Walter Reed National Military Medical Center
Celina H Shirazipour, Ph.D. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual group based physical activity (BurnAlong) and Social Media Discussion Board in people with Cancer and Cancer Metastatic, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of BurnAlong (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.