NCT05131815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

November 2, 2021

Last Update Submit

February 24, 2025

Conditions

CancerCancer MetastaticNeoplasmsBreast CancerLung CancerThyroid CancerLymphomaLymphoma, Non-HodgkinHodgkin LymphomaLeukemiaSarcomaSkin CancerBone CancerGynecologic CancerPancreas CancerMultiple MyelomaColorectal CancerGastrointestinal CancerProstate CancerGlioblastomaBrain CancerHead and Neck Cancer

Keywords

virtual exerciseadolescent and young adult cancerBurnAlong AppWell-beingcancerphysical activity

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (9)

  • Resting Heart Rate

    Measured at Baseline and at Week 12

  • Sleep Duration

    Measured at Baseline and at Week 12

  • Sleep Quality

    Measured at Baseline and at Week 12

  • Patient-Reported Outcomes Measurement Information System (PROMIS)-29

    Measured at Baseline and at Week 12

  • Post-Traumatic Growth Inventory (PTGI)

    Measured at Baseline and at Week 12

  • +4 more secondary outcomes

Study Arms (1)

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.

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

Interventions

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

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.

Virtual Group-Based Physical Activity (BurnAlong) and Discussion Board

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisBreast NeoplasmsLung NeoplasmsThyroid NeoplasmsLymphomaLymphoma, Non-HodgkinHodgkin DiseaseLeukemiaSarcomaSkin NeoplasmsBone NeoplasmsPancreatic NeoplasmsMultiple MyelomaColorectal NeoplasmsGastrointestinal NeoplasmsProstatic NeoplasmsGlioblastomaBrain NeoplasmsHead and Neck NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesNeoplasms, Connective and Soft TissueBone DiseasesMusculoskeletal DiseasesDigestive System NeoplasmsDigestive System DiseasesPancreatic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersIntestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Susan Whiteway, LtCol USAF, MD

    Walter Reed National Military Medical Center

    PRINCIPAL INVESTIGATOR

  • Celina H Shirazipour, Ph.D.

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Cancer Research Center for Health Equity, SOCCI

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 23, 2021

Study Start

July 25, 2022

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)