NCT04064892

Brief Summary

The proposed mixed methods pilot study will enroll 20 young breast cancer survivors into a 12-week technology-based, remotely-delivered, peer-moderated physical activity program to examine the effects of the intervention on objectively measured physical activity and multiple aspects of quality of life; and conduct qualitative analyses to refine the intervention for a future randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable breast-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

August 19, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

August 19, 2019

Last Update Submit

November 2, 2020

Conditions

Breast CancerQuality of LifePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    The ActiGraph GT3X+ accelerometer will be used to measure change in minutes of moderate to vigorous physical activity from baseline to 12 weeks. For 7 days around each assessment time point, participants will wear the accelerometer.

    Baseline to 12 weeks

Secondary Outcomes (3)

  • Body Image Scale

    Baseline to 12 weeks

  • Female Sexual Function Index

    Baseline to 12 weeks

  • PROMIS Cancer - Fatigue

    Baseline to 12 weeks

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Participants will receive a 12-week, individually-tailored, video conference-based physical activity intervention

Behavioral: Exercise Intervention

Interventions

Exercise InterventionBEHAVIORAL

The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, \& Fitbit message board) to support behavior change. All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly. Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.

Exercise Intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with breast cancer between 18-49 years old
  • Completed active treatment (chemotherapy, radiation) at least 6 months prior to enrollment
  • Self-report low levels of moderate to vigorous physical activity each week
  • Accessible by phone or video chat
  • Have a Fitbit compatible cellphone, tablet, or laptop with Internet

You may not qualify if:

  • medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
  • currently pregnant
  • unable to commit to intervention schedule
  • prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (2)

  • Weiner LS, Nagel S, Irene Su H, Hurst S, Levy SS, Arredondo EM, Hekler E, Hartman SJ. A remotely delivered, peer-led intervention to improve physical activity and quality of life in younger breast cancer survivors. J Behav Med. 2023 Aug;46(4):578-593. doi: 10.1007/s10865-022-00381-8. Epub 2022 Dec 7.

    PMID: 36479658DERIVED

  • Weiner LS, Nagel S, Su HI, Hurst S, Hartman SJ. A Remotely Delivered, Peer-Led Physical Activity Intervention for Younger Breast Cancer Survivors (Pink Body Spirit): Protocol for a Feasibility Study and Mixed Methods Process Evaluation. JMIR Res Protoc. 2020 Jul 8;9(7):e18420. doi: 10.2196/18420.

    PMID: 32673270DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

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

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 22, 2019

Study Start

September 1, 2019

Primary Completion

August 31, 2020

Study Completion

September 30, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)