Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors

October 21, 2025 updated by: New Mexico Cancer Research Alliance

Move Toward Recovery: A Physical Activity Intervention to Reduce Persistent Pain Following Breast Surgery for Cancer in Young, Hispanic Women

This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the feasibility of a physical activity intervention in young, Hispanic women with chronic post-operative pain after breast surgery for invasive breast cancer, termed post breast surgery pain syndrome (PBSPS) for this study.

SECONDARY OBJECTIVES:

I. To assess the preliminary efficacy of a physical activity intervention in decreasing pain in young, Hispanic women with PBSPS.

II. To assess the preliminary efficacy of the physical activity intervention in increasing physical activity and improving health-related quality of life (hrQOL).

OUTLINE:

Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women who have completed surgery for invasive breast cancer >= 6 months prior to enrollment
  • Any breast surgery (lumpectomy or mastectomy)
  • Baseline low to moderate activity level (exercise less than 120 minutes a week)
  • PBSPS defined as pain in the area of breast surgery of at least moderate intensity (>= 4 on a scale of 1-10), located in the ipsilateral beast/chest wall, axilla or arm, lasting at least 6 months, and occurring at least 50% of the time
  • Self-identified as Hispanic/Latinx
  • Age, >= 18 and =< 60 years
  • Endocrine therapy and ovarian suppression is allowed

Exclusion Criteria:

  • Metastatic or locally recurrent disease with no option for curative intent treatment
  • Meeting or exceeding physical activity guidelines (> 150 minutes per week of moderate-intensity exercise)
  • Unable to speak, read, and understand English or Spanish
  • Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily physical activity. This is defined as the ability to walk 3 blocks without stopping to rest and without using an assistive device
  • Unwilling to use a study provided smartphone (if do not already own one) and wear activity trackers/monitors
  • Adults not able to consent are excluded from participation
  • Based on the age criteria (18 years and older), individuals who are not yet adults (infants, children, teenagers) may not participate in this study due to the same age criteria above
  • Pregnant women
  • Prisoners may not participate in this study as this is a study of free-living individuals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive Care (Fitbit)
Patients wear a Fitbit and use the Fitbit application to monitor their physical activity daily in weeks 2-12 with the goal of increasing their number of steps per day and their number of active hours per day. Starting at week 2, patients also receive educational materials and attend 6 calls over 20-60 minutes each with their health coach in weeks 2, 3, 5, 7, 9, and 11.
Behavioral: Supportive Care (Fitbit)
Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies
Other Names:
  • Counseling
  • Survey Administration
  • Medical Device Usage and Evaluation
  • Internet-Based Intervention
  • Educational Activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate (Feasibility)
Time Frame: Up to 1 year
This study will be considered feasible with the recruitment of 25 breast cancer patients.
Up to 1 year
Retention rate (Feasibility)
Time Frame: Up to 12 weeks
This study will be considered feasible if 80% of patients complete all pre and post assessments.
Up to 12 weeks
Adherence rate (Feasibility)
Time Frame: Up to 12 weeks
This study will be considered feasible if participants complete at least 4 of 5 health coaching sessions (80%).
Up to 12 weeks
Incidence of adverse events
Time Frame: Up to 12 weeks
Safety will be tracked by the study team.
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in chronic post-surgical pain
Time Frame: At 13 weeks
Reducing chronic post-surgical pain will be measured using the Defense and Veterans Pain Rating Scale. Will also be assessed by Bodily Threat Monitoring Scale and pain self-efficacy questionnaire. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests.
At 13 weeks
Change in physical activity
Time Frame: At 13 weeks
Increasing physical activity will be measured using accelerometry data using the activePAL activity monitor. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests.
At 13 weeks
Change in health-related quality of life (hrQOL)
Time Frame: At 13 weeks
Improvement in hrQOL will be measured using Patient-Reported Outcomes Measurement Information System surveys. Will summarize change scores with means and standard deviations, or medians and interquartile ranges, and obtain 95% confidence intervals. Will perform one-sided paired t-tests, or Wilcoxon signed rank tests.
At 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Mexico Cancer Research Alliance

Collaborators

University of New Mexico

Investigators

  • Principal Investigator: Jacklyn M Nemunaitis, MD, New Mexico Cancer Research Alliance
  • Principal Investigator: Cindy K Blair, Ph.D., New Mexico Cancer Research Alliance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Actual)

August 27, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INST UNM 2302
  • 23-293 (UNM HSC IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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