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

NCT ID: NCT06260332

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Supportive Care (Fitbit)

Intervention Type: BEHAVIORAL

Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies

Interventions

Supportive Care (Fitbit)

Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies

Intervention Type: BEHAVIORAL

Other Intervention Names

Medical Device Usage and Evaluation; Internet-Based Intervention; Educational Activity; Counseling; Survey Administration

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: collaborator

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacklyn M Nemunaitis, MD

Role: PRINCIPAL_INVESTIGATOR

New Mexico Cancer Research Alliance

Cindy K Blair, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New Mexico Cancer Research Alliance

Locations

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Countries

United States

Related Links

https://seer.cancer.gov/statfacts/html/breast.html

NIH. (n.d.). Cancer of the breast (female) - cancer stat facts. SEER. Retrieved January 22, 2023

http://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis

PROMIS: Patient-Reported Outcomes Measurement Information System

Other Identifiers

23-293

Identifier Type: OTHER

Identifier Source: secondary_id

INST UNM 2302

Identifier Type: -

Identifier Source: org_study_id