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

NCT06260332 | Active Not Recruiting

• 2 other identifiers: INST UNM 230223-293
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Recruitment rate (Feasibility)

  This study will be considered feasible with the recruitment of 25 breast cancer patients.

  Up to 1 year

• Retention rate (Feasibility)

  This study will be considered feasible if 80% of patients complete all pre and post assessments.

  Up to 12 weeks

• Adherence rate (Feasibility)

  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

  Safety will be tracked by the study team.

  Up to 12 weeks

Secondary Outcomes (3)

• Change in chronic post-surgical pain

  At 13 weeks

• Change in physical activity

  At 13 weeks

• Change in health-related quality of life (hrQOL)

  At 13 weeks

Study Arms (1)

Supportive Care (Fitbit)

EXPERIMENTAL

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)

Interventions

Supportive Care (Fitbit) BEHAVIORAL

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

Also known as: Medical Device Usage and Evaluation, Internet-Based Intervention, Educational Activity, Counseling, Survey Administration

Supportive Care (Fitbit)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• University of New Mexico: collaborator

Study Sites (1)

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Related Links

• NIH. (n.d.). Cancer of the breast (female) - cancer stat facts. SEER. Retrieved January 22, 2023
• PROMIS: Patient-Reported Outcomes Measurement Information System

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Palliative Care; Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services

Study Officials

• Jacklyn M Nemunaitis, MD

  New Mexico Cancer Research Alliance

  PRINCIPAL INVESTIGATOR

• Cindy K Blair, Ph.D.

  New Mexico Cancer Research Alliance

  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: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 15, 2024
• Study Start: October 20, 2023
• Primary Completion: August 27, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)