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Clinical Trial NCT06260332 for Breast Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors

Active, not recruiting
Clinical Trial NCT06260332 is an interventional study for Breast Cancer that is active, not recruiting. It started on October 20, 2023 with plans to enroll 25 participants. Led by New Mexico Cancer Research Alliance, it is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on October 23, 2025.
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.

Official Title

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

Conditions
Breast Cancer
Other Study IDs
  • INST UNM 2302
  • 23-293 (Other Identifier) (UNM HSC IRB)
NCT ID Number
NCT06260332
Start Date (Actual)
2023-10-20
Last Update Posted
2025-10-23
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Supportive Care
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSupportive 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.
Supportive Care (Fitbit)
Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in chronic post-surgical pain
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
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)
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
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • 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
New Mexico Cancer Research Alliance logoNew Mexico Cancer Research Alliance
University of New Mexico logoUniversity of New Mexico69 active trials to explore
No contact data.
1 Study Locations in 1 Countries

New Mexico

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