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Breast CancerNCT06260332

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

A study testing Supportive Care (Fitbit) in people with Breast Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Supportive Care (Fitbit)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
20 Oct 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of New Mexico Comprehensive Cancer Center

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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
Being tested
Supportive Care (Fitbit)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive Care (Fitbit)Behavioural

    Also called Medical Device Usage and Evaluation, Internet-Based Intervention, Educational Activity, Counseling

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

Study groups in NCT06260332
Study groupRoleWhat they receive
Supportive Care (Fitbit)ExperimentalPatients 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.
Receives: Behavioral: Supportive Care (Fitbit)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate (Feasibility)

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

    Measured: Up to 1 year

  2. Retention rate (Feasibility)

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

    Measured: Up to 12 weeks

  3. Adherence rate (Feasibility)

    This study will be considered feasible if participants complete at least 4 of 5 health coaching sessions (80%).

    Measured: Up to 12 weeks

  4. Incidence of adverse events

    Safety will be tracked by the study team.

    Measured: Up to 12 weeks

Secondary outcomes (3)

  1. 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.

    Measured: At 13 weeks

  2. 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.

    Measured: At 13 weeks

  3. 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.

    Measured: At 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start20 Oct 2023
  3. Primary completion27 Aug 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06260332
Sponsor's protocol ID
INST UNM 2302
Other IDs
23-293
Status last verified
Oct 2025
First submitted
23 Jan 2024
Last updated
23 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rosenberg S, Boyce T, Walters ST, Barriga L, Torres J, Pankratz VS, Tawfik B, Prabhakaran S, Fine S, Buro AW, Brown Glaberman U, Blair C, Nemunaitis J. Move Toward Recovery: A Feasibility Study for a Physical Activity Intervention to Reduce Post-Surgical Pain in Young Hispanic Breast Cancer Patients. Int J Environ Res Public Health. 2026 Jul 31;23(8):1003. doi: 10.3390/ijerph23081003.

    PubMed 42652318

Questions about this trial

What is this clinical trial studying?

A study testing Supportive Care (Fitbit) in people with Breast Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (Feasibility) (time frame: Up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06260332, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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