Clinical trial NCT06260332: Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors
Official title: Move Toward Recovery: A Physical Activity Intervention to Reduce Persistent Pain Following Breast Surgery for Cancer in Young, Hispanic Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: University of New Mexico
First posted: 2024-02-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Recruitment rate (Feasibility)
timeFrame: Up to 1 year
measure: Retention rate (Feasibility)
timeFrame: Up to 12 weeks
measure: Adherence rate (Feasibility)
timeFrame: Up to 12 weeks
measure: Incidence of adverse events
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change in chronic post-surgical pain
timeFrame: At 13 weeks
measure: Change in physical activity
timeFrame: At 13 weeks
measure: Change in health-related quality of life (hrQOL)
timeFrame: At 13 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
Study officials:
affiliation: New Mexico Cancer Research Alliance
name: Jacklyn M Nemunaitis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New Mexico Cancer Research Alliance
name: Cindy K Blair, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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