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

New Mexico Cancer Research Alliance

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Behavioral: Supportive Care (Fitbit)

Study type

Interventional

Funder types

Other

Identifiers

NCT06260332

23-293 (Other Identifier)

INST UNM 2302

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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