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Trial Title:
Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors
NCT ID:
NCT06260332
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Supportive Care (Fitbit)
Description:
Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching
calls, Ancillary studies
Arm group label:
Supportive Care (Fitbit)
Other name:
Medical Device Usage and Evaluation
Other name:
Internet-Based Intervention
Other name:
Educational Activity
Other name:
Counseling
Other name:
Survey Administration
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Female
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of New Mexico Comprehensive Cancer Center
Address:
City:
Albuquerque
Zip:
87106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ellen R Wojcik, MBA-HCM
Email:
ewojcik@salud.unm.edu
Contact backup:
Last name:
Cheryl A Sampson, MBA
Email:
ChSampson@salud.unm.edu
Investigator:
Last name:
Jacklyn M Nemunaitis, MD
Email:
Principal Investigator
Investigator:
Last name:
Cindy K Blair, Ph.D.
Email:
Sub-Investigator
Start date:
October 20, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
New Mexico Cancer Care Alliance
Agency class:
Other
Collaborator:
Agency:
University of New Mexico
Agency class:
Other
Source:
New Mexico Cancer Care Alliance
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06260332
https://seer.cancer.gov/statfacts/html/breast.html
http://www.healthmeasures.net/explore-measurement-systems/promis/intro-to-promis
