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| ID | Type | Description | Link |
|---|---|---|---|
| 23-293 | Other Identifier | UNM HSC IRB |
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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (Fitbit) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Care (Fitbit) | Behavioral | Wear Fitbit, Use Fitbit application, Receive educational materials, attend coaching calls, Ancillary studies |
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| Measure | Description | Time 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 |
| Measure | Description | Time 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. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Jacklyn M Nemunaitis, MD | New Mexico Cancer Research Alliance | Principal Investigator |
| Cindy K Blair, Ph.D. | New Mexico Cancer Research Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87106 | United States |
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| Label | URL |
|---|---|
| NIH. (n.d.). Cancer of the breast (female) - cancer stat facts. SEER. Retrieved January 22, 2023 | View source |
| PROMIS: Patient-Reported Outcomes Measurement Information System | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |