| ID | Type | Description | Link |
|---|---|---|---|
| R01CA120123 | U.S. NIH Grant/Contract | View source | |
| P30CA069533 | U.S. NIH Grant/Contract | View source | |
| OHSU-CR00005268 | |||
| OHSU-IRB00003316 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may reduce fatigue and improve the health and quality of life of breast cancer survivors. It is not yet known which type of exercise is more effective for inactive older female breast cancer survivors.
PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works compared with resistance exercise or flexibility and relaxation training in improving the health and quality of life of inactive older female breast cancer survivors.
OBJECTIVES:
Primary:
Secondary:
OUTLINE: Patients are stratified according to current use of hormone manipulation therapy (none vs tamoxifen vs arimidex). Patients are randomized to 1 of 3 intervention arms.
Muscle strength (measured by a one-repetition maximum test), aerobic capacity (measured by a 6-minute walk test), functional arm strength (measured by grip dynamometer), physical functioning (measured by the Physical Performance Battery), flexibility (measured by the Chair Sit and Reach Test and the Back Scratch Test), balance (measured by a one-legged stance [Romberg] test and a timed stance test), lymphedema (measured by the circumference of the upper arm, wrist, and a finger), body composition (measured by dual energy x-ray absorptiometry), and bone mineral density of the heel (measured by ultrasound) are assessed at baseline and periodically during the study. Patients also undergo blood and urine sample collection for cancer recurrence biomarker and bone remodeling biomarker studies.
Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| progressive, aerobic exercise program | Active Comparator | Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months. |
|
| progressive, resistance exercise program | Active Comparator | Patients undergo resistance exercise training 3 days a week for 18 months. |
|
| flexibility and relaxation training [control] | Active Comparator | Patients perform a series of whole body flexibility (stretching) and relaxation (guided imagery, progressive neuromuscular relaxation, focused breathing) exercises 3 days a week for 18 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise intervention | Behavioral | Arm I (progressive, aerobic exercise program): Patients undergo aerobic exercise training over approximately 45 minutes (not including warm-up or cool-down exercises) 3 days a week for 18 months. Arm II (progressive, resistance exercise program): Patients undergo resistance exercise training 3 days a week for 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months | baseline,3 ,6 ,12, and 18 months | |
| Comparison of the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months | baseline, 3 , 6 ,12, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health as measured at baseline and at 3, 6, 12, and 18 months | baseline, 3, 6, 12, and 18 months | |
| Determination of the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning as measured at baseline and at 3, 6, 12, and 18 months |
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DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Completed chemotherapy or radiotherapy > 2 years ago
Is not a regular participant in moderate aerobic exercise (i.e., jogging, swimming) or moderate resistance exercise (> 3 times/week for ≥ 30 minutes/session) OR in vigorous aerobic or resistance exercise (> 3 times/week for ≥ 20 minutes/session)
No stage IV breast cancer
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kerri Winters-Stone, PhD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34426142 | Derived | Winters-Stone KM, Torgrimson-Ojerio B, Dieckmann NF, Stoyles S, Mitri Z, Luoh SW. A randomized-controlled trial comparing supervised aerobic training to resistance training followed by unsupervised exercise on physical functioning in older breast cancer survivors. J Geriatr Oncol. 2022 Mar;13(2):152-160. doi: 10.1016/j.jgo.2021.08.003. Epub 2021 Aug 21. | |
| 29141853 | Derived | Winters-Stone KM, Wood LJ, Stoyles S, Dieckmann NF. The Effects of Resistance Exercise on Biomarkers of Breast Cancer Prognosis: A Pooled Analysis of Three Randomized Trials. Cancer Epidemiol Biomarkers Prev. 2018 Feb;27(2):146-153. doi: 10.1158/1055-9965.EPI-17-0766. Epub 2017 Nov 15. |
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| laboratory biomarker analysis | Other | All biomarkers will be measured from urine, blood and plasma obtained from participants by the Oregon Health & Science University (OHSU) General Clinical Research Center (GCRC). Upon exit from the study we will confirm the presence/absence of metastatic disease, via verbal verification by the subject, in order to ensure that biomarkers were primarily reflective of bone turnover changes and not to metastases. |
|
| questionnaire administration | Other | Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function. |
|
| survey administration | Other | Administered at measured at baseline, 3, 6, 12, and 18 months |
|
| assessment of therapy complications | Procedure | Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months ) |
|
| fatigue assessment and management | Procedure | The Schwartz Cancer Fatigue (SCF) scale, a 6-item scale that specifically assesses the level of subjective fatigue that the participant is currently experiencing. The SCF has been used to measure fatigue in previous exercise studies. The Piper Fatigue Scale (PFS) consists of 22 items and four subscales: behavioral/severity, affective meaning, sensory and cognitive/mood. The scale has been shown to detect reductions in fatigue in cancer patients undergoing behavioral interventions to reduce fatigue, including exercise. Responses are averaged for subscale and total scores with higher scores indicating more fatigue. The PFS has been used to measure fatigue in previous studies of illness and/or medical treatments. 15 minute survey |
|
| management of therapy complications | Procedure | An interim safety/efficacy review will occur after the first half of enrolled participants completes their 3 month testing appointment (or after 3 months of exercise). The interim safety review will be overseen by OHSU NCI-designated Cancer Institute, while the efficacy review will be conducted by an independent monitor, Dr. George Knafl, a biostatistician in the OHSU School of Nursing, who is not a member of the study personnel. |
|
| psychosocial assessment and care | Procedure | We will include a 6-item measure of self-efficacy for exercise that has been validated in adults (Nigg, 2002) and has been used by Dr. Bennett (Co-I) in current work in cancer survivors. 5 min. survey |
|
| baseline, 3, 6, 12, and 18 months |
| Comparison of the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence as measured at baseline and at 3, 6, 12, and 18 ... | baseline, 3, 6, 12, and 18 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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