Aerobic Exercise, Resistance Exercise, or Flexibility and Relaxation Training in Inactive Older Female Breast Cancer Survivors - Full Text View

Sponsor:	OHSU Knight Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00662103

Purpose

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.

Condition	Intervention
Breast Cancer Cancer Survivor Fatigue Long-term Effects Secondary to Cancer Therapy in Adults Psychosocial Effects of Cancer and Its Treatment	Behavioral: exercise intervention Other: laboratory biomarker analysis Other: questionnaire administration Other: survey administration Procedure: assessment of therapy complications Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: psychosocial assessment and care

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness Fatigue

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:

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 [ Time Frame: baseline,3 ,6 ,12, and 18 months ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline, 3 , 6 ,12, and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: baseline, 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline, 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]
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 ... [ Time Frame: baseline, 3, 6, 12, and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	141
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2011
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Behavioral: exercise intervention 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. Other: laboratory biomarker analysis All biomarkers will be measured from urine, blood and plasma obtained from participants by the 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. Other: questionnaire administration 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. Other: survey administration Administered at measured at baseline, 3, 6, 12, and 18 months Procedure: assessment of therapy complications Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months ) Procedure: fatigue assessment and management 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 Procedure: management of therapy complications 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. Procedure: psychosocial assessment and care 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
Active Comparator: progressive, resistance exercise program Patients undergo resistance exercise training 3 days a week for 18 months.	Behavioral: exercise intervention 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. Other: laboratory biomarker analysis All biomarkers will be measured from urine, blood and plasma obtained from participants by the 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. Other: questionnaire administration 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. Other: survey administration Administered at measured at baseline, 3, 6, 12, and 18 months Procedure: assessment of therapy complications Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months ) Procedure: fatigue assessment and management 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 Procedure: management of therapy complications 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. Procedure: psychosocial assessment and care 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
Active Comparator: flexibility and relaxation training [control] 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.	Other: laboratory biomarker analysis All biomarkers will be measured from urine, blood and plasma obtained from participants by the 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. Other: questionnaire administration 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. Other: survey administration Administered at measured at baseline, 3, 6, 12, and 18 months Procedure: assessment of therapy complications Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months ) Procedure: fatigue assessment and management 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 Procedure: management of therapy complications 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. Procedure: psychosocial assessment and care 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

Show Detailed Description

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
- Stage 0-III disease
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:

Menopausal status not specified
Has obtained medical clearance to participate in study exercise programs
No cognitive difficulties that would preclude answering the survey questions, participating in the performance tests, or giving informed consent
No medical condition or movement or neurological disorder that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent medication that would contraindicate participation in moderate intensity exercise training, as determined by physician clearance and the Principal Investigator
Concurrent hormonal therapy (e.g., selective estrogen receptor modulator [SERM] or aromatase inhibitor) for breast cancer allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662103

Locations

United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kerri Winters-Stone, PhD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00662103 History of Changes
Obsolete Identifiers:	NCT00665080
Other Study ID Numbers:	CDR0000593410, R01CA120123, P30CA069533, OHSU-CR00005268, OHSU-IRB00003316
Study First Received:	April 18, 2008
Last Updated:	September 22, 2011
Health Authority:	United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:

fatigue
long-term effects secondary to cancer therapy in adults
psychosocial effects of cancer and its treatment
cancer survivor
stage IA breast cancer
stage IB breast cancer

stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
breast cancer in situ

Additional relevant MeSH terms:

Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012