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

Summary

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.

Conditions

• Breast Cancer
• Cancer Survivor
• Fatigue
• Long-term Effects Secondary to Cancer Therapy in Adults
• Psychosocial Effects of Cancer and Its Treatment

Interventions

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 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.

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Kerri Winters-Stone, PhD · OHSU Knight Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

120 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2010-06-30

Completion

2010-06-30

Countries

• United States

Study Locations