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

NCT00662103 | Completed

• 5 other identifiers: CDR0000593410R01CA120123P30CA069533OHSU-CR00005268OHSU-IRB00003316
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

  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

Study Arms (3)

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.

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

progressive, resistance exercise program

ACTIVE COMPARATOR

Patients undergo resistance exercise training 3 days a week for 18 months.

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

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.

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

Interventions

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.

progressive, aerobic exercise program; progressive, resistance exercise program

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.

flexibility and relaxation training [control]; progressive, aerobic exercise program; progressive, resistance exercise program

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.

flexibility and relaxation training [control]; progressive, aerobic exercise program; progressive, resistance exercise program

survey administration OTHER

Administered at measured at baseline, 3, 6, 12, and 18 months

flexibility and relaxation training [control]; progressive, aerobic exercise program; progressive, resistance exercise program

assessment of therapy complications PROCEDURE

Follow-up every 6 months (measured at baseline, 3, 6, 12, and 18 months )

flexibility and relaxation training [control]; progressive, aerobic exercise program; progressive, resistance exercise program

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

flexibility and relaxation training [control]; progressive, aerobic exercise program; progressive, resistance exercise program

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.

flexibility and relaxation training [control]; progressive, aerobic exercise program; progressive, resistance exercise program

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

flexibility and relaxation training [control]; progressive, aerobic exercise program; progressive, resistance exercise program

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (2)

• 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.

  PMID: 34426142 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.

  PMID: 29141853 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Breast Carcinoma In Situ

Interventions

Therapeutics; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kerri Winters-Stone, PhD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 21, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

US (1)