Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)

NCT01635413 | Completed DMC

• 5 other identifiers: IRB00008560NCI-2012-01141MR00045870CPC-12080-LXR01CA163474
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to compare the physical and quality of life benefits of two different types of exercise- tai chi versus strength training- for female cancer survivors who have had chemotherapy. Each exercise- tai chi and strength training- will be compared to participants in a group that performs flexibility and relaxation exercises, which is expected to have different benefits than either tai chi or strength training.

Conditions

Malignant Neoplasm; Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Falls

  Prospective assessment of falls will be done by collecting monthly and quarterly reports returned by postal and/or electronic mail. A fall is defined as unintentionally coming to rest on the ground or at some other lower level, not as a result of a major intrinsic event (e.g., stroke or syncope) or overwhelming hazard.

  Baseline up to 12 months

Secondary Outcomes (5)

• Muscle strength

  Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment

• Postural stability

  Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment

• Flexibility

  Baseline, 3 and 6 months during study treatment and 6 months after completion of study

• Physical Function

  Baseline, 3 and 6 months during study treatment and 6 months after completion of study

• Injurious falls

  Baseline up to 12 months

Study Arms (3)

Arm I (strength training)

EXPERIMENTAL

Patients attend strength training classes for 1 hour 2 days per week.

Behavioral: Exercise Intervention; Other: Questionnaire Administration

Arm II (tai chi)

EXPERIMENTAL

Patients attend tai chi classes for 1 hour 2 days per week.

Behavioral: Exercise Intervention; Other: Questionnaire Administration

Arm III (control)

ACTIVE COMPARATOR

Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.

Behavioral: Exercise Intervention; Other: Questionnaire Administration

Interventions

Exercise Intervention BEHAVIORAL

Undergo strength training classes

Arm I (strength training)

Questionnaire Administration OTHER

Ancillary studies

Arm I (strength training); Arm II (tai chi); Arm III (control)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with stage I-III cancer other than cancers of the brain or spinal cord (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm either the site of her cancer or that her stage of cancer is \< stage IV, we will send a letter to her physician to confirm this criterion)
• Completed chemotherapy \> 3 months prior to enrollment and no concurrent adjuvant therapy other than hormone manipulation therapy for breast cancer (confirmed by patient self-report on the Health History Questionnaire; if patient is unable to confirm whether or not she completed chemotherapy 3 months prior to enrollment, we will send a letter to her physician to confirm eligibility on this criterion)
• Postmenopausal (confirmed by self-report on the Health History Questionnaire; menopausal status could also be confirmed by a recent \[\< 6 months from enrollment\] laboratory report documenting serum follicle-stimulating hormone \[FSH\] \> 30 mIU/ml and/or serum estradiol \< 30 pg/ml)
• Currently underactive (\< 60 minutes of moderate intensity exercise per week in the last month) (confirmed by self-report on the Health History Questionnaire)

You may not qualify if:

• Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent (confirmed by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone)
• A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible)

Sponsors & Collaborators

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

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (6)

• Sitemba J, Crisafio M, Li F, Eckstrom E, Winters-Stone KM. Evaluating recruitment, retention, and adherence patterns in the GET FIT fall prevention exercise trial in older, postmenopausal cancer survivors. Support Care Cancer. 2025 Jul 28;33(8):727. doi: 10.1007/s00520-025-09767-1.

  PMID: 40721864 DERIVED

• Winters-Stone KM, Stoyles SA, Dieckmann NF, Eckstrom E, Luoh SW, Horak FB, Roeland EJ, Li F. Can strength training or tai ji quan training reduce frailty in postmenopausal women treated with chemotherapy? A secondary data analysis of the GET FIT trial. J Cancer Surviv. 2024 Aug;18(4):1179-1189. doi: 10.1007/s11764-024-01592-5. Epub 2024 Apr 20.

  PMID: 38642204 DERIVED

• Winters-Stone KM, Roeland EJ, Li F, Eckstrom E, Horak F, Dieckmann NF, Stoyles SA, Luoh SW. Reply to Y.-T. Hu et al. J Clin Oncol. 2023 Sep 10;41(26):4316-4317. doi: 10.1200/JCO.23.01034. Epub 2023 Jun 28. No abstract available.

  PMID: 37379504 DERIVED

• Winters-Stone KM, Horak F, Dieckmann NF, Luoh SW, Eckstrom E, Stoyles SA, Roeland EJ, Li F. GET FIT: A Randomized Clinical Trial of Tai Ji Quan Versus Strength Training for Fall Prevention After Chemotherapy in Older, Postmenopausal Women Cancer Survivors. J Clin Oncol. 2023 Jun 20;41(18):3384-3396. doi: 10.1200/JCO.22.01519. Epub 2023 Mar 8.

  PMID: 36888933 DERIVED

• McGinnis GJ, Holden S, Yu B, Ransom C, Guidarelli C, De B, Diao K, Boyce D, Thomas CR Jr, Winters-Stone K, Raber J. Association of fall rate and functional status by APOE genotype in cancer survivors after exercise intervention. Oncotarget. 2022 Nov 17;13:1259-1270. doi: 10.18632/oncotarget.28310.

  PMID: 36441715 DERIVED

• Winters-Stone KM, Li F, Horak F, Luoh SW, Bennett JA, Nail L, Dieckmann N. Comparison of tai chi vs. strength training for fall prevention among female cancer survivors: study protocol for the GET FIT trial. BMC Cancer. 2012 Dec 5;12:577. doi: 10.1186/1471-2407-12-577.

  PMID: 23217054 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kerri Winters-Stone

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 9, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

US (1)