Malignant NeoplasmGET FITNCT01635413
Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
A study testing Exercise Intervention and Questionnaire Administration in people with Malignant Neoplasm and Postmenopausal, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Malignant Neoplasm, Postmenopausal
- What is being tested?
- Exercise Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the relative efficacy of tai chi and strength training to prevent falls in female cancer survivors.
II. Determine the mechanism by which tai chi and strength training each reduces the risk of falls.
III. Determine how well the benefits of each intervention persist after structured training stops.
SECONDARY OBJECTIVE:
- Evaluate the effect of the intervention on physical functioning.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients attend strength training classes for 1 hour 2 days per week.
ARM II: Patients attend tai chi classes for 1 hour 2 days per week.
ARM III: Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.
In all arms, treatment continues for 6 months.
After completion of study treatment, patients are followed up for 6 months.
- Conditions
- Malignant Neoplasm, Postmenopausal
- Being tested
- Exercise Intervention, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Undergo strength training classes
Exercise InterventionBehavioural
Undergo tai chi classes
Exercise InterventionBehavioural
Undergo stretching and relaxation classes
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (strength training) | Experimental | Patients attend strength training classes for 1 hour 2 days per week. Receives: Behavioral: Exercise Intervention; Other: Questionnaire Administration |
| Arm II (tai chi) | Experimental | Patients attend tai chi classes for 1 hour 2 days per week. Receives: 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. Receives: Behavioral: Exercise Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 12 months
Secondary outcomes (5)
Muscle strength
Measured by 1-repetition maximum (1-RM) for leg press. The maximum amount of weight that can be lifted one time.
Measured: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment
Postural stability
Measured by Computerized dynamic posturography using the sensory organization test (SOT) and limits of stability (LOS). The SOT generates an equilibrium scores and sensory ratios that range from 0-100, where 100 = perfect stability and 0 = an inability to maintain balance and a fall. The LOS measures the average % of targeted distances reached (end point excursion) and average % of movement in the targeted direction (directional control).
Measured: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment
Flexibility
Measured by the standardized chair sit-and-reach test for lower body flexibility. Designed for older adults with demonstrated validity and reliability in older adults (test-retest 0.95-0.96).
Measured: Baseline, 3 and 6 months during study treatment and 6 months after completion of study
Physical Function
Measured by the Physical Performance Battery (PPB). The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.
Measured: Baseline, 3 and 6 months during study treatment and 6 months after completion of study
Injurious falls
Collected during prospective monthly and quarterly reports of falls. A fall is considered ''injurious'' if it results in fractures, head injuries, sprains, bruises, scrapes, or serious joint injuries, or if the participant seeks medical care.
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kerri Winters, OHSU Knight Cancer Institute
- Investigators
- Kerri Winters-Stone, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635413
- Sponsor's protocol ID
- IRB00008560
- Other IDs
- NCI-2012-01141, MR00045870, CPC-12080-LX, IRB00008560, R01CA163474
- Acronym
- GET FIT
- Status last verified
- Sep 2021
- First submitted
- 29 Jun 2012
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40721864Winters-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.
PubMed 38642204Winters-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.
PubMed 37379504Winters-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.
PubMed 36888933McGinnis 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.
PubMed 36441715Winters-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.
PubMed 23217054
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial)
- ClinicalTrials.gov ID
- NCT01635413
- Acronym / sponsor ID
- GET FIT / IRB00008560
- Conditions
- Malignant Neoplasm, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Compare the relative efficacy of tai chi and strength training to prevent falls in female cancer survivors.
II. Determine the mechanism by which tai chi and strength training each reduces the risk of falls.
III. Determine how well the benefits of each intervention persist after structured training stops.
SECONDARY OBJECTIVE:
- Evaluate the effect of the intervention on physical functioning.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients attend strength training classes for 1 hour 2 days per week.
ARM II: Patients attend tai chi classes for 1 hour 2 days per week.
ARM III: Patients attend supervised stretching and relaxation classes for 1 hour 2 days per week.
In all arms, treatment continues for 6 months.
After completion of study treatment, patients are followed up for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (strength training) | Experimental | Behavioral: Exercise Intervention, Other: Questionnaire AdministrationPatients attend strength training classes for 1 hour 2 days per week. |
| Arm II (tai chi) | Experimental | Behavioral: Exercise Intervention, Other: Questionnaire AdministrationPatients attend tai chi classes for 1 hour 2 days per week. |
| Arm III (control) | Active comparator | Behavioral: Exercise Intervention, Other: Questionnaire AdministrationPatients attend supervised stretching and relaxation classes for 1 hour 2 days per week. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionUndergo strength training classes | Behavioural | Arm I (strength training) |
| Exercise InterventionUndergo tai chi classes | Behavioural | Arm II (tai chi) |
| Exercise InterventionUndergo stretching and relaxation classes | Behavioural | Arm III (control) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (strength training), Arm II (tai chi), Arm III (control) |
Primary outcome
Falls
Time frame: Baseline up to 12 months
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.
5 secondary outcomes
Muscle strength
Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment
Postural stability
Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study treatment
Flexibility
Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study
Physical Function
Time frame: Baseline, 3 and 6 months during study treatment and 6 months after completion of study
Injurious falls
Time frame: Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Derived from this study: PubMed 40721864Sitemba 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.
- Derived from this study: PubMed 38642204Winters-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.
- Derived from this study: PubMed 37379504Winters-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.
- Derived from this study: PubMed 36888933Winters-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.
- Derived from this study: PubMed 36441715McGinnis 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.
- Derived from this study: PubMed 23217054Winters-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Winters-Stone principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Questionnaire Administration in people with Malignant Neoplasm and Postmenopausal, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls (time frame: Baseline up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635413, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021; AzTrials last refreshed its copy on 2 Nov 2026.