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Breast CancerNCT02763228

Physical Activity Intervention to Reduce Functional Health Disparities Among Breast Cancer Survivors

A study testing Aerobic Training - Fixed Schedule, Resistance Training - Fixed Schedule and Walking program in people with Breast Cancer and Physical Activity, run by Case Comprehensive Cancer Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to determine whether a physical activity (exercise) program in the community will improve the functional and overall health status of older women with a history of breast cancer. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Breast Cancer, Physical Activity
What is being tested?
Aerobic Training - Fixed Schedule, Resistance Training - Fixed Schedule and Walking program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
3 sitesUnited States
Study dates
16 Mar 2016to 6 Nov 2020
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 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Pathologically confirmed breast cancer
  • Stage I-III
  • Patients who have completed treatment but are within five years of treatment completion (primary surgery, chemotherapy or radiation therapy), whichever was received last. Hormonal therapy and targeted therapy are allowed
  • Race: African-Americans and Non-Hispanic Whites

Who cannot join

  • Stage IV breast cancer
  • Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
  • Inability to understand English as study instruments have not been validated in other languages
  • Inability to provide informed consent
  • High-risk patients (as defined by the American College of Sports Medicine risk-stratification schema using the American College of Sports Medicine (ACSM)/American Heart Association exercise pre-participation questionnaire) who do not receive clearance from cardiology
  • Other medical or psychological conditions that would make participation unsafe or inhibit our ability to test our primary hypothesis, e.g. Parkinson's disease, severe dementia.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Metro Health Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: A Physical Activity Intervention to Reduce Functional Health Disparities Among Older Breast Cancer Survivors

The purpose of this research study is to determine whether a physical activity (exercise) program in the community will improve the functional and overall health status of older women with a history of breast cancer. The physical activity or exercise program is designed for all older breast cancer survivors, and in particular for African-Americans and women of lower socio-economic status, who are the least likely to engage in physical activity.

Read the detailed description

Specific Aim #1: To determine the effect of a refined and culturally-sensitive physical activity intervention on functional outcomes at 20 and 52 weeks among older Breast Cancer survivors who are within five years of treatment completion for stage I-III Breast Cancer (BCa).

Specific Aim #2: To examine whether race and socioeconomic status (SES) moderate the intervention effect on physical activity (PA) levels and functional outcomes at 20 and 52 weeks.

Specific Aim #3: To examine the effect of the PA intervention on longitudinal changes in beliefs, attitudes and preferences (KAPs) and PA levels, and the extent to which changes in these factors mediate intervention effect on functional outcomes.

Specific Aim #4: To determine the effect of the PA intervention on surrogate biomarkers associated with breast cancer prognosis and functional disability.

Being tested
Aerobic Training - Fixed Schedule, Resistance Training - Fixed Schedule, Walking program, Aerobic Training - Flexible Schedule, Resistance Training - Flexible Schedule
Keywords
Physical Activity, Breast Cancer, minority, African American
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic Training - Fixed ScheduleBehavioural

    Also called Aerobic exercise

    Supervised aerobic training for 40 minutes 3x/week for 20 weeks

  • Resistance Training - Fixed ScheduleBehavioural

    Supervised resistance training for 20 minutes 3x/week for 20 weeks

  • Walking programBehavioural

    Unsupervised walking program 1-3 days/week for 52 weeks

  • Aerobic Training - Flexible ScheduleBehavioural

    Supervised aerobic training done on the participant's own schedule for 32 weeks

  • Resistance Training - Flexible ScheduleBehavioural

    Supervised resistance training done on the participant's own schedule for 32 weeks

  • Successful Survivorship Health Education and Support GroupBehavioural

    Also called Structured Support Group

    Support groups will be held for one hour 3x/week for 20 weeks. Topics will include, but are not limited, to long-term side effects of treatment, stress management, coping with fear and uncertainty, body image, sexuality, and spirituality.

  • Flexible support groupsBehavioural

    Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.

Study groups in NCT02763228
Study groupRoleWhat they receive
Group 1: Exercise ProgramExperimentalThe exercise in this study will consist of two types of exercise training: resistance training and aerobic exercise. Resistance training is like "weight lifting" to improve strength and function. Participants will complete resistance training by using resistance machines and free weights. Aerobic exercise is exercise that intends to improve the cardiopulmonary or oxygen/lung and heart systems. It is often referred to as "cardio" exercise. Treadmill walking, stationary cycling sessions, and/or other exercises will be used for aerobic exercise. Participants will be instructed in the exercise routine by physical fitness experts and trainers.
Receives: Behavioral: Aerobic Training - Fixed Schedule; Behavioral: Resistance Training - Fixed Schedule; Behavioral: Walking program; Behavioral: Aerobic Training - Flexible Schedule; Behavioral: Resistance Training - Flexible Schedule
Group 2: Support GroupActive comparatorFirst 20 Weeks: Participants will take part in a structured Health Education and Support Group sessions once a week. Last 32 weeks: Participants will be encouraged to take part in any of the Support Group sessions offered regularly on their own schedule.
Receives: Behavioral: Successful Survivorship Health Education and Support Group; Behavioral: Flexible support groups

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical performance scores based on the Short Physical Performance Battery (SPPB)

    Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.

    Measured: baseline to 20 weeks

Secondary outcomes (3)

  1. Change in SPPB scores

    Change in physical performance will be ascertained using the Short Physical Performance Battery (SPPB). Summary scores range from 0-12 and higher scores denote higher physical performance.

    Measured: baseline to 52 weeks

  2. Change in Activities of daily living (ADL) score

    Summary scores for ADL range from 0-14 and higher scores denote higher functional status.

    Measured: baseline to 20 weeks

  3. Change in Activities of daily living (ADL) score

    Summary scores for ADL range from 0-14 and higher scores denote higher functional status.

    Measured: baseline to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2016 (estimated)
  2. Study start16 Mar 2016
  3. Primary completion25 Mar 2020
  4. Study completion6 Nov 2020

Resources

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
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02763228
Sponsor's protocol ID
CASE2116
Status last verified
Mar 2022
First submitted
27 Apr 2016
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hundal J, Williams D, Nock NL, Austin K, Bennet E, Cerne S, Moore HCF, Petkac J, Schmitz KH, Berger NA, Owusu C. Older breast cancer survivors' exercise and support group program experiences and recommendations from the IMPROVE trial: a qualitative study. BMC Cancer. 2026 Jan 6;26(1):181. doi: 10.1186/s12885-025-15425-w.

    PubMed 41495697

  • Owusu C, Margevicius S, Nock NL, Austin K, Bennet E, Cerne S, Hergenroeder P, Moore HCF, Petkac J, Schluchter M, Schmitz KH, Webb Hooper M, Wimbley L, Berger NA. A randomized controlled trial of the effect of supervised exercise on functional outcomes in older African American and non-Hispanic White breast cancer survivors: Are there racial differences in the effects of exercise on functional outcomes? Cancer. 2022 Jun 15;128(12):2320-2338. doi: 10.1002/cncr.34184. Epub 2022 Mar 15.

    PubMed 35289926

  • Owusu C, Nock NL, Feuntes V, Margevicius S, Hergenroeder P, Austin K, Bennet E, Cerne S, Moore HCF, Petkac J, Schluchter M, Schmitz KH, Webb Hooper M, Coccia S, Nagy C, Wimbley L, Berger NA. IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and Non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Recruitment strategies and baseline characteristics. Cancer. 2021 Jun 1;127(11):1836-1846. doi: 10.1002/cncr.33430. Epub 2021 Feb 4.

    PubMed 33539554

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Training - Fixed Schedule, Resistance Training - Fixed Schedule and Walking program in people with Breast Cancer and Physical Activity, run by Case Comprehensive Cancer Center at 3 sites 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 6 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Change in physical performance scores based on the Short Physical Performance Battery (SPPB) (time frame: baseline to 20 weeks). 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 NCT02763228, which also lists 3 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 22 Mar 2022.

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