Cancer SurvivorNCT03039140
Cardiac Rehabilitation Program in Improving Cardiorespiratory Fitness in Stage 0-III Breast Cancer Survivors
A study testing Educational Intervention, Exercise Intervention and Quality-of-Life Assessment in people with Cancer Survivor and Stage 0 Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause of death of women in both the general population and the breast cancer survivor population. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer
- What is being tested?
- Educational Intervention, Exercise Intervention and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2015to 31 Dec 2021
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with breast cancer stages 0-III within 6 months after completion of all planned surgery, radiation and or chemotherapy treatments
- Concurrent endocrine therapy permissible
- Ability to understand and the willingness to sign a written informed consent
- Willingness to participate in CR program
Who cannot join
- Existing CVD
- Existing diabetes
- Contraindications to exercise
- Metastatic breast cancer
- Other concurrent malignancies except skin cancer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situation that would limit compliance with study requirements
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- Pregnant or nursing women
- Unable to give informed consent
- Any contraindication to cardiac stress testing
- Travel distance greater than 50 miles
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study
This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause of death of women in both the general population and the breast cancer survivor population. There are many risk factors common to both heart disease and breast cancer development, including physical inactivity. A cardiac rehabilitation program may help improve cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of life among breast cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in women with breast cancer after completion of acute therapy.
II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.
III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure, cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up. Blood pressure and body mass index will also be checked at 8 weeks.
IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week follow up, adjusting for baseline QoL values.
OUTLINE:
Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, rating of perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.
- Conditions
- Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Being tested
- Educational Intervention, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Attend weekly educational sessions
Exercise InterventionBehavioural
Participate in CR program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (CR program) | Experimental | Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, RPE, heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss. Receives: Other: Educational Intervention; Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting a 14-week CR program
During the course of the 14-week intervention period, the CR medical director will monitor CR staff adherence to the study protocol. Every 2 weeks, they will review intervention participants' baseline graded exercise test results and subsequent exercise prescriptions to ensure the intervention is targeted at the appropriate level of each participant's VO2 max. Will administer a satisfaction questionnaire to intervention participants. Results from these surveys will be evaluated during the course of the study by the principal investigator and used to improve the study process as appropriate.
Measured: 14 weeks
Secondary outcomes (1)
Efficacy of CR in improving cardiorespiratory fitness
Analysis of follow-up VO2 max, in units of mL/kg/min, will be done using an analysis of covariance (ANCOVA) approach. If VO2 max values are missing at 14 weeks, will use the Duke Activity Status Index questionnaire responses to approximate VO2 max values.
Measured: At 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start14 May 2015
- Primary completion23 Oct 2018
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Lustberg, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039140
- Sponsor's protocol ID
- OSU-14060
- Other IDs
- NCI-2015-00810
- Status last verified
- Feb 2022
- First submitted
- 7 Mar 2016
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03039140
- Acronym / sponsor ID
- OSU-14060
- Conditions
- Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 14 May 2015 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Feb 2017 (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 clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause of death of women in both the general population and the breast cancer survivor population. There are many risk factors common to both heart disease and breast cancer development, including physical inactivity. A cardiac rehabilitation program may help improve cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of life among breast cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in women with breast cancer after completion of acute therapy.
II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.
III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure, cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up. Blood pressure and body mass index will also be checked at 8 weeks.
IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week follow up, adjusting for baseline QoL values.
OUTLINE:
Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, rating of perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (CR program) | Experimental | Other: Educational Intervention, Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients participate in a CR program consisting of 1-hour CR intervention sessions, based on a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions). Components of the exercise prescription includes intensity, mode, duration, and frequency. Intensity of exercise is guided by the results of a graded exercise stress test, RPE, heart rate, and symptoms, such as chest pain/angina or shortness of breath. If exercise is well-tolerated during CR sessions, patients are encouraged to supplement their exercise program at home, increasing their exercise frequency to up to 5 times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR program which covers topics such as stress management, smoking cessation, nutrition, and weight loss. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with breast cancer stages 0-III within 6 months after completion of all planned surgery, radiation and or chemotherapy treatments
- Concurrent endocrine therapy permissible
- Ability to understand and the willingness to sign a written informed consent
- Willingness to participate in CR program
Key exclusion criteria (10 listed)
- Existing CVD
- Existing diabetes
- Contraindications to exercise
- Metastatic breast cancer
- Other concurrent malignancies except skin cancer
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention, EducationalAttend weekly educational sessions | Other | Supportive care (CR program) |
| Exercise InterventionParticipate in CR program | Behavioural | Supportive care (CR program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (CR program) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (CR program) |
Primary outcome
Feasibility of conducting a 14-week CR program
Time frame: 14 weeks
During the course of the 14-week intervention period, the CR medical director will monitor CR staff adherence to the study protocol. Every 2 weeks, they will review intervention participants' baseline graded exercise test results and subsequent exercise prescriptions to ensure the intervention is targeted at the appropriate level of each participant's VO2 max. Will administer a satisfaction questionnaire to intervention participants. Results from these surveys will be evaluated during the course of the study by the principal investigator and used to improve the study process as appropriate.
1 secondary outcome
Efficacy of CR in improving cardiorespiratory fitness
Time frame: At 14 weeks
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 10 Mar 2022.
- The JameslineLink provided by the sponsor.
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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.
Maryam Lustberg, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Exercise Intervention and Quality-of-Life Assessment in people with Cancer Survivor and Stage 0 Breast Cancer, run by Ohio State University Comprehensive Cancer Center 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 10 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 10 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 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?
Feasibility of conducting a 14-week CR program (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2022.