Anatomic Stage I Breast Cancer AJCC v8NCT04454086
Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors
A study testing Aerobic Exercise, Exercise Counseling and Nutritional Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Aerobic Exercise, Exercise Counseling and Nutritional Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 27 Jul 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
- Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
- Overweight/obese (body mass index [BMI] > 25).
- Ability to understand and the willingness to sign a written informed consent.
- Willing and physically able to participate in physical activity.
- Obtain physician consent via primary care physician and/or treating oncologist.
Who cannot join
- > 60 months post breast cancer therapy.
- Contraindications to exercise.
- Diagnosis of cancer other than breast that is receiving active treatment.
- Currently receiving chemotherapy/radiation.
- Musculoskeletal/neurological disorder inhibiting them from safe exercise.
- Pregnant or nursing women.
- Unable to give informed consent.
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: Healthy New Albany: Breast Cancer Project
This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.
II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors.
III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors.
OUTLINE:
Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.
After completion of study, patients are followed up at 3 and 6 months.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Aerobic Exercise, Exercise Counseling, Nutritional Assessment, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
Also called Aerobic Activity
Undergo aerobic exercise
Exercise CounselingOther
Receive behavioral activity counseling
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Receive nutritional counseling
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Resistance TrainingOther
Also called Strength Training
Undergo resistance exercises
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (exercise program, counseling) | Experimental | Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2. Receives: Other: Aerobic Exercise; Other: Exercise Counseling; Other: Nutritional Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility disability
Assessed with the 400-meter walk test. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the last observation carried forward (LOCF) approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Baseline up to 6 months
Secondary outcomes (11)
Self-reported physical function
Measure with the abbreviated Late-Life Function and Disability Inventory. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Baseline up to 6 months
Objective functional performance
Using 3 valid and reliable timed performance-related mobility tasks: 400-meter walk (the primary outcome), stair-climb, and lift and carry task. Assessments of Mobility-Related Self-Efficacy to complete each functional task will also be completed with the tests. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Baseline up to 6 months
Balance deficits assessment
Estimate standing and reaching balance using a balance plate. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Baseline up to 6 months
Muscular strength assessement
Using standardized one-repetition maximum testing protocols for the chest press and leg extension exercises. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Baseline up to 6 months
Body composition
Dual-energy x-ray absorptiometry (DEXA) for all outcome measures. The DEXA scans were used to determine total body composition including bone-mineral density, as well as, percentage body fat and fat-free mass for all body regions. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Baseline up to 6 months
Body weight
Measured to the nearest 0.1 kilogram using a calibrated and certified balance beam scale. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Baseline up to 6 months
Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12)
The SF-12 questionnaire is a 12 -item scale that assesses the Physical (PCS) and Mental Health (MCS) composite summary scales composed of 6 items each on a 5-point rating scale. PCS and MCS scores range from 0-30 with higher scores indicating more favorable outcomes.
Measured: Baseline up to 6 months
Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B).
The Functional Assessment of Cancer Therapy-Breast is a disease specific measures including the satisfaction with life scale. The Functional Assessment of Cancer Therapy-breast will be used to analyze sample T-tests.
Measured: Baseline up to 6 months
Brief Fatigue Inventory (BFI)
The Brief Fatigue Inventory is a 9-item scale scored on an 11-point rating scale ranging from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores represent greater levels of fatigue. In this form, there are 5 overarching questions. The first one asks, "Have you felt unusually tired or fatigued in the last week?" which is simply a Yes or No response. The next 4 questions then have answers in terms of a scale. The next 3 have the following sliding scale: 0= No Fatigue, 10= As bad as you can imagine, with 1-9 each representing intermediate responses. For the last question, the scale is: 0= Does not interfere, 10= Completely interferes, with 1-9 representing individual intermediate responses.
Measured: Baseline up to 6 months
Adherence assessment
Will be defined via attendance at prescribed sessions and will be assessed using exercise logs, upon which participants will record all exercise performed at the center or independently. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Up to 6 months
Feasibility measures
Descriptive statistics for assessments of recruitment rates, adverse events, and retention rates will be calculated prospectively throughout the trial. Feasibility assessments of participants? satisfaction with the exercise and dietary intervention will also be completed at the end of the 24-week intervention. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the LOCF approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start6 Mar 2019
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies 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
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Focht, Ohio State University Comprehensive Cancer Center
- Investigators
- Brian C Focht, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454086
- Sponsor's protocol ID
- OSU-17122
- Other IDs
- NCI-2019-00570
- Status last verified
- Apr 2024
- First submitted
- 16 Jul 2019
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy New Albany: Breast Cancer Project
- ClinicalTrials.gov ID
- NCT04454086
- Acronym / sponsor ID
- OSU-17122
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 1 Jul 2020 (actual)
- 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 trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.
II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors.
III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors.
OUTLINE:
Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.
After completion of study, patients are followed up at 3 and 6 months.
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 (exercise program, counseling) | Experimental | Other: Aerobic Exercise, Other: Exercise Counseling, Other: Nutritional Assessment, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Resistance TrainingPatients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
- Overweight/obese (body mass index [BMI] > 25).
- Ability to understand and the willingness to sign a written informed consent.
- Willing and physically able to participate in physical activity.
- Obtain physician consent via primary care physician and/or treating oncologist.
Key exclusion criteria (7 listed)
- > 60 months post breast cancer therapy.
- Contraindications to exercise.
- Diagnosis of cancer other than breast that is receiving active treatment.
- Currently receiving chemotherapy/radiation.
- Musculoskeletal/neurological disorder inhibiting them from safe exercise.
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 |
|---|---|---|
| Aerobic ExerciseAlso: Aerobic ActivityUndergo aerobic exercise | Other | Supportive care (exercise program, counseling) |
| Exercise CounselingReceive behavioral activity counseling | Other | Supportive care (exercise program, counseling) |
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingReceive nutritional counseling | Other | Supportive care (exercise program, counseling) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (exercise program, counseling) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (exercise program, counseling) |
| Resistance TrainingAlso: Strength TrainingUndergo resistance exercises | Other | Supportive care (exercise program, counseling) |
Primary outcome
Mobility disability
Time frame: Baseline up to 6 months
Assessed with the 400-meter walk test. Will be analyzed using paired samples t-tests. Statistical significance will be assumed at p =< 0.05, and results will be based on two-tailed statistical tests. Mean change from baseline, paired sample t-test, and effect size estimates will be calculated for each outcome measure. Analyses will be conducted using the intent-to-treat principle to account for missing data with the last observation carried forward (LOCF) approach, used to impute change across time to be zero. Additionally, effect sizes (Cohen?s d) will be calculated by taking the mean difference and dividing by the pooled standard deviation to determine the magnitude of differences observed for each outcome.
11 secondary outcomes
Self-reported physical function
Time frame: Baseline up to 6 months
Objective functional performance
Time frame: Baseline up to 6 months
Balance deficits assessment
Time frame: Baseline up to 6 months
Muscular strength assessement
Time frame: Baseline up to 6 months
Body composition
Time frame: Baseline up to 6 months
Body weight
Time frame: Baseline up to 6 months
Quality of life (QOL) surveys using the Rand Short Form Health Survey (SF-12)
Time frame: Baseline up to 6 months
Quality of life (QOL) survey using the Functional Assessment of Cancer Therapy- breast (FACT-B).
Time frame: Baseline up to 6 months
Brief Fatigue Inventory (BFI)
Time frame: Baseline up to 6 months
Adherence assessment
Time frame: Up to 6 months
Feasibility measures
Time frame: Up to 24 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 2 Apr 2024.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anatomic Stage I Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2
Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Recruiting
Researching the Effect of Exercise on Cancer
Breast Cancer, Prostate Cancer
RecruitingPhase 2
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
RecruitingPhase 1/2
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
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.
Brian C Focht, PhD 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 Aerobic Exercise, Exercise Counseling and Nutritional Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, 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 5 inclusion and 7 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 2 Apr 2024. 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?
Mobility disability (time frame: Baseline up to 6 months). 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 2 Apr 2024.