Stage II Breast Cancer AJCC v6 and v7NCT02079662

The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

A study testing Behavioral, Psychological or Informational Intervention, Best Practice and Cognitive Intervention in people with Stage II Breast Cancer AJCC v6 and v7 and Stage IIA Breast Cancer AJCC v6 and v7, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
What is being tested?: Behavioral, Psychological or Informational Intervention, Best Practice and Cognitive Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 13 Jun 2013to 31 Dec 2030
Phase: Interventional

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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women with stage II or III breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy
Participants must be able to read, write, and speak English
Participants must be oriented to person, place, and time
Participants must also meet at least two of the following criteria related to lifestyle: 1) consume less than 3 servings of fruit and vegetable/day; 2) engage in less than 75 minutes moderate/vigorous activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling); and 3) engage in a mind-body practice less than 4 times a month
Participants must have a body mass index (BMI) of 24.45 or higher as assessed in the medical record

Who cannot join

Patients with a recurrent breast cancer diagnosis
Patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers
Patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia)
Patients with communication barriers (e.g., hard of hearing)
Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted)
Patients with poorly or uncontrolled diabetes in the opinion of the physician(s)

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Integrative Oncology Program in Improving Cancer-Related Outcomes in Patients With Stage II or III Breast Cancer Undergoing Radiation Therapy

This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.

Read the detailed description

PRIMARY OBJECTIVES:

Determine whether the Integrative Oncology group (IO) has increased disease-free survival (time to recurrence) than the standard of care control group (SC).

II. Compare group differences over time in biological pathways including: immune function, endocrine function, insulin and glucose metabolism, cancer-related pathways (from peripheral blood), antioxidant capacity, and nutrient levels.

III. Examine group differences in overall survival. IV. Compare group differences over time in dietary patterns and fitness levels. V. Determine whether the IO group has improved patient reported outcomes including fatigue, sleep disturbances, radiotherapy toxicity (dermatitis, skin ulceration, pruritis, etc.), gut microbiome, other aspects of Quality of Life (QOL), mental health, social support, and measures of positive growth.

VI. Compare group differences over time in heart rate variability. VII. Determine cost-effectiveness analysis and work and/or home productivity.

SECONDARY OBJECTIVES:

Compare group differences over time in healthy breast tissue biomarkers acquired from fine needle aspirations.

II. Compare group differences in spouse or caregiver work productivity.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy.

ARM II: Patients undergo standard of care.

After completion of study treatment, patients are followed up at 6 and 12 months and then annually for up to 4 years.

Conditions: Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7
Being tested: Behavioral, Psychological or Informational Intervention, Best Practice, Cognitive Intervention, Computer-Assisted Intervention, Counseling
Medical subject headings: Breast Neoplasms

What participants receive

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

Behavioral, Psychological or Informational InterventionOther
Undergo IO intervention
Best PracticeOther
Also called standard of care, standard therapy
Undergo standard of care
Cognitive InterventionOther
Undergo IO intervention
Computer-Assisted InterventionOther
Undergo IO intervention
CounselingOther
Also called Counseling Intervention
Undergo counseling
Exercise InterventionBehavioural
Undergo IO intervention
Laboratory Biomarker AnalysisOther
Correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT02079662
Study group	Role	What they receive
Arm I (IO interventions)	Experimental	Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy. Receives: Other: Behavioral, Psychological or Informational Intervention; Other: Cognitive Intervention; Other: Computer-Assisted Intervention; Other: Counseling; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (standard of care)	Active comparator	Patients undergo standard of care. Receives: Other: Best Practice; Other: Laboratory Biomarker Analysis; 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.

Disease-free survival (DFS)
Will analyze DFS, using a multivariate comparison of DFS for each group using a Cox proportional hazards analysis. Will consider the following as potential covariates in the analysis (tumor and nodal status, menopausal status at diagnosis, tumor factors, treatment regimen, etc). Will obtain estimates for hazards ratios and 95% confidence intervals for the effect of the study arm and each covariate.
Measured: Up to 5 years
Changes in biological pathways
Will use generalized linear mixed model regression (GLMM). Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions.
Measured: Baseline to 5 years
Changes in dietary patterns
Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions.
Measured: Baseline to 5 years
Changes in fitness levels
Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions.
Measured: Baseline to 5 years
Changes in heart rate variability
Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions.
Measured: Baseline to 5 years
Changes in quality of life (including fatigue and sleep disturbances)
Will use GLMM. Separate sets of analyses will be conducted for each criterion variable. To select the best method for modeling the repeated measures, will use the methods of Wolfinger and statistics such as Akaike's and Schwarz's information criteria. Will also use either t tests or Wilcoxon two-sample tests to analyze these data, depending on their distributions.
Measured: Baseline to 5 years

Timeline

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

13 Jun 201331 Dec 2030

First posted6 Mar 2014 (estimated)
Study start13 Jun 2013
Primary completion31 Dec 2030 (estimated)
Study completion31 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage II Breast Cancer AJCC v6 and v7Studies of the same condition, open and under way.
More trials run by M.D. Anderson 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02079662
Sponsor's protocol ID: 2012-0112
Other IDs: NCI-2014-02449, 2012-0112
Status last verified: Jun 2026
First submitted: 4 Mar 2014
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Electroacupuncture Therapy in Reducing Chronic Pain in Patients After Breast Cancer Treatment
Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingPhase 2
Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7
Recruiting
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
Estrogen Receptor Negative, HER2 Positive Breast Carcinoma
Active, not recruitingPhase 3
Breast Cancer WEight Loss Study (BWEL Study)
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma

All Stage II Breast Cancer AJCC v6 and v7 trials