The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02079662 |
|
Recruitment Status :
Active, not recruiting
First Posted : March 6, 2014
Last Update Posted : May 11, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 Stage IIIC Breast Cancer AJCC v7 | Other: Behavioral, Psychological or Informational Intervention Other: Best Practice Other: Cognitive Intervention Other: Computer-Assisted Intervention Other: Counseling Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration | Not Applicable |
PRIMARY OBJECTIVES:
I. 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:
I. 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Integrative Oncology Program in Improving Cancer-Related Outcomes in Patients With Stage II or III Breast Cancer Undergoing Radiation Therapy |
| Actual Study Start Date : | June 13, 2013 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm I (IO interventions)
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.
|
Other: Behavioral, Psychological or Informational Intervention
Undergo IO intervention Other: Cognitive Intervention Undergo IO intervention Other: Computer-Assisted Intervention Undergo IO intervention Other: Counseling Undergo counseling
Other Name: Counseling Intervention Behavioral: Exercise Intervention Undergo IO intervention Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
|
Active Comparator: Arm II (standard of care)
Patients undergo standard of care.
|
Other: Best Practice
Undergo standard of care
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- Disease-free survival (DFS) [ Time Frame: Up to 5 years ]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.
- Changes in biological pathways [ Time Frame: Baseline to 5 years ]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.
- Changes in dietary patterns [ Time Frame: Baseline to 5 years ]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.
- Changes in fitness levels [ Time Frame: Baseline to 5 years ]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.
- Changes in heart rate variability [ Time Frame: Baseline to 5 years ]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.
- Changes in quality of life (including fatigue and sleep disturbances) [ Time Frame: Baseline to 5 years ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079662
| United States, Texas | |
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Lorenzo Cohen | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02079662 |
| Other Study ID Numbers: |
2012-0112 NCI-2014-02449 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2012-0112 ( Other Identifier: M D Anderson Cancer Center ) |
| First Posted: | March 6, 2014 Key Record Dates |
| Last Update Posted: | May 11, 2023 |
| Last Verified: | May 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |