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The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02079662
First received: March 4, 2014
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The goal of this behavioral research study is to look at the relationship between lifestyle factors and cancer-related outcomes, such as the risk of the disease coming back, patient quality of life, physical functioning, and bodily reactions (such as hormones and immune function).


Condition Intervention
Breast Cancer
Behavioral: Aerobic Activity
Behavioral: Dietician Counseling
Behavioral: Yoga
Behavioral: Cognitive Behavior Therapy
Behavioral: Smoking Cessation Counseling
Behavioral: Questionnaires
Other: Saliva Samples
Behavioral: Dietary Assessment
Procedure: Blood Samples

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Disease-Free Survival (DFS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Primary endpoint of study, disease-free survival (DFS), analyzed using a multivariate comparison of DSF for each group using a Cox proportional hazards analysis. The following considered as potential covariates in analysis (tumor and nodal status, menopausal status at diagnosis, tumor factors, treatment regimen, etc). For the Integrative Oncology (IO) group, we will determine compliance with practice. Changes in diet, physical activity, and stress management practices assessed in both groups. Exploratory analysis will examine change in lifestyle as a mediator of clinical, biological, and patient reported outcomes.


Estimated Enrollment: 160
Study Start Date: June 2013
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intergrative Oncology Group (IO)
Baseline measures collected prior to start of radiotherapy. Assessment includes battery of questionnaires. Saliva samples collected 4 times a day for 3 days in a row at baseline and in follow up. At baseline and follow ups, blood drawn to measure hormones and immune system responses. Accelerometer worn for 5 days. Within 2 weeks of consent date, participant contacted by telephone on 3 random days for a dietary recall. Participants have up to 7 different intervention sessions per week during course of radiotherapy for between 1 and 2 hours each session, up to 6 aerobic training sessions per week and one grocery store trip. Participants have a weekly meeting on the computer for 6 months, followed by a monthly meeting on computer from 6-12 months, and 2 hour meetings at all follow-up appointments during first year after radiotherapy. Follow-up assessments will take place during the last week of radiotherapy (+/- 2 weeks), and 2-4, 5-7, 11-13, 17-19, 23-25, 35-37, 47-49, and 59-61 months.
Behavioral: Aerobic Activity
30-60 minutes of moderate-to-vigorous intensity aerobic activity up to 6 days/week.
Behavioral: Dietician Counseling
Weekly meeting with dietician during radiotherapy to learn how to shop and cook during radiation therapy.
Behavioral: Yoga
Yoga based biweekly sessions with a mind-body instructor for about an hour.
Behavioral: Cognitive Behavior Therapy
Participants meet with a psychologist once a week during radiation treatment, during which time they take part in cognitive behavioral therapy to help support behavior changes.
Behavioral: Smoking Cessation Counseling
Smoking cessation treatment offered if participant smokes.
Behavioral: Questionnaires
Questionnaire completion at baseline, at end of radiation treatment, and at 3, 6, 12, 18, and 24 months after the end of radiation treatment, and then once a year for up to 3 years. This should take about 60-80 minutes.
Other Name: Surveys
Other: Saliva Samples
Saliva samples collected 4 times a day for 3 days in a row at baseline and in follow up.
Behavioral: Dietary Assessment
Within 2 weeks of consent date, participant contacted by telephone on 3 random days for a dietary recall.
Procedure: Blood Samples
At baseline and follow ups, blood drawn to measure hormones and immune system responses.
Active Comparator: Standard of Care (SC)
Baseline measures from participants collected prior to the start of radiotherapy. Assessment includes 60 to 90 minute-long battery of questionnaires. Saliva samples collected 4 times a day for 3 days in a row at baseline and in follow up. Within 2 weeks of consent date, participant contacted by telephone on 3 random days for a dietary recall. Follow-up assessments take place during the last week of radiotherapy (+/- 2 weeks), and 2-4, 5-7, 11-13, 17-19, 23-25, 35-37, 47-49, and 59-61 months. At baseline and follow ups, blood drawn to measure hormones and immune system responses.
Behavioral: Questionnaires
Questionnaire completion at baseline, at end of radiation treatment, and at 3, 6, 12, 18, and 24 months after the end of radiation treatment, and then once a year for up to 3 years. This should take about 60-80 minutes.
Other Name: Surveys
Other: Saliva Samples
Saliva samples collected 4 times a day for 3 days in a row at baseline and in follow up.
Behavioral: Dietary Assessment
Within 2 weeks of consent date, participant contacted by telephone on 3 random days for a dietary recall.
Procedure: Blood Samples
At baseline and follow ups, blood drawn to measure hormones and immune system responses.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with Stage III breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy.
  2. Participants must be able to read, write, and speak English.
  3. Participants must be at least 18 years of age.
  4. Participants must be oriented to person, place, and time.
  5. Participants must also meet 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. They must also have a BMI of 25 or higher at time of consent as assessed in the medical record.

Exclusion Criteria:

  1. Patients with a recurrent breast cancer diagnosis.
  2. Patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers.
  3. Patients who have any major psychiatric diagnoses or thought disorder (e.g. Schizophrenia, Bi-polar disorder, Dementia).
  4. Patients with communication barriers (e.g., hard of hearing).
  5. Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted).
  6. Patients with poorly or uncontrolled diabetes in the opinion of the physician(s).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079662

Contacts
Contact: Lorenzo Cohen, PHD 713-745-4260

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lorenzo Cohen, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02079662     History of Changes
Other Study ID Numbers: 2012-0112
Study First Received: March 4, 2014
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Radiation Therapy
Radiotherapy
XRT
Aerobic Activity
Dietician Counseling
Dietary Assessment
Yoga
Cognitive Behavior Therapy
Smoking Cessation Counseling
Questionnaires
Surveys
Saliva Samples
Blood Samples

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014