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The Role of Lifestyle Factors in Breast Cancer-Related Outcomes

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ClinicalTrials.gov Identifier: NCT02079662
Recruitment Status : Recruiting
First Posted : March 6, 2014
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
Actual Study Start Date : June 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Integrative 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.




Primary Outcome Measures :
  1. Disease-Free Survival (DFS) [ Time Frame: Baseline up to 5 years ]
    Disease-free survival (time to recurrence) where DFS is defined as the time from baseline (start of treatment) until the date on which disease recurrence/progression or death from any cause was documented (whichever occurred first).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with Stage II or 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.
  6. Participants must have a BMI of 24.45 or higher 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).

Information from the National Library of Medicine

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


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
Contact: MD Anderson Cancer Center    877-632-6789      
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lorenzo Cohen, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02079662     History of Changes
Other Study ID Numbers: 2012-0112
NCI-2014-02449 ( Registry Identifier: NCI CTRP )
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs