Clinical Trials Logo

Clinical Trial Summary

The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs.

This is an investigational study. The relaxation programs are being compared for research purposes only.

An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires.

Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.

Clinical Trial Description

During the first visit, you will fill out questionnaires that ask about your sleeping habits, how you have been feeling, and the general quality of your life. This should take about 60-80 minutes.

Every day for the next 7 days, you will fill out a diary about your sleep. You will also wear an "actigraph" wrist watch 24 hours a day for these 7 days. The watch will collect data about your physical activity and sleeping habits.

You will also have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) which will last about 10 minutes.

Study Groups:

After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:

- Group 1 will take part in one type of relaxation program.

- Group 2 will take part in another type of relaxation program.

- Group 3 will not take part in either program but will complete some of the follow-up procedures. Participants in this group will be given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet.

You will have about a 1 out of 3 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.


Groups 1 and 2:

You will take part in 3 sessions each week for the 6 weeks of radiation therapy, or 4-5 sessions each week for 4 weeks if your radiation therapy lasts only 4 weeks. You can choose any weekday (Monday through Friday). Each session should last about 60 minutes.

The sessions will be taught by an experienced, trained instructor, usually in groups of 2-5 participants. The movements are designed to be easy to follow. You will be able to work at your own pace.

Each session will be audio and video recorded. This is so the researchers can keep track of the quality of the sessions. The audio and video files are digital and will be deleted after all the data are studied.

Women in Groups 1 and 2 will be randomized to a maintenance intervention arm or a usual contact arm after the end of radiotherapy. If you are randomized to the maintenance intervention arm you will receive telephone counseling once a month after the end of your radiotherapy. You will also receive booster sessions once every 3 months post-radiotherapy, or at least when you come for your follow-up appointments.

Groups 1 and 2:

During the sessions, you will do simple stretching exercises, specific breathing skills, and guided relaxation. You will be asked to try and practice once a day for 12 months. You will be provided a DVD and an audio CD to help with your practice when you are not at the hospital.

Questionnaires and Study Procedures:

Groups 1 and 2:

Before your first session of the week except for week 1, Groups 1 and 2 will fill out a questionnaire about the relaxation program. This should take about 1-2 minutes.

During the middle of your radiation treatment period, you will have an ECG recorded before and after your classes. Each ECG will last about 10 minutes.

All Groups:

During the middle of your radiation treatment period, you will fill out a questionnaire that asks about any symptoms you may be having. This should take about 15 minutes. You will also have an ECG.

During your last week of radiation therapy, and at 3, 6, and 12 months after your radiation therapy ends, you will fill out a set of questionnaires. The questionnaires will be mostly the same as at your first study visit. This should take about 60-80 minutes. You will also have an ECG at these times.

Questionnaire packets will be mailed to your home by the research staff. After completing the questionnaires, you will return the completed questionnaire packet to the research staff via a pre-paid mailing envelope.

Every day for 7 days in a row, after every time you fill out the questionnaires, you will fill out another sleep diary. During these 7-day periods, you will wear an actigraph watch 24 hours a day to collect the same data as before. Each time, you will mail the actigraph watch back to MD Anderson in postage-paid envelopes that will be provided to you.

If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive mental health screening.

All participants will be asked not to do any other stretching/relaxation practices during the study.

Saliva Testing:

You will provide 4 saliva samples per day for cortisol testing on the following schedule:

- for 3 days before radiation therapy begins

- for 3 days in the last week of radiation therapy

- for 3 days in a row, 3 months after radiation therapy ended

- for 3 days in a row, 6 months after radiation therapy ended

- for 3 days in a row, 12 months after radiation therapy ended

To provide a saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will then mail the samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.

Length of Participation:

Your study participation will be over after you fill out the questionnaires 12 months after radiation therapy. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT01202851
Study type Interventional
Source M.D. Anderson Cancer Center
Status Active, not recruiting
Phase Phase 3
Start date February 10, 2011
Completion date February 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03591848 - Pilote Study of an Online Decision Support Tool for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03095352 - A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Phase 2
Active, not recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer Phase 2
Recruiting NCT03709134 - Genomic Markers for Measuring Metastatic Risk in Breast Cancer Following Primary Treatment
Recruiting NCT03667716 - COM701 in Subjects With Advanced Solid Tumors Phase 1
Recruiting NCT02894398 - Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant Phase 2
Active, not recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Recruiting NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT03432429 - REI-EXCISE iKnife Study N/A
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Recruiting NCT03615573 - Survey Study: Financial Impact of Breast Cancer Treatment
Completed NCT03323333 - Psychosocial Intervention Pilot for Partners in BRCA Testing N/A
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy Phase 1
Withdrawn NCT03285607 - MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT01992432 - Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A