An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer

Malignant Neoplasm of Breast Clinical Trial

Official title: An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer: A Randomized Pilot Study

Status Active, not recruiting

Clinical Trial Summary

The goal of this research study is to learn if starting a stress-reduction program before treatment can affect your stress, mood, and physical symptoms during and after treatment for cancer.

This is an investigational study.

Up to 140 participants will be enrolled in this study. All participants will be recruited at MD Anderson.

Clinical Trial Description

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group:

• If you are in Group 1, you will be asked to do daily mind-body exercises for 14 days, beginning before you start receiving chemotherapy. The exercises are short, about 10 minutes per day. The exercises are presented on an online application ("app") that runs on your personal electronic device (such as a mobile phone or tablet). You will be required to install the application on your personal device and to create an account. The study staff will tell you how to perform the exercises, install the application, and create an account. During the 14 days, you will receive automated daily reminders to do the exercises. After you have finished the 14 days of mind-body exercises, you may continue to use the application free of charge for the remainder of the year. After the first year, if you want to keep using the application, you will have to pay for it.

• If you are in Group 2, you will not perform the mind-body exercises. You will be offered one year of free access to the application described above at your last study visit.

Study Visits - All Participants:

Before you start chemotherapy:

• You will complete 10 questionnaires about your stress, mood, physical symptoms, and personality. It should take about 45 minutes to complete all of the questionnaires. You can decide to complete some of the questionnaires from home on a personal computer.

• Information about you (such as age and race) and the disease will be collected from your medical record.

• Blood (about 1 tablespoon) will be drawn for testing of genes and biomarkers that may be related to physical symptoms and mood. Biomarkers are found in the blood and tissue and may help researchers measure the effects of the daily mind-body exercises.

• A hair sample will be taken to measure hormones that are commonly released during times of stress. A lock of hair about the width of a pencil lead will be cut close to your scalp.

• You may be asked to complete a computer task in which you press buttons multiple times in a set time limit. You will receive written instructions on how to complete the task. It should take 15 minutes to complete this task.

At about 15 days after you started the study:

°You will complete one question about your stress. You can complete this question in the clinic or from home on a personal computer.

During chemotherapy:

At about the third month and the sixth month of chemotherapy:

• You will complete 6 questionnaires about your stress, mood, and physical symptoms. It should take about 30 minutes to complete the questionnaires. You can decide to complete these questionnaires from home on a personal computer.

• If your schedule allows for it and you agree, blood (about 1 tablespoon) will be drawn for biomarker testing. If you do not have time to complete this blood draw, it will not affect your participation in this study.

About 6 months after you finish receiving chemotherapy:

• You will complete 8 questionnaires about your stress, mood, and physical symptoms. It should take about 30 minutes to complete the questionnaires.

• Blood (about 1 tablespoon) will be drawn for biomarker testing.

• You may be asked to complete the computer task described above.

Length of Study:

Your participation on this study will be over about 6 months after your last cycle of chemotherapy. If chemotherapy will not be the first treatment you receive for your diagnosis, then your participation on this study will be over at 2 weeks after the start of the study. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Neoplasm of Breast
• Neoplasms

• NCT number: NCT03429907
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2017
• Completion date: April 30, 2026