Relaxation for Women With Breast Cancer Undergoing Radiotherapy (NCT01202851) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Relaxation for Women With Breast Cancer Undergoing Radiotherapy
United States681 participantsStarted 2011-02-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Women with stage 0 - III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only).
. 18 years of age or older (patient and spouse/partner).
. Able to read, write, and speak English or Spanish (patient and spouse/partner).
Exclusion criteria
. Patients who have any major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder).
. Patients who have not undergone any surgical treatment for their cancer.
. Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial testing a relaxation program for women with breast cancer going through radiotherapy — how does a relaxation-focused study like this fit alongside my actual cancer treatment, and would participating in any way change or delay my radiotherapy plan?
2Since the trial is active but no longer enrolling new participants, is there any chance I could still be considered for it, or are there similar relaxation or stress-reduction programs already available to me through this hospital or cancer center?
3The trial is specifically measuring how effective the relaxation program is — what kinds of outcomes are they tracking, like anxiety, sleep, pain, or quality of life, and how might those relate to challenges I'm likely to face during my own radiotherapy?
4Radiotherapy can be a stressful and tiring process — based on what's already known from this or similar studies, would you recommend I pursue a structured relaxation program as part of my care, and if so, what options do we have right now?
5Are there any types of patients in this trial I should know about — for example, are there specific stages of breast cancer or treatment schedules involved — that might help us figure out whether the findings would be relevant to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of Relaxation Program
Timeframe: Prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy
. Patients who have practiced yoga or taken yoga classes in the year prior to study enrollment or who are currently engaged in a regular mind-body practice.