Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508794
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2007-07-27
Brief Title:
Effects of Yoga in Breast Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Biobehavioral Effects of Yoga During Breast Cancer Treatment
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group YG or a stretching ST control group or a waitlist control WL group Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility Measures will be obtained prior to randomization a brief assessment during the middle of radiation therapy during the last week of radiation therapy and 1 3 and 6 months after the last radiation session With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective
Our specific aims in the proposed study are to
Conduct an initial evaluation of whether participation in the yoga program improves patients fatigue and sleep disturbances Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality
Secondary end points will include examining QOL mental health and objective physiological outcomes blood samples for immune measures saliva samples for cortisol levels and heart rate variability
Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing spirituality and finding meaning in the cancer experience
Our specific aims in the proposed study are to
Conduct an initial evaluation of whether participation in the yoga program improves patients fatigue and sleep disturbances Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality
Secondary end points will include examining QOL mental health and objective physiological outcomes blood samples for immune measures saliva samples for cortisol levels and heart rate variability
Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing spirituality and finding meaning in the cancer experience
Detailed Description:
If you choose to take part in this study you will come to M D Anderson for your first visit If this is not convenient a researcher can visit you at your home At this time you will be asked to complete several questionnaires The questions will ask about your sleeping habits how you have been feeling and your general QOL This will take about 45-60 minutes to complete Researchers will then ask you to complete a daily sleep diary for the next 7 days During this time you will be given an actigraph watch to wear that will collect data about your day-time activity and sleeping habits The watch should be worn 24 hours a day for 7 days a week You will have an electrocardiogram ECG - a test to measure the electrical activity of your heart and your breathing rate will be measured
After your first visit to M D Anderson or after a researcher has visited you at home you will be randomly assigned as in the toss of a coin to one of 3 groups
Participants in the first group will take part in a yoga program If you are assigned to the yoga group you will take part in 3 sessions of yoga each week for 6 weeks You may take part in the yoga sessions any 3 days of the week Each yoga session will last around 60 minutes During the yoga sessions you will also be asked to do breathing exercises and to perform different movements and meditation None of the movements are difficult You will be able to follow this program at your own pace
Participants in the second group will take part in a stretching program If you are assigned to the stretching group you will take part in 3 sessions of stretching each week for 6 weeks You may take part in the stretching sessions any 3 days of the week Each stretching session will last around 60 minutes During these stretching sessions you will be asked to do simple stretching exercises None of the movements are difficult You will be able to follow this program at your own pace
Beginning with the second week participants in the first and second groups will be asked to complete a brief questionnaire about the yoga or stretching program before the first class each week The questionnaire will take about 1 to 2 minutes to complete You will also have an ECG and your breathing rate will be measured before and after one of the classes during the third or fourth week and again during the last week Each stretching and yoga session will be audio and video taped for the purpose of quality control
Participants in the third group will not take part in the yoga or stretching program during this study However if you are assigned to this group you will be given the option of participating in the yoga or stretching program after the study has ended This will be after you have finished your last assessment
All participants will complete a brief questionnaire during the middle of radiotherapy The questionnaire will evaluate your treatment-related symptoms and will take about 15 minutes to complete
During the last week of radiotherapy and at 1 3 and 6 months after the end of radiation treatment all participants will be asked to fill out a packet of questionnaires similar to those taken at the first visit It should take about 45 minutes to complete all of the questionnaires If it is not convenient for you to come to M D Anderson a researcher can visit you at home to help with the questionnaires You will then be asked to complete another daily sleep diary for another 7 days During this time you will wear an actigraph watch 24 hours a day for 7 days a week to collect the same data as before During this time you will have an ECG and your breathing rate will be measured
All participants will be asked to refrain from participating in any other yoga classes for the duration of the study
Your participation in this study will be over after your 6-month assessment
This is an investigational study Up to 180 patients will take part in this study All will be enrolled at M D Anderson
After your first visit to M D Anderson or after a researcher has visited you at home you will be randomly assigned as in the toss of a coin to one of 3 groups
Participants in the first group will take part in a yoga program If you are assigned to the yoga group you will take part in 3 sessions of yoga each week for 6 weeks You may take part in the yoga sessions any 3 days of the week Each yoga session will last around 60 minutes During the yoga sessions you will also be asked to do breathing exercises and to perform different movements and meditation None of the movements are difficult You will be able to follow this program at your own pace
Participants in the second group will take part in a stretching program If you are assigned to the stretching group you will take part in 3 sessions of stretching each week for 6 weeks You may take part in the stretching sessions any 3 days of the week Each stretching session will last around 60 minutes During these stretching sessions you will be asked to do simple stretching exercises None of the movements are difficult You will be able to follow this program at your own pace
Beginning with the second week participants in the first and second groups will be asked to complete a brief questionnaire about the yoga or stretching program before the first class each week The questionnaire will take about 1 to 2 minutes to complete You will also have an ECG and your breathing rate will be measured before and after one of the classes during the third or fourth week and again during the last week Each stretching and yoga session will be audio and video taped for the purpose of quality control
Participants in the third group will not take part in the yoga or stretching program during this study However if you are assigned to this group you will be given the option of participating in the yoga or stretching program after the study has ended This will be after you have finished your last assessment
All participants will complete a brief questionnaire during the middle of radiotherapy The questionnaire will evaluate your treatment-related symptoms and will take about 15 minutes to complete
During the last week of radiotherapy and at 1 3 and 6 months after the end of radiation treatment all participants will be asked to fill out a packet of questionnaires similar to those taken at the first visit It should take about 45 minutes to complete all of the questionnaires If it is not convenient for you to come to M D Anderson a researcher can visit you at home to help with the questionnaires You will then be asked to complete another daily sleep diary for another 7 days During this time you will wear an actigraph watch 24 hours a day for 7 days a week to collect the same data as before During this time you will have an ECG and your breathing rate will be measured
All participants will be asked to refrain from participating in any other yoga classes for the duration of the study
Your participation in this study will be over after your 6-month assessment
This is an investigational study Up to 180 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA102385 | OTHER_GRANT | None | None |
| NCI-2010-00743 | REGISTRY | NCI CTRP | None |