The aim of this study was to investigate the effect of yoga on quality of life in breast cancer patients undergoing chemotherapy and radiotherapy. The four-group clinical trial was conducted in two stages, before and after the intervention. Population study was women with breast cancer referred to Syedalshohada "AS" hospital in Isfahan. In total, 80 female patients with breast cancer pathologic stage II and III were randomly sampled. Exclusion criteria included relapse, and disease duration was less than 2 weeks. Yoga intervention program was for 75 minutes a day in between, versus the control group was 8 weeks without getting any CAM. The instrument for data collecting included questionnaire demographic; quality of life questionnaire Organization for Research and Treatment of Cancer (Europe EORTC QLQ-C30); and a standard questionnaire specifically to assess quality of life in breast cancer (EORTC QLQ-BR23) which was conducted face to face interviews by a specialist oncology with patients, over three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071513998N1
Registration date:2013-08-07, 1392/05/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-07, 1392/05/16
Registrant information
Name
Faridokht Yazdani
Name of organization / entity
Islamic Azad University, Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 33 1229 1111
Email address
f-yazdani@pnu.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Najafabad branch
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of yoga on the quality of life in breast cancer patients undergoing chemotherapy and radiotherapy
Public title
Roll of yoga to improve the quality of life in breast cancer patients receiving chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1 - having age between 25 to 65 years, 2 - a consciousness, 3 - ability to communicate and interact appropriately in completing the questionnaire, 4 - Pathological diagnosis of breast cancer, 5 - willingness of patients to participate in study, 6 - Stage I and II breast cancer pathology, 7 - no metastasis or lymphatic metastasis zone, 8 - or complete a simple mastectomy, breast conservation surgery (lumpectomy,quadranetomy), 9 - two to six weeks after completion of chemotherapy and or radiation, 10 - Combination therapy: prescribing two or more chemotherapeutic agents for the treatment of cancer (and other performance enhancing drugs have a synergistic effect). 11 - External beam radiation (teletherapy): The patient has been exposed to radiation producing devices, 12 - not use other methods of complementary medicine at the time of the study, 13 - more than 2,500 white blood cells per cubic millimeter, 14 - Count platelets more than 50,000 per cubic millimeter, 15 - temperature less than 38.3 ° C or 101 ° F, 16 - no signs of infection and bleeding. Exclusion criteria for recurrence, disease duration less than 2 weeks, disorder comorbidity with other mental disorders, a history of cancer, previous surgery on the breast.
Age
From 25 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Research Department, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2011-12-31, 1390/10/10
Ethics committee reference number
290211
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
2013 ICD-1
ICD-10 code description
•A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003
Primary outcomes
1
Description
quality of life
Timepoint
8 weeks after intervention
Method of measurement
questionnaire Organization for Research and Treatment of Cancer Europe EORTC QLQ-C30)); and a standard questionnaire specifically to assess quality of life in breast cancer (EORTC QLQ-BR23);
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Yoga sessions will run for 8 weeks 75 minute every couple of days. Technique was the yoga asana. The importance of education given stretching muscles, tendons and ligaments joint, muscle contraction on timely in whole body, reverse movements, torsion and bending modes, status of balance, breathing and relaxation techniques. Insufficient attention was being for every company that she was able to perform the exercises for health. To ensure of doing yoga by cancer patients undergoing chemotherapy and radiotherapy, gave them home exercise checklist and asked them to do exercise at least twice a day and mark on checklist. At the start of the next session, after receiving the checklist, the instructional content review and were answered to individual questions. 8 weeks after the intervention, the experimental group patients' quality of life was measured again.
Category
Lifestyle
2
Description
Control group: The control group patients were asked during the investigation 8 weeks; do not use a variety of complementary and alternative therapies such as yoga. During this period, the researcher only to be followed them by a call from (once every two weeks). After 8 weeks, once again invited the control group, and were given questionnaires to complete it. After the last of gathering data, the educational pamphlet in yoga was given to control group, and clients to use yoga and other programs were referred to Omid Mehr Community depended to Center of Prognosis and Treatment of Breast Disease in Syedolshohada (AS) hospital.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Syedolshohada (AS) Hospital
Full name of responsible person
Faridokht Yazdani
Street address
Isfahan University of Medical Science
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Najafabad branch
Full name of responsible person
Research Assistant
Street address
Research Department, Najafabad branch
City
Najafabad
Grant name
طرح های پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Najafabad branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Najafabad Branch
Full name of responsible person
Faridokht Yazdani
Position
MSc - faculty
Other areas of specialty/work
Street address
Nursing and Midwifery School, Najafabad Branch, Islamic Azad University,Isfahan,Iran