Determine the effect of a home-based exercise on quality of life in breast cancer patients
Design
In this study, 84 breast cancer patients will randomly allocated into control or exercise group. Exercise group will get under a 3-month exercise group. Quality of life will be assessed before and three months after the intervention.
Settings and conduct
This study will be done in the Breast Diseases Clinic in Motamed Cancer institute. Blinding is not a feasible approach in that study.
Participants/Inclusion and exclusion criteria
Breast cancer patients who have less than 55 years of age and in the stage I or II will be included in the study. Patients who have regular exercise or disabling diseases will be excluded
Intervention groups
َ A home-based exercise for 3 months
Main outcome variables
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140810018746N1
Registration date:2018-01-08, 1396/10/18
Registration timing:registered_while_recruiting
Last update:2018-01-08, 1396/10/18
Update count:0
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 82880
Email address
nasim.khosravi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of Effects of Home Based Exercise on the Quality of Life of Breast Cancer Survivors in Clinical Trial
Public title
Home-based exercise and quality of life in breast cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
breast cancer
stage I and II
Age between 18-55 years
Exclusion criteria:
Having regular physical activity
Having disease which prevent them to engage in exercise
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization with size of 4 was used. participants in each block were randomly assigned into exercise or control group by flipping the coin. Concealed allocation was not considered .
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
Ethics committee of Breast Cancer Research Center
Street address
No 146, Gandi st, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1517964311
Approval date
2015-10-11, 1394/07/19
Ethics committee reference number
IR.ACECR.IBCRC.REC.1394.11
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.919
ICD-10 code description
Malignant neoplasm of unspecified site of unspecified female breast
Primary outcomes
1
Description
quality of life
Timepoint
Before and after intervention
Method of measurement
EORTC-QLQ and EORTC-BR23 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Home-based exercise. An intervention combined of walking, stretch and balance exercise which will be done within 3 months.