Introduction: Breast cancer is the most common cancer in women. It seems that patients who have contact with a former cancer patient can benefit from meeting someone who had a similar experience. This study evaluated the effect of two kinds of intervention (peer support and educational program) on quality of life in breast cancer patients. Methods: This study is a controlled clinical trial on women diagnosed with breast cancer of stage II or III. The patients took part in peer support group as experimental group or educational group as control group during 3 months and in 6 sessions. The studied sample consisted of 68 patients with breast cancer selected through convenience sampling method considering inclusion and exclusion criteria. Inclusion criteria included women with breast cancer with 20 to 65 years of age who have had mastectomy 6 months to 2 years before and at the time of study were receiving therapy. Patients should have been in stage II or III of non-metastatic breast cancer, who had no chronic disabling underlying condition. Exclusion criteria were patients who would discontinue voluntarily, patients developing any mental or physical disease which would prevent them from continuing the study, those who were absent 2 consecutive sessions and those who got aware of the other group and had meanwhile took part in their sessions. The authors administered SF-36 for evaluating the quality of life pre-and post intervention. Also patient’s adherence was assessed by means of a simple checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102055766N1
Registration date:2011-03-19, 1389/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-19, 1389/12/28
Registrant information
Name
Afsaneh Malekpour Tehrani
Name of organization / entity
Community medicine department of Isfaham University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1627 3708
Email address
a_malekpour@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peer groups on life quality and treatment adherence in patients affected by breast cancer
Public title
Effect of peer groups on life quality and treatment adherence in patients affected by breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included women with breast cancer with 20 to 65 years f age who have had mastectomy 6 months to 2 years before and at the time of study were receiving therapy – whether radiotherapy or medical treatment. Patients should have been be in stage II and III of non-metastatic breast cancer, who had no chronic disabling underlying condition (such as major depression or any other condition which would prevent them from participating in sessions). Also the patients should meet the literacy needed to fill in the questionnaires and have never had participated in such supportive programs before. Exclusion criteria were patients who would discontinue voluntarily, patients developing any mental or physical disease which would prevent them from continuing the study, those who were absent 2 consecutive sessions and those who got aware of the other group and had meanwhile took part in their sessions.
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Not 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
Isfahan University of Medical Sciences, Hezarjerib Avenue
City
Isfahan
Postal code
Approval date
2010-07-04, 1389/04/13
Ethics committee reference number
389164
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
quality of life
Timepoint
3 months
Method of measurement
questionnaire
2
Description
treatment adherence
Timepoint
3 months
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The Control group:
Also in the control group the patients participated in 6 educational sessions held on their disease, its treatment and complications and similar subjects. Each educational session lasted about an hour and a half and was presented by the associated specialist.
Category
Other
2
Description
In experimental group, patients were divided into two groups of 17 in order to participate in peer groups. In each group, two of the leaders were in charge of holding and conducting the sessions. The meetings were held twice-monthly (total number of 6 sessions during intervention) and in each session, the patients would have share their experiences from the disease, worries, cons and pros of the disease and their hopes with other members and would take others experiences. In some of the sessions, the project executor also took part in order to ensure the sessions are held in correct manner and that none of control groups would take part in these sessions. Each session lasted between an hour and half to 2 hours. The patients were encouraged to contact each other out of sessions too, and support each other.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Diseases Research Center
Full name of responsible person
Afsaneh Malekpour Tehrani
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr.Taleb Azarm
Street address
Vice chancellor for research of Isfahan University of Medical Sciences, Hezarjerib Avenue
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Afsaneh Malekpour Tehrani
Position
Doctorate/Resident
Other areas of specialty/work
Street address
Community Medicine Department of Isfahan University of Medical Sciences, Hezarjerib Avenue