This study is a randomized clinical trial on 69 women with breast cancer, nominated for breast surgery referred to cancer institute of Emam Khomeini Hospital . After signing informed consent, eligible patients were assigned to intervention and control groups. In intervention group, discharge planning begins on the client’s admission and continued to 6 weeks after discharge of hospital. The intervention protocol consisted of preoperative teaching, Postoperative follow up, two client visits and 6 phone calls during the 6 weeks immediately following discharge. The two client visits occurred within first and sixth weeks of the returning women to home after surgery. In the control group hospital’s routine program implemented. Quality of life was measured using combination of two questionnaires SF 36 and breast cancer Quality of life questionnaire. Data were collected at two times over the course of the study (at recruitment and 6 weeks after surgery).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101105580N1
Registration date:2011-05-31, 1390/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-31, 1390/03/10
Registrant information
Name
Somaieh Salmany
Name of organization / entity
Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8474 1129
Email address
nikbakht@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-11-07, 1389/08/16
Expected recruitment end date
2011-03-16, 1389/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the Effectiveness of Implementation Discharge Planning Program on Quality of Life among Breast Cancer Patients
Public title
Effectiveness of Implementation Discharge Planning Program on Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1.Verifiable diagnosis of breast cancer by oncologist 2. All samples nominated for surgery of breast cancer first time 3.Not having any history of another malignancy 4. Not having any psychological problem verified by psychologist 5. without any other chronic and systemic diseases.
Exclusion criteria: 1. Having reconstruction surgery during the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
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
Vice chancellor for research, Tehran university of medical sciences
Street address
Keshavarz blvd
City
Tehran
Postal code
Approval date
2010-08-07, 1389/05/16
Ethics committee reference number
624/130/ص/89
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
Before surgery and 6 weeks after surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Discharge planning consist of preoperative teaching, Postoperative follow up, clients visit, Telephone counseling. The focus of this program was clients education and Training program based on the client’s real needs. Teaching method was done as face to face approach. The period of teaching was 30-40 min based on client’s teaching needs.
Category
Prevention
2
Description
Contol group: hospital’s routine program was implemented included some teaching pamphlet.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute, Emam Khomeini hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz blvd
City
Tehran
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, Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Somaie Salmani
Position
Master of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq., Post Code:00981419733171
City
Tehran
Postal code
Phone
+98 21 8896 5034
Fax
Email
s.salmany5510@gmail.com , s.paris41@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Alireza Nikbakht Nasrabadi
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq.
City
Tehran
Postal code
Phone
+98 912 205 5362
Fax
+98 21 6642 7255
Email
nikbakht@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Somaie Salmani
Position
Master of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat St., Tohid Sq.
City
Tehran
Postal code
00981419733171
Phone
+98 21 8896 5034
Fax
Email
s.salmany5510@gmail.com , s.paris41@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)