(1) Objectives: Effects of husband’s education on meting supportive care needs of breast cancer patients.
(2) Design: This study is a randomized clinical trial with two groups (intervention and control). Because of lack of similar studies, the sample size will be measure by pilot studies. The participants will collect with inclusion and exclusion criteria and assign randomly to experimental and control groups.
(3) Setting and conduct: Three session educational intervention in 2 hours for 3 week with group discussion, question and answer will conduct in East Azerbaijan breast cancer supportive association.
(4) Participants including major eligibility criteria: Partner’s breast cancer will be introduced in patients training sessions who their wife have Inclusion and Exclusion criteria.
(5) Intervention: These interventions designed for partners and it’s about patients needs and based by the questions in scale. Three session educational intervention in 2 hours for 3 week will conduct. Before and one month after the last training session, the supportive care needs survey questionnaire (SCNS) will be completed by the all patients (intervention and control group).
(6) Main outcome measures variables: Supportive care needs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012512264N1
Registration date:2013-08-04, 1392/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Farahnaz Abdollahzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 0648
Email address
abdollahzadehf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences (seyed kazem shakori)
Expected recruitment start date
2013-02-04, 1391/11/16
Expected recruitment end date
2013-04-18, 1392/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of husbands education on meting supportive care needs of breast cancer patients in Tabriz 2013: A clinical trial
Public title
Effects of husbands education on meting supportive care needs of breast cancer patients in Tabriz 2013: A clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: Diagnosis of breast cancer; Awareness of breast cancer; Have at least 18 years; Married and living with partner.
Exclusion criteria: Don’t completed the questionnaires at each stage of the study; Don’t participate in training session; Separation or died partner during the study; Recurrence or metastasis during the study.
Age
From 13 years old to 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
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
1
Registry name
Not
Secondary trial Id
Not
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences; Golgasht Avenue.
City
Tabriz
Postal code
Approval date
2013-01-21, 1391/11/02
Ethics committee reference number
91192
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
Z55.8
ICD-10 code description
Other problems related to education and literacy
Primary outcomes
1
Description
Supportive Care Needs
Timepoint
Before and one month after intervention
Method of measurement
Supportive Care Needs Survey (SCNS)
Secondary outcomes
1
Description
Husband's breast cancer psychoeducation
Timepoint
before and one month after intervention
Method of measurement
Supportive care needs survey
Intervention groups
1
Description
Three sessions weekly educational intervention will be conducted in 2 hours, in the breast cancer supportive association. First session present by oncologist and one nurse and it’s about physical needs that including pain, lack of energy, nausea, vomiting, sleeping well. second session present by psychologist and one nurse and it’s about psychological needs e.g. anxiety and depression, distress, various concerns in aspects of cancer, fear of spread cancer in body, fear of death, sexual problems and emotional issues and factors effect on breast cancer. Third session it’s about aspects of social, economic and this impact in during illness and discus accessing to health care and counseling with summary of information.
Category
Other
2
Description
In control group, their husband doesn’t receive any interventions. But at the end of this study they will receive booklet about information .and breast cancer patient just filling the questionnaire.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Cancer Supportive Association
Full name of responsible person
Mis.Vatandoost
Street address
Zargham Complex, Pastoor Avenue.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research Deputy in Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Shakouri
Street address
Tabriz University of Medical Sciences, Golgasht Avenue.
City
Tabriz
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 Deputy in Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Narges Moradi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue.
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
Nargesmoradi68@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Farahnaz Abdollahzadeh
Position
Master of Science in nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Shariati Avenue.
City
Tabriz
Postal code
Phone
+98 41 1477 0648
Fax
Email
Abdollahzadehf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Narges Moradi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Kosar Dormitory, Shariati Avenue.
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
Email
Nargesmoradi68@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)