The aim of this study is the effect of midwifery based on counseling support program On body image and sexual satisfaction of breast cancer survivor’s women. This current study is a Controlled clinical trial. Study population are women with breast cancer. Sample size of study are 80 women with breast cancer Who determined in two intervention (n=40) and control (n=40) groups through random allocation. Study inclusion criteria are included: patients who suffer from breast cancer, married women, age group from 30 to 60 years, persons who are using hormone therapy.
Exclusion criteria study are included: Attending in another psychotherapy process, other cancers, participation in educational and consulting sessions and have severe depression according to Beck depression inventory, to conduct complementary medicine interventions. The intervention is included of supportive program which consist of 6 weekly sessions for 90 minutes in intervention and Control group will receive only routine care of Breast cancer treatment.
The questionnaire included: Demographic questionnaire, Beck Depression Inventory, questionnaire body image and sexual satisfaction.
Study outcome is the effect of supportive program on body image and sexual satisfaction of patients with breast cancer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061928528N1
Registration date:2016-07-12, 1395/04/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-12, 1395/04/22
Registrant information
Name
Zeinab Hamzehgardeshi
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.hamzehgardeshi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of midwifery based counseling support program on body image and sexual satisfaction of breast
Public title
Effect of counseling on body image and sexual satisfaction in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria of study are included: patients who suffer from breast cancer, married women, age group from 30 to 60 years, persons who are using hormone therapy, primary and upper education and mastectomy. Exclusion criteria of study are included: attending in another psychotherapy process, other cancers, severe psychiatric disorders ((schizophrenia, bipolar disorder) (based on the individual's history in the patient's records and reports)), patients with using drugs, participation in educational and counselling sessions and having severe depression according to Beck depression inventory, conducting alternative interventions such as complementary, traditional and acupuncture medicine.
Age
From 30 years old to 60 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
Due to educational and supportive nature of the intervention, there is no blinding. In this intervention first 80 people are included based on inclusion criteria and checklist, then 40 persons are assigned in case and 40 persons in control group according to table of random number.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences,Moalem street, Sari.
City
Sari
Postal code
48431-63181
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.MAZUMS.REC.95.2230
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
Body image
Timepoint
Before and after the intervention
Method of measurement
Body image questionnaire scale
2
Description
Sexual satisfaction
Timepoint
Before and after the intervention
Method of measurement
Larson Sexual satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the control group patients only will receive care and treatment related to breast cancer and receive no supportive program.
For to control group educational benefits, after end of supportive sessions for intervention group and completion questionnaires by both groups, an educational program will be administered for patients in control group.
Category
Other
2
Description
Holding the supportive program consist of in 6 weekly sessions for 90 minutes in
Meetings will be presented through lectures, discussions and homework at home.
The first session is include of: 1) Talking about cancer and its effects, treatments and complications, 2) Dealing with stress, 3) Relaxation technique.
Second session is include of: 1) Signs of stress and strategies for coping with stress.
The third session consisted of: 1) Information about breast, 2) Genital organs, 3) Relation to sex and body image.
The fourth session is a bout : 1) Appropriate strategies a bout side effect cancer on sexuality, 2) Changes in appearance, 3) Strategy for effective communication.
The fifth session is include of: 1) Sexual interaction, 2) Sexual response, 3) Strategies for being sexually healthy despite of breast cancer.
The sixth session is include: strategies for sexual satisfaction in sexual relationship. It should be noted that in all of session we will consider time for host, discussions and assessing homework.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Cancer Center
Full name of responsible person
Dr. Zeinab Hamzehgardeshi
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moalem street, Vice chancellor for research, Sari, Mazandaran University of Medical Sciences
City
Sari
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, Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr. Zeinab Hamzehgardeshi
Position
PhD
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3337 8915
Email
z.hamzehgardeshi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr. zeinab hamzehgardeshi
Position
PhD
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3337 8915
Email
z. hamzehgardeshi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Dr.Zeinab Hamzehgardeshi
Position
PhD
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran
City
Sari
Postal code
48431-63181
Phone
+98 11 3336 7342
Fax
+98 11 3337 8915
Email
z.hamzehgardeshi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)