Protocol summary

Study aim
Determining the Effectiveness of Emotion-Focused Couples Therapy on Marital Intimacy and Molecular Indices in Families of Women diagnosed with Breast Cancer
Design
A randomized controlled clinical trial with parallel groups
Settings and conduct
30 couples who were diagnosed with breast cancer and randomly divided into experimental and control groups (15 couples each). Sample selection for this study would be to provide eligible patients admitted to the Breast Cancer Research Center of Tehran with brief information about the research plan, its goals, and the method of treatment. The levels of oxytocin and cortisol hormones in the two groups will be measured on the day before and after the intervention. Patients in the experimental group will receive weekly emotion-focused couple therapy sessions along with receiving routine medical care for 6 120-minute sessions weekly. However, patients in the control group will receive only routine medical care during this period. Patients in both groups will respond to the Marriage Intimacy Needs Questionnaire (2001) both at baseline and immediately after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married female participants. Participants were sexually active and were less than 55 years of age. Participants had definitive diagnosis of stage two breast cancer. Participants had undergone mastectomy surgery. Minimum literacy. Normal listening ability. Written informed consent to attend therapy sessions. exclusion criteria: mental disorders that require urgent treatment, disruption of the normal course of treatment, lack of cooperation, and severe physical disability and unwillingness to continue to cooperate.
Intervention groups
For first group, emotion-focused couple therapy and for the second group (control), no intervention will be performed.
Main outcome variables
Marital Intimacy; Molecular Indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200207046406N1
Registration date: 2020-03-21, 1399/01/02
Registration timing: retrospective

Last update: 2020-03-21, 1399/01/02
Update count: 0
Registration date
2020-03-21, 1399/01/02
Registrant information
Name
Kobra Hajializadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 6438
Email address
m.hedayati@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-13, 1398/09/22
Expected recruitment end date
2020-03-07, 1398/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Investigation into the Effectiveness of Emotion-Focused Couples Therapy on Marital Intimacy and Molecular Indices in Families of Women diagnosed with Breast Cancer
Public title
An Investigation into the Effectiveness of Emotion-Focused Couples Therapy on Marital Intimacy and Molecular Indices in Families of Women diagnosed with Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants are married women. Participants were sexually active and were less than 55 years of age. Participants had definitive diagnosis of stage two breast cancer. Participants had undergone mastectomy surgery. Minimum literacy. Normal listening ability. Written informed consent to attend therapy sessions.
Exclusion criteria:
Age
To 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: music therapy, cognitive behavioral therapy, and control: First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows: A = music therapy, B = cognitive behavioral therapy, and C control group In this study with three groups A, B and C we create the following six groups and assign 1 to 6 each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the random number table, we choose one of these blocks whenever the numbers 1, 2, 3, 4, 5, 6 appear, and if the other number appears, consider null and go to the next choice. . In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. This way the number of people in the groups will be approximately equal.
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 Hormozgan University of Medical Sciences
Street address
No. 61, 24th Ave., Janbazan Street, South Kurdistan Highway
City
Tehran
Province
Tehran
Postal code
2248795045
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.328

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
D70.1
ICD-10 code description
Agranulocytosis secondary to cancer chemotherapy

Primary outcomes

1

Description
Marital Intimacy
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Bagarouzi Intimacy Needs Questionnaire (2001)

2

Description
Molecular Indices
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Data on dependent variables including cortisol and oxytocin on venous blood samples will be obtained by laboratory assay methods.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group one: Emotion-focused therapy is an emotional understanding that affects the concept of security and vulnerability in relation to the spouse and creates a lasting state of interpersonal relationship chaos. The treatment process will be performed in six sessions based on Bagarouzi (2001) once a week for 90 minutes each session, and generally within a month and a half.
Category
Treatment - Other

2

Description
Control group: No Intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Breast Cancer Research Center
Full name of responsible person
Masoumeh Hedayati
Street address
No. 61, 24th Ave., Janbazan Street, South Kurdistan Highway
City
Tehran
Province
Tehran
Postal code
2246578941
Phone
+98 21 2288 1908
Email
m.hedayati@iaukishint.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Islamic Azad University of Kish International Branch, Free Zone Organization Square, Sana'i Boulevard, Kish Island.
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
Info@Iaukishint.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kobra Hajializadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 139, Taghdiri St., South Jahromi Salimi St., East Ferdows Blvd., Second Square Sadeghiyeh
City
Kish
Province
Hormozgan
Postal code
2246578941
Phone
+98 21 4401 6438
Fax
Email
m.hedayati@iaukishint.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kobra Hajializadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 139, Taghdiri St., South Jahromi Salimi St., East Ferdows Blvd., Second Square Sadeghiyeh
City
Kish
Province
Hormozgan
Postal code
2246578941
Phone
+98 21 4401 6438
Fax
Email
m.hedayati@iaukishint.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kobra Hajializadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 139, Taghdiri St., South Jahromi Salimi St., East Ferdows Blvd., Second Square Sadeghiyeh
City
Kish
Province
Hormozgan
Postal code
2246578941
Phone
+98 21 4401 6438
Fax
Email
m.hedayati@iaukishint.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any type of analysis on the data delivered is permitted
From where data/document is obtainable
Kobra Hajializadeh No. 139, Taghdiri St., South Jahromi Salimi St., East Ferdows Blvd., Second Square Sadeghiyeh Postal code: 2246578941 Tel: +98 21 4401 6438 Email: m.hedayati@iaukishint.ac.ir
What processes are involved for a request to access data/document
The request will be sent by email to: m.hedayati@iaukishint.ac.ir
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