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The effectiveness of acceptance and commitment group therapy on body image, sexual self-schema and marital intimacy in women with uterine cancer and breast lumpectomy surgery

Protocol summary

Study aim
To investigate the effectiveness of acceptance and commitment group therapy on body image, sexual self-schema and marital intimacy in women with uterine cancer and breast lumpectomy surgery
Design
This clinical trial with control group, with parallel groups, randomized and without blinding will be performed on 30 women with uterine cancer and breast lumpectomy surgery. Random allocation software is used for randomization
Settings and conduct
In this study, which will be performed at reza radiotherapy and oncology center, a psychological method will be performed in woman patients with uterine cancer and breast lumpectomy surgery. Before and after the intervention, individuals will answer the relevant questionnaires. There will be no blinding in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 21 to 51 years, Having at least a high school diploma, Willingness to participate in the study, Not receiving psychological treatment since diagnosis, Having uterine cancer, Having breast lumpectomy surgery Exclusion criteria: having advanced or metastatic breast cancer, Unwillingness or inability to participate in group psychotherapy sessions, Having other medical and psychiatric disorders
Intervention groups
Intervention group: Acceptance and commitment therapy (ACT) is one of the third wave therapies and its main purpose is to focus on the psychological connection of the person with his thoughts and feelings. Women with uterine cancer and breast lumpectomy surgery will undergo ACT intervention during 8 sessions of 90 minutes (two sessions per week) for 1 months. control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this group
Main outcome variables
body image concern, women's Sexual Self-Schema, marital intimacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200117046165N1
Registration date: 2020-08-16, 1399/05/26
Registration timing: retrospective

Last update: 2020-08-16, 1399/05/26
Update count: 0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Narges Zarei
Name of organization / entity
The University of Allameh Tabatabaei
Country
Iran (Islamic Republic of)
Phone
+98 51 3726 1836
Email address
nargeszarei57@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment group therapy on body image, sexual self-schema and marital intimacy in women with uterine cancer and breast lumpectomy surgery
Public title
The effect of acceptance and commitment group therapy on body image, sexual self-schema and marital intimacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 21 to 51 years Having at least a high school diploma Willingness to participate in the study Not receiving psychological treatment since diagnosis Having uterine cancer Having breast lumpectomy surgery
Exclusion criteria:
Having advanced or metastatic breast cancer Unwillingness or inability to participate in group psychotherapy sessions Having other medical and psychiatric disorders
Age
From 21 years old to 51 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be based on a simple random method. Therefore, a random number is assigned to each patient by the table of random numbers, according to which if the number is odd, the patient will be in the intervention group, and if it is an even number, the patient will be in the control group
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 Hakim Sabzevari University
Street address
Hakim Sabzevari University Campus, Tovhid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.HSU.REC.1398.026

Health conditions studied

1

Description of health condition studied
Uterine cancer
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri

Primary outcomes

1

Description
Body Image Concern
Timepoint
Before the intervention, 30 days after the intervention
Method of measurement
The Littelton Body Image Concern Inventory (2005)

2

Description
women's Sexual Self-Schema
Timepoint
Before the intervention, 30 days after the intervention
Method of measurement
The Cyranowski women's Sexual Self-Schema Scale (1994)

3

Description
Marital Intimacy
Timepoint
Before the intervention, 30 days after the intervention
Method of measurement
The Bertommen Marital Intimacy Questionnaire (1995)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Women with uterine cancer and breast lumpectomy surgery will undergo acceptance and commitment group therapy intervention during 8 sessions of 90 minutes (two sessions per week) for 1 months which is based on the acceptance and commitment therapy book of Hayes (1999). The summary of the content of each session is as follows: 1) Introduction and general description of therapeutic approach and explaining the rules and expectations; 2) Assessing patient problems; 3) Elimination of inefficient control of negative events; 4) Separating assessments from personal experiences and observing thoughts without judgment; 5) Contact now and considered self as a context and teaching techniques of mindfulness; 6) Extracting value of patients’ life and evaluation on the basis of their importance; 7) Providing practical solutions to overcome barriers and planning for commitment to pursue the great values of life; 8) A brief description of concepts discussed in each session
Category
Treatment - Other

2

Description
Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Reza Radiotherapy and Oncology Center
Full name of responsible person
Samira Keramati
Street address
Reza Radiotherapy and Oncology Center, 19 Rafsanjani St., Haftom Azar Sq., Rafsanjani Hwy., International Fair Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9186116616
Phone
+98 51 3500 8715
Fax
+98 51 3522 5671
Email
info@rroc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Ahmed Farzaneh Kord
Street address
Hakim Sabzevari University Campus, Tovhid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617666666
Phone
+98 51 4441 9050
Fax
+98 51 4441 4244
Email
farzaneh@hsu.ac.ir
Web page address
http://www.hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hakim Sabzevari University
Proportion provided by this source
100
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
Bojnourd University
Full name of responsible person
Samira Keramati
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 4, Block 8, Pardis residential complex, 2nd Rasti, 26th Adib, Madar Sq., Qasem Abad
City
Mashhad
Province
Razavi Khorasan
Postal code
9186116616
Phone
+98 51 3621 6117
Email
samira88keramati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shareh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hakim Sabzevari University Campus, Tovhid Town
City
Mashsad
Province
Razavi Khorasan
Postal code
9617666666
Phone
+98 51 4441 9050
Fax
+98 51 4441 4244
Email
hsharreh@yahoo.com.au
Web page address
http://www.hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabatabayi University Tehran
Full name of responsible person
Narges Zarei
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 86, 13th Valiasr Alley, Valiasr Blv
City
Mashsad
Province
Razavi Khorasan
Postal code
9196745169
Phone
+0513 763 9511
Email
nargeszarei57@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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