The effectiveness of structured group reminiscence on quality of life, meaning in life and distress tolerance in women survivors of breast cancer
Design
The current research will be a randomized clinical trial using a semi-experimental method with a pre-test-post-test design with a control group.
Settings and conduct
The intervention will be done in the psychology department of Shahid Agah Medical Service Center in Latifi city. The sessions will be held once a week and the subjects will be randomly assigned to the experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1)Informed consent to participate in the intervention; 2)At least 6 months have passed since the end of chemotherapy and radiation therapy; 3)If one has received psychiatric intervention, at least 4 months must have passed, meaning that the medication has exerted its therapeutic effect and we have controlled its effectiveness. Exclusion criteria:1)Absence of more than two sessions; 3)Suffering from an acute psychiatric disorder that requiring hospitalization.
Intervention groups
Intervention group: they will receive group therapy sessions (if receiving medication treatment, 4 months have passed since the treatment). Interventions will last 8 weeks. The sessions will be held once a week and each session will be 60-90 minutes. Control group: they will not receive individual or group psychotherapy, and if they receive medication treatment, 4 months must have passed since drug treatment.
Main outcome variables
The quality of life score in the EORTC QLQ_C30 questionnaire, the meaning in life score in the MLQ questionnaire (2006) and distress tolerance score in the DTS questionnaire (2005)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230617058502N3
Registration date:2024-03-12, 1402/12/22
Registration timing:prospective
Last update:2024-03-12, 1402/12/22
Update count:0
Registration date
2024-03-12, 1402/12/22
Registrant information
Name
Leila Khabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3641 0041
Email address
leila.khabir@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-15, 1403/01/27
Expected recruitment end date
2024-05-16, 1403/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of structured group reminiscence on quality of life, meaning in life and distress tolerance in women survivors of breast cancer
Public title
The effectiveness of structured group reminiscence on quality of life, meaning in life and distress tolerance in women survivors of breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the intervention
Absence of simultaneous participation in other psychotherapy intervention
At least 6 months have passed since the end of chemotherapy and radiation therapy in those who have recovered
If one has received psychiatric intervention, at least 4 months must have passed, meaning that the medication has exerted its therapeutic effect and we have controlled its effectiveness
Exclusion criteria:
Suffering from an acute psychiatric disorder that requiring hospitalization
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
14 numbers from the table of random numbers will be selected by the computer to randomly assign the subjects to the intervention and control groups, which will be named A and B respectively. First, numbers from 1 to 14 will be given to each participant, and then, using a simple random sampling method, 7 people will be randomly selected and placed in the intervention group. The remaining 7 people will also enter 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
Research Ethics Committe of Islamic Azad University-Shiraz Branch
Street address
Faculty of Dentistry, 14th Alley, South Qa'ani street Shiraz
City
Shiraz
Province
Fars
Postal code
00000000
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1402.328
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
The quality of life score in the EORTC QLQ_C30 questionnaire
Timepoint
Assessing the level of quality of life before the intervention and immediatly after the intervention.
Method of measurement
EORTC QIQ_C30 questionnaire
2
Description
The meaning in life score in the MLQ questionnaire of Steger et al. (2006)
Timepoint
Assessing the level of meaning in life before the intervention and immediatly after the intervention.
Method of measurement
MLQ questionnaire Steger et al. (2006)
3
Description
distress tolerance score in the DTS questionnaire of Simons and Gaher (2005)
Timepoint
Assessing the level of distress tolerance before the intervention and immediatly after the intervention.
Method of measurement
DTS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: structured group reminiscing for the intervention group will be done in 8 sessions. The first session includes introduction and familiarity, review of childhood and family life, the second session review of school days, the third session review of the beginning of one's career and working life, going to the open space and having fun, the fourth session of marriage, the fifth session review of memories of home, garden and favorite animals. The sixth session includes reviewing the memories of infancy and childhood of the next generation. In each session, the topic of the next session is determined and the participants are justified to write down everything that comes to their mind about the chosen topic at home and bring it with them. In the next sessions, 10 minutes will be devoted to reviewing assignments.
Category
Rehabilitation
2
Description
Control group: No psychotherapy intervention: the subjects in this group will not receive psychological interventions individually or in groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Musa Al-Reza Health clinic
Full name of responsible person
Dr. Ziba Omidvar
Street address
Islamic Republic Blvd., Moalem St. 1, Ali Bin Musa Al Reza Medical Clinic
City
Larestan
Province
Fars
Postal code
7431477185
Phone
+98 71 5224 4004
Email
info@larums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Leila Khabir
Street address
Shiraz, 5th km of sadra
City
Shiraz
Province
Fars
Postal code
5-71993
Phone
+98 71 3641 0041
Email
info@iaushiraz.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
100
Public or private sector
Private
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
Azar Jafari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Main St., Imam Ali Blvd., 12 Haj Alley
City
Larestan
Province
Fars
Postal code
7431477185
Phone
+98 71 5241 2985
Email
jafariazar78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Leila.Khabir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shiraz, 5 km Sadra city, Shiraz Islamic Azad University
City
Shiraz
Province
Fars
Postal code
7431477185
Phone
+98 61 3641 0041
Email
Leila.Khabir@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azar jafari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Main St., Imam Ali Blvd., 12 Haj Alley
City
Larestan
Province
Fars
Postal code
7431477185
Phone
+98 71 5241 2985
Email
jafariazar78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available