Determining the Effect of Dialectical Behavior Therapy on the Feeling of Loneliness in Oncology patients
Design
Randomized,Controlled,Single blinded clinical trial on 30 Patients.The block method will be used for random allocation.
Settings and conduct
In this study, UCLA Loneliness Questionnaire will be completed by all the patients who meet the inclusion criteria in the first half of 1402 at the Radiotherapy and Oncology Center of Birjand, and among them 30 people who will get the cut score of UCLA Loneliness Questionnaire will be selected.Before random allocation, the participants are told that dialectical therapy skills will be provided in PDF form or face-to-face training. Dialectical behavioral therapy skills will be taught for the intervention group during 8 sessions at IranMehr Radiotherapy and Oncology Center in Birjand. At the end of the study, the summary of the skills taught in the dialectic behavior therapy sessions will be provided to the control group in PDF format.
Participants/Inclusion and exclusion criteria
The Ability to Communicate
Diagnosis of Cancer by an Oncologist
Completing at least One Course of Radiotherapy or Chemotherapy
The Ability to Read and Write
Living in Birjand
20 to 65 years old
Non-participation in the present research project intervention
Not participating in a research program at the same time
Not suffering from a specific physical or mental illness except cancer
Not taking special medical and psychiatric drugs (except cancer treatment drugs)
Intervention groups
In this study, after random sampling and allocation, dialectical behavior therapy skills will be taught to the intervention group under the supervision of a psychologist in 8 sessions. At the end of the study, the summary of the skills taught in the dialectical behavior therapy sessions will be available for the control group in PDF format.
Main outcome variables
Feeling of Loneliness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060762N1
Registration date:2024-02-11, 1402/11/22
Registration timing:prospective
Last update:2024-02-11, 1402/11/22
Update count:0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Mahdi Mirhoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 5510
Email address
mahdi.mirhoseini99@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Dialectical Behavioral Therapy on Loneliness of Oncology Patients
Public title
The Effect of Dialectical Behavioral Therapy on Loneliness of Oncology Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The Ability to Communicate
Diagnosis of Cancer by an Oncologist
Completing at least One Course of Radiotherapy or Chemotherapy
The Ability to Read and Write
Living in Birjand
20 to 65 years old
Exclusion criteria:
The History of Participating in the Intervention of the Present Research Project
Concurrent Participation in the same Research Program
Suffering from Specific Physical and Mental Illness except Cancer
Not taking special Medical and Psychiatric Drugs (except Drugs for Cancer Treatment)
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The random block method will be as follows:
1)The size of each block will be 6.
2)All possible balanced combinations will be written with 3 control cases and 3 intervention cases. (20 combinations)
3)Blocks are randomly selected to allocate each 30 participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after sampling and before random allocation, participants are told that dialectical behavior therapy skills will be provided in PDF form or face-to-face training.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari Blvd.,Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2024-01-21, 1402/11/01
Ethics committee reference number
IR.BUMS.REC.1402.463
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
2
Description of health condition studied
Cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
3
Description of health condition studied
Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
4
Description of health condition studied
Cancer
ICD-10 code
C94
ICD-10 code description
Other leukemias of specified cell type
5
Description of health condition studied
Cancer
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri
Primary outcomes
1
Description
Feeling of Loneliness
Timepoint
Before Starting the Intervention,After Completing the Intervention and one Month After Completing the Intervention
Method of measurement
UCLA Loneliness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, dialectical behavior therapy skills will be taught face-to-face in 8 sessions for intervention group.
Category
Rehabilitation
2
Description
Control group: After the end of the study, the summary of the skills taught to the intervention group will be provided to the control group in PDF format.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranmehr Radiotherapy and Oncology Center
Full name of responsible person
Dr. Hasan Mortazi
Street address
30 th Ghafari Ave.,Ghafari Blvd.,
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3162 6800
Email
Iranmehr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Masoud Yousefi
Street address
Ghafari Blvd., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
webda@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
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
Birjand University of Medical Sciences
Full name of responsible person
Mahdi Mirhoseini
Position
Psychiatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 251, 30 th West Ebneyamin Ave., Taleghani Blvd.,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617964651
Phone
+98 51 4422 5510
Email
Mahdi.mirhoseini99@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Ahmad Nasiri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghafari Blvd., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
nasiri2006@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahdi Mirhoseini
Position
Psychiatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 251., 30th West Ebneyamin Ave., Taleghani Blvd.,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617964651
Phone
+98 51 4422 5510
Email
Mahdi.mirhoseini99@bums.ac.ir
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
Baesd on Ethical Issues
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available