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The Effect of family-oriented dignity therapy on depression and spiritual well-being of patients and families of cancer patients.

Protocol summary

Study aim
Determining the effect of family-oriented dignity therapy on depression and spiritual well-being in patients and families of cancer patients.
Design
A clinical trial with a control group, using available sampling method, randomized, block allocation with 4 blocks on 66 patients and family members (33 control group, 33 intervention group)
Settings and conduct
After obtaining consent to conduct the study, demographic, depression and spiritual well-being questionnaires will be provided to the intervention and control groups. The family-centered dignity therapy protocol will be performed on the intervention group during 3 sessions, and after a week, the questionnaires will be provided to the two groups again; During the implementation of the family-centered dignity therapy protocol, common treatments will be provided to the intervention group and the control group; The place of study is selected hospitals of Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
having a medical file with a diagnosis of stage III or IV cancer, 2- being at least 18 years old, 3- hearing and speaking ability to participate in the study, 4- being aware of the disease and being interested in participating in the study, 5- Not having cognitive impairment 6- Have a family caregiver. Also, family caregivers who are at least 18 years old, have sufficient education and are the main caregivers of cancer patients; Deterioration of the patient's condition and unwillingness to participate in the research
Intervention groups
In addition to routine treatments, family-oriented dignity therapy protocol will be implemented on the intervention group and only routine treatments will be implemented on the control group.
Main outcome variables
family-oriented dignity therapy; depression; Spiritual well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240813062741N1
Registration date: 2024-09-05, 1403/06/15
Registration timing: prospective

Last update: 2024-09-05, 1403/06/15
Update count: 0
Registration date
2024-09-05, 1403/06/15
Registrant information
Name
Atefeh Jafarbegloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 8256
Email address
atefehbeglu20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-04-19, 1404/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of family-oriented dignity therapy on depression and spiritual well-being of patients and families of cancer patients.
Public title
The Effect of family-oriented dignity therapy on depression and spiritual well-being of patients and families of cancer patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a medical file with a cancer diagnosis in stage III or IV At least 18 years old Listening and speaking ability to participate in the study Being aware of the disease and being interested in participating in the study Having no cognitive impairment (according to the medical records, no mental illness has been recognized and confirmed by a doctor) Have a family caregiver Family caregivers who are at least 18 years old They have sufficient literacy and are the main caregivers of cancer patients
Exclusion criteria:
The patient's condition worsened Disinclination to continue studying Not consenting to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
The samples of this study will be among the cancer patients who meet the inclusion criteria, referring to selected hospitals affiliated to Tehran University of Medical Sciences, along with active family members as caregivers who meet the inclusion criteria, using available sampling method. became. Then, the sample members will be divided into two control and intervention groups by random block allocation method with blocks of 4. For this purpose, blocks of 4 will be selected, so that the letter A will be assigned to the intervention group and the letter B will be assigned to the control group. Six possible states will be written on separate cards and each card will be assigned a number from one to six, which will be as follows: 1) "AABB" 2) "ABBA" 3) "ABAB" 4) "BBAA" 5) "BAAB" 6) "BABA" Then the numbers will be written on paper and poured into a container, and then a number from one to six will be randomly drawn until the expected number of samples is completed (the number of each number in the envelope in the package will be and the researcher is not aware of the numbers) and every time the numbers are returned to the container. In fact, 15 numbers will be randomly drawn from the container and the sequence of observed numbers will show the sequence of blocks.
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
Nursing and Midwifery Ethics Committee of Tehran University of Medical Sciences
Street address
Nosrat St, Tawheed Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2024-06-09, 1403/03/20
Ethics committee reference number
IR.TUMS.FNM.REC.1403.067

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Depression score in the Beck questionnaire
Timepoint
The effect of family-oriented dignity therapy on depression before the start of the study and 10 days after the intervention
Method of measurement
Beck depression questionnaire to measure depression

2

Description
spiritual well-being score in the Polotzin and Ellison spiritual well-being questionnaire
Timepoint
The effect of family-oriented dignity therapy on spiritual well-being before the start of the study and 10 days after the intervention
Method of measurement
Polotzin and Ellison spiritual well-being questionnaire to measure spiritual well-being

Secondary outcomes

1

Description
Age
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

2

Description
Sex
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

3

Description
Marital
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

4

Description
Employment status
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

5

Description
Education
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

6

Description
Type of cancer
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

7

Description
‏Duration of cancer diagnosis
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

8

Description
Family caregivers of cancer patients
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

9

Description
Relative to the patient
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

10

Description
Duration of care
Timepoint
At the beginning of the study and 10 days after the intervention
Method of measurement
Demographic questionnaire

Intervention groups

1

Description
Intervention group: 3 demographic questionnaires, Beck depression questionnaire and spiritual well-being questionnaire will be used for this study; Before the intervention, the questionnaires will be given to the intervention and control groups, and after completing the questionnaires, the family-oriented dignity therapy protocol will be implemented in the intervention group. In order to carry out the dignity therapy method, three sessions of 30-60 minutes will be considered for 3 weeks. In the first session, the researcher, while introducing the goals of the research, familiarized the participant with the questions of the family-oriented dignity therapy protocol and provided the necessary opportunity to think about their statements in the next interview session. In the second session, which is 2 to 3 days after The basic meeting will be held, the researcher will guide the client during the interview with the patient-family couple and using the guiding questions of the family-oriented dignity therapy protocol to talk about the patient's life experiences in the context of the family. The participant's statements will be recorded during the interview while obtaining his permission. Then the recorded interviews are transcribed and edited (the questions are focused on eliciting the patients' life experiences in relation to their families, while the caregivers' answers are used to enrich the patients' narratives). In the third session, which is usually held 3 days after the third session, the therapist invites the patient and his family and provides them with the final version of the text to share with them. After the family-centered dignity therapy interventions, the questionnaires will be provided to the intervention and control groups again.
Category
Rehabilitation

2

Description
Control group: 3 demographic questionnaires, Beck's depression and spiritual well-being questionnaires will be provided to the patients before the intervention and 10 days after the intervention. At this time, only routine treatments are performed for the intervention group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected hospitals of Tehran University of Medical Sciences
Full name of responsible person
Atefeh jafarbegloo
Street address
Nursing And Midwifery School, Tehran University Of Medical Science, Nosrat St, Tawheed Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central Building of Tehran University of medical sciences, Keshavarz Blvd, intersection of Qods Street, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
…
Phone
+98 21 81631
Email
Tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Atefeh jafarbegloo
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing And Midwifery School, Tehran University Of Medical Science, Nosrat St, Tawheed Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Atefehbeglu20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefeh Jafarbegloo
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing And Midwifery School, Tehran University Of Medical Science, Nosrat St, Tawheed Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Atefehbeglu20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefeh jafarbegloo
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing And Midwifery School, Tehran University Of Medical Science, Nosrat St, Tawheed Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Atefehbeglu20@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be 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
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Non-identifiable data of the participants such as age, gender, education, marital status, type of cancer and its stage, relative to the family caregiver, duration of diagnosis and employment status will be included in the research without giving the names and addresses of the participants. Also, for the clinical study report, the research results will be provided to the researchers.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Access to the data is free for researchers interested in this topic
Under which criteria data/document could be used
In order to use in other researches and to use the data to improve the treatment of cancer patients
From where data/document is obtainable
To access the data, you can use the email: atefehbeglu20@gmail.com or contact number 09100747091
What processes are involved for a request to access data/document
In order to access the data correctly, the applicant can contact the researcher through the email or the contact number that is included in the article, and the data will be available to her within 2 weeks.
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