Determine the effect of Dignity therapy on quality of life and hope in patients with cancer
Design
This is a two-group experimental research with pre test – post test design. 78 patients with cancer were involved in the study after obtaining informed consent. They were randomly assigned in two groups; 36 patients as the intervention group and 36 patients assumed to be the control group.
Settings and conduct
dignity therapy was performed in the Iran Mehr Center in patients with cancer. This therapy is an individual psychotherapy interview.
Participants/Inclusion and exclusion criteria
Cancer patients older than 18 years living in Birjand who are aware of their illness and have no history of taking psychotropic drugs are included in the study.Patients who have not reached the admission stage of the disease are also excluded from the study.
Intervention groups
dignity therapy group:dignity therapy is done
Control group: dignity therapy is not done
Main outcome variables
quality of life؛hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190604043820N1
Registration date:2019-10-13, 1398/07/21
Registration timing:retrospective
Last update:2019-10-13, 1398/07/21
Update count:0
Registration date
2019-10-13, 1398/07/21
Registrant information
Name
Zahra Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3723 7846
Email address
zahra.karimi3404@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-05-31, 1398/03/10
Trial completion date
2019-05-31, 1398/03/10
Scientific title
The effect of Dignity therapy on quality of life and hope in patients with cancer
Public title
The effect of Dignity therapy in patients with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in the research and complete the informed consent form
be aware of their disease
At least 6 months have passed since diagnosis
be aged 18 years or older
having the ability to reading and writing (in order to answer the questionnaire)
having physical ability without cognitive impairment (according to Mini Mental Status Examination Score) to attending in the interviews and responding to the questionnaire
not having major psychiatric disorders(such as Schizophrenia and major depression) and not using effective psychiatric drugs
not travelling more than 4 weeks and not immigrating from Birjand to other cities during the next one month
Exclusion criteria:
Patients who are still in the process of denying the disease and have not accepted it
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
The names of the eligible patients will be written on the sheets and put in a box and removed by individual names into two groups of control and intervention.
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 Birjand University of Medical Sciences
Street address
Ayatollah Ghaffari Avenue, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2019-01-13, 1397/10/23
Ethics committee reference number
IR.BUMS.REC.1397.267
Health conditions studied
1
Description of health condition studied
patients with cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
quality of life
Timepoint
Immediately before intervention and one month after intervention
Method of measurement
Quality of Life Questionnaire-Core 30(QLQ-C30)
2
Description
hope
Timepoint
Immediately before intervention and one month after intervention
Method of measurement
Herth Hope Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During an interview for 30 to 45 minutes, the therapist will give the patient the opportunity to recall aspects of life such as when he feels proud or issues that are meaningful to him and is part of the history of life he likes. Then, during the two 30- to 45-minute sessions, the patient's statements will be recorded, transcribed, and edited, and if confirmed, the patient will be returned to him in a document producing the patient to share it with those who would like to.
Category
Treatment - Other
2
Description
Control group: Received routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
IranMehr radiotherapy and oncology center
Full name of responsible person
Doctor Ahmad Reza Sebzari
Street address
Ayatollah Ghaffari Avenue,IranMehr radiotherapy and oncology center
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۴۴۴۷۱
Phone
+98 56 3162 6800
Email
zahra.karimi3404@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Doctor Tooba Kazemi
Street address
Ayatollah Ghaffari Avenue, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
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
Doctor Ahmad Nasiri Forag
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghaffari Avenue, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1406
Email
Zahra.karimi3404@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Doctor Ahmad Nasiri Forag
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghaffari Avenue, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1406
Email
zahra.karimi3404@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Doctor Ahmad Nasiri Forag
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghaffari Avenue, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1406
Email
zahra.karimi3404@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
No more information
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
Undecided - It is not yet known if there will be 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