• Determining the effect of dignity therapy on Demoralization Syndrome in patients undergoing chemotherapy
Design
In this study, participants will be recruited using convenience sampling. Then, using simple randomization with balanced blocks, individuals will be assigned randomly to the groups. For the random assignment, due to the two-group design of the study, the randomization with balanced blocks with a block size of four will be used. In total, 84 participants (42 in each group) will be invited to participate in the study.
Settings and conduct
This will be a randomized, controlled trial, with participants randomly assigned to either the intervention group or the control group. The population for this study will be patients undergoing chemotherapy treatment in Qazvin province hospitals.
Participants/Inclusion and exclusion criteria
1. Willingness to participate in the research and complete the consent form 2. Full consciousness and the ability to communicate 3. People over 18 years old 4. Being literate in reading and writing in the Persian language 5. Starting chemotherapy at least 6 months ago 6. Access to a phone or mobile for follow-up
Intervention groups
Dignity therapy is a short-term, individual therapy in which the therapist asks a series of open-ended questions to the patient in a 30 to 60-minute session, encouraging the patient to talk about their life and significant events. The patient's speech is recorded, rewritten, and edited. After a few days, it is returned to the patient to allow the creation of necessary changes before the final version is prepared. The final version is kept as a booklet as a memento for the patient's loved ones and family members.
Main outcome variables
Improvement of Demoralization Syndrome in patients treated with chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240725062542N1
Registration date:2024-11-28, 1403/09/08
Registration timing:registered_while_recruiting
Last update:2024-11-28, 1403/09/08
Update count:1
Registration date
2024-11-28, 1403/09/08
Registrant information
Name
Sima Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
nurse.simakazemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Dignity Therapy on the Demoralization in Patients Undergoing Chemotherapy
Public title
The Effect of Dignity Therapy on the Demoralization in Patients Undergoing Chemotherapy in Qazvin City, 2024
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Willingness to participate in the research and complete the consent form 2. Full consciousness and the ability to communicate 3. People over 18 years old 4. Being literate in reading and writing in the Persian language 5. Starting chemotherapy at least 6 months ago 6. Access to a phone or mobile for follow-up
Exclusion criteria:
1. Diagnosis of a psychiatric disorder and use of psychotropic drugs (as diagnosed by a physician) 2. Experience of spiritual crises in the last 6 months (self-report) 3. Use of alcohol and drugs (self-report)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
1. Participants will be selected based on inclusion criteria and availability through a convenience sampling method.
2. After selection, they will be assigned to either group using a simple randomization with balanced blocks.
3. Given the study's two-group nature, a balanced block randomization with a block size of 4 will be employed for the randomization.
4. To determine the randomization order by a block of 4, an online tool for producing random allocation lists (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used.
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 Qazvin University of Medical Sciences
Street address
Qazvin/ Qazvin University of Medical Sciences/ Faculty of Nursing-Midwifery
City
قزوين
Province
Qazvin
Postal code
59811-34197
Approval date
2024-10-22, 1403/08/01
Ethics committee reference number
IR.QUMS.REC.1403.275
Health conditions studied
1
Description of health condition studied
Cancer, Chemotherapy
ICD-10 code
Z51.2
ICD-10 code description
Maintenance chemotherapy NOS
Primary outcomes
1
Description
This is a score that each participant will receive based on the 24-item Distress Thermometer scale developed by Kissane (2004).
Timepoint
The Demoralization Syndrome questionnaire will be administered at three different time points: before the intervention, immediately after the intervention, and three months post-intervention for follow-up.
Method of measurement
The Demoralization Syndrome (DS) is a tool designed by Kissane and colleagues (2004) to assess Demoralization Syndrome in cancer patients.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Dignity therapy is a brief individual therapy in which the therapist asks a series of open-ended questions to the patient within a 30 to 60-minute session, encouraging them to talk about their life and significant events. The patient's speech is recorded, rewritten, and edited. After a few days, it is returned to the patient to allow the creation of necessary changes before the final version is prepared. The final version is kept as a booklet as a memento for the patient's family and loved ones.
Category
Behavior
2
Description
Control Group: In the control group, questionnaires are completed initially, immediately after the intervention, and 3 months post-intervention. At the end, a booklet containing educational points on the disease and points that should be observed during the disease is given to the patient.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran/ Qazvin/ Velayat Hospital
Full name of responsible person
Sima Kazemi
Street address
Bahonar Boulevard/ Qazvin University of Medical Sciences/ Faculty of Nursing-Midwifery
City
قزوين
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
nurse.simakazemi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
دکتر سیدمهدی میرهاشمی
Street address
Bahonar Blvd/ Qazvin University of Medical Sciences/ Research and Technology Vice-Chancellor
City
قزوين
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Sima Kazemi
Position
Faculty Member of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
nurse.simakazemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Ali Soleimani
Position
Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
soleimany.msn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sima Kazemi
Position
Faculty Member of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3333 6001
Email
nurse.simakazemi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data collected will potentially be shareable after the participants have been de-identified.
When the data will become available and for how long
The data will be available 6 months after the study results have been published.
To whom data/document is available
The data will only be accessible to researchers affiliated with academic and research institutions.
Under which criteria data/document could be used
The results of this study may be used by researchers for future studies, provided that they obtain permission from the project coordinators.
From where data/document is obtainable
Executors of the plan: Sima Kazemi (nurse.simakazemi@gmail.com)
Mohammad Ali Soleimani (soleimany.msn@gmail.com)
What processes are involved for a request to access data/document
Please contact us via email for further communication.