1. Home
  2. Approved trials
  3. » فارسی

The Effect of Dignity Therapy on the Demoralization in Patients Undergoing Chemotherapy

 View older revisions Content changed at 2025-09-16, 1404/06/25

Protocol summary

Study aim
• 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
The clinical trial has been completed and we are ready to update the information on IRCT.
Acronym
IRCT registration information
IRCT registration number: IRCT20240725062542N1
Registration date: 2024-11-28, 1403/09/08
Registration timing: prospective

Last update: 2025-09-16, 1404/06/25
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
2024-12-31, 1403/10/11
Expected recruitment end date
2025-04-28, 1404/02/08
Actual recruitment start date
2024-12-31, 1403/10/11
Actual recruitment end date
2025-04-28, 1404/02/08
Trial completion date
2025-04-28, 1404/02/08
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
Actual sample size reached: 79
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
Other
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
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
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
Velayat Hospital, Minodar, Qazvin, Iran
Full name of responsible person
Sima Kazemi
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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mirhashmi
Street address
Deputy of Research and Technology, Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin, Iran
City
Qazvin
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.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2025-09-16, 1404/06/25
Table of baseline comparison
Variable Intervention (N=42) Control (N=42) Between-group comparison t(p)/χ²(p)
Age (year) 53.69 (13.35) 51.57 (12.86) 0.74 (0.46)
Cancer duration (month) 29.79 (40.65) 24.79 (17.70) 0.73 (0.47)
Chemotherapy duration (month) 11.64 (11.53) 13.12 (9.07) -0.65 (0.52)
Perceived social support (0–10 scale) 7.43 (2.49) 7.88 (1.86) -0.94 (0.35)
Perceived religious beliefs (0–10 scale) 8.14 (1.79) 8.00 (2.25) 0.32 (0.75)
Gender Male: 22 (52.4) Female: 20 (47.6) Male: 18 (42.9) Female: 24 (57.1) 0.76 (0.38)
Marital status Married: 36 (85.7) Not married: 6 (14.3) Married: 31 (73.8) Not married: 11 (26.2) 1.84 (0.18)
Number of children No child: 4 (9.5) 1–2 children: 18 (42.9) ≥3 children: 20 (47.6) No child: 8 (19.0) 1–2 children: 14 (33.3) ≥3 children: 20 (47.6) 1.83 (0.40)
Educational status Under diploma: 29 (69.0) Diploma: 9 (21.4) Academic degree: 4 (9.5) Under diploma: 18 (42.9) Diploma: 16 (38.1) Academic degree: 8 (19.0) 5.87 (0.05)
Job Unemployed: 16 (38.1) Employed: 14 (33.3) Retired: 12 (28.6) Unemployed: 18 (42.9) Employed: 16 (38.1) Retired: 8 (19.0) 1.05 (0.59)
Perceived economic status Fair: 13 (31.0) Good: 25 (59.5) Very good: 4 (9.5) Fair: 5 (11.9) Good: 27 (64.3) Very good: 10 (23.8) 6.20 (0.045)
Family history of cancer No: 24 (57.1) Yes: 18 (42.9) No: 22 (52.4) Yes: 20 (47.6) 0.19 (0.66)
Insurance No: 2 (4.8) Yes: 40 (95.2) No: 0 (0) Yes: 42 (100) 2.05 (0.15)
Chronic disease history No: 28 (66.7) Yes: 14 (33.3) No: 31 (73.8) Yes: 11 (26.2) 0.51 (0.47)
Admission history No: 11 (26.2) Yes: 31 (73.8) No: 14 (33.3) Yes: 28 (66.7) 0.51 (0.47)
Physical activity Fair: 10 (23.8) Good: 24 (57.1) Very good: 8 (19.0) Fair: 5 (11.9) Good: 31 (73.8) Very good: 6 (14.3) 3.45 (0.33)
Participant flow diagram

https://www.sciencedirect.com/science/article/abs/pii/S1462388925001589

 

Table of variable outcomes' results
Variable Measurement time Groups Between-group comparison t(p) Mean Difference (95% CI) Standardized Mean Difference (95% CI) Repeated measures ANOVA F(p) Partial η²
Loss of meaning Baseline Intervention: 7.06 (5.06) Control: 6.66 (5.04) 0.77 (0.44) 0.81 (-1.29; 2.90) 0.17 (-0.26; 0.60) Time: 8.89 (0.001) 0.110
Follow-up 1 2.68 (3.17) 6.34 (3.22) 23.98 (<0.001) -3.67 (-5.17; -2.18) -1.15 (-1.63; -0.66) Group: 7.90 (0.006) 0.099
Follow-up 2 2.39 (3.21) 5.76 (3.22) 19.94 (<0.001) -3.38 (-4.88; -1.87) -1.05 (-1.53; -0.57) Time*Group: 14.17 (<0.001) 0.164
Disheartenment Baseline 11.18 (5.62) 11.50 (5.70) 0.14 (0.89) 0.17 (-2.23; 2.57) 0.03 (-0.40; 0.46) Time: 16.12 (<0.001) 0.183
Follow-up 1 5.82 (3.44) 10.28 (3.44) 30.48 (<0.001) -4.45 (-6.06; -2.85) -1.30 (-1.79; -0.80) Group: 14.58 (<0.001) 0.168
Follow-up 2 5.39 (3.08) 9.42 (3.04) 31.34 (<0.001) -4.02 (-5.46; -2.59) -1.32 (-1.81; -0.82) Time*Group: 14.59 (<0.001) 0.168
Dysphoria Baseline 9.93 (4.30) 9.83 (4.32) 0.11 (0.91) 0.10 (-1.75; 1.95) 0.02 (-0.41; 0.45) Time: 1.70 (0.19) 0.023
Follow-up 1 7.57 (2.70) 9.94 (2.66) 14.21 (<0.001) -2.37 (-3.62; -1.12) -0.88 (-1.36; -0.41) Group: 7.59 (0.007) 0.095
Follow-up 2 7.24 (2.67) 9.82 (2.60) 17.38 (<0.001) -2.58 (-3.82; -1.35) -0.98 (-1.46; -0.50) Time*Group: 7.05 (0.003) 0.089
Helplessness Baseline 7.30 (3.79) 6.89 (3.78) 0.66 (0.51) 0.52 (-1.06; 2.11) 0.14 (-0.29; 0.57) Time: 0.07 (0.88) 0.001
Follow-up 1 5.77 (2.28) 8.30 (2.27) 22.63 (<0.001) -2.54 (-3.60; -1.48) -1.11 (-1.60; -0.63) Group: 8.14 (0.006) 0.102
Follow-up 2 5.82 (2.29) 8.15 (2.26) 18.96 (<0.001) -2.33 (-3.39; -1.26) -1.02 (-1.50; -0.55) Time*Group: 12.31 (<0.001) 0.146
Sense of failure Baseline 7.01 (2.84) 6.07 (2.82) 1.61 (0.11) 0.98 (-0.23; 2.18) 0.35 (-0.08; 0.78) Time: 15.54 (<0.001) 0.178
Follow-up 1 2.15 (2.28) 5.91 (2.28) 49.20 (<0.001) -3.77 (-4.84; -2.70) -1.65 (-2.17; -1.13) Group: 16.35 (<0.001) 0.185
Follow-up 2 2.30 (2.03) 5.20 (2.01) 36.86 (<0.001) -2.90 (-3.85; -1.95) -1.44 (-1.94; -0.93) Time*Group: 40.15 (<0.001) 0.358
Demoralization (total score) Baseline 42.47 (20.10) 40.95 (20.16) 0.65 (0.52) 2.78 (-5.73; 11.28) 0.14 (-0.29; 0.57) Time: 10.26 (0.001) 0.125
Follow-up 1 23.91 (11.31) 41.16 (11.33) 42.20 (<0.001) -17.25 (-22.55; -11.96) -1.52 (-2.04; -1.01) Group: 11.95 (0.001) 0.142
Follow-up 2 23.26 (10.23) 38.50 (10.12) 40.59 (<0.001) -15.24 (-20.01; -10.47) -1.50 (-2.01; -0.99) Time*Group: 24.26 (<0.001) 0.252
Table of adverse events

We did not encounter any adverse events.

First publication date
2025-08-01, 1404/05/10
Abstract of published paper
Abstract Purpose Demoralization is a common psychological distress experienced by cancer patients undergoing chemotherapy. This study aimed to evaluate the effectiveness of nurse-led dignity therapy in reducing demoralization syndrome among this patient population. Methods A randomized controlled trial was conducted with 84 patients undergoing chemotherapy, who were allocated to either an intervention group (n = 42) receiving three sessions of dignity therapy by a trained oncology nurse, or a control group (n = 42) receiving standard care. Assessments were performed at baseline, one month, and three months post-intervention using a demographic questionnaire and the Demoralization Scale (DS). Data were analyzed using repeated-measures multivariate analysis of variance (MANOVA-RM) to examine changes in demoralization over time and between groups. Results The intervention group showed a significant reduction in demoralization symptoms compared to controls (P < 0.001, standardized mean difference = –1.65). The group-by-time interaction was significant (P = 0.006), indicating that the effects were maintained at follow-up. Conclusions Nurse-led dignity therapy is an effective psychotherapeutic intervention to alleviate demoralization syndrome in patients undergoing chemotherapy. Its integration into oncology nursing practice may enhance psychological outcomes and overall patient care. Keywords: Cancer, Chemotherapy, Dignity Therapy, Demoralization, Nurse-led Intervention
Loading...