Protocol summary

Study aim
The aim of this study is to determine the effectiveness of narrative therapy on dignity and meaning in life among older adults with cancer requiring palliative care who are hospitalized in oncology wards of hospitals affiliated with Kerman University of Medical Sciences.
Design
A parallel-group clinical trial with a pretest-posttest design comparing the effect of narrative therapy on dignity and meaning in life between intervention and control groups.
Settings and conduct
This study will be conducted in the oncology wards of Afzalipour, Shafa, and Bahonar hospitals affiliated with Kerman University of Medical Sciences. After obtaining the required ethical approvals and administrative permissions and coordinating with the relevant authorities, the researcher will identify eligible older adults with cancer through regular visits to the oncology wards. After obtaining written informed consent, eligible participants will be enrolled in the study. Following baseline assessment, participants will be randomly allocated to the intervention and control groups. Narrative therapy will be provided to participants in the intervention group through individual sessions at the patient’s bedside by a trained therapist. Participants in the control group will receive routine oncology care and standard palliative care. Study outcomes will be assessed in both groups before and after the intervention.
Participants/Inclusion and exclusion criteria
The participants of this study will be older adults aged 60 years and above with cancer requiring palliative care who are hospitalized in the oncology wards of hospitals affiliated with Kerman University of Medical Sciences.
Intervention groups
Receiving individual narrative therapy along with routine care to enhance meaning in life and dignity.
Main outcome variables
Changes in patient dignity and meaning in life scores after the narrative therapy intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260801070485N1
Registration date: 2026-08-10, 1405/05/19
Registration timing: prospective

Last update: 2026-08-10, 1405/05/19
Update count: 0
Registration date
2026-08-10, 1405/05/19
Registrant information
Name
zahra khalilzadeh-farsangi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3253 3987
Email address
zahrakhlilzde@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-11, 1405/05/20
Expected recruitment end date
2027-03-11, 1405/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Narrative Therapy on Dignity and Meaning in Life Among Elderly Cancer Patients with Palliative Care Needs Hospitalized in Oncology Wards
Public title
The Effect of Conversation and Life Storytelling on the Sense of Dignity and Meaning in Life Among Older Adults with Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have a confirmed diagnosis of cancer based on medical records. Be hospitalized in the oncology wards of hospitals affiliated with Kerman University of Medical Sciences. Have a need for receiving palliative care. Have the ability to communicate verbally and participate in narrative therapy sessions. Have sufficient cognitive awareness to answer questions and complete research instruments. Provide written informed consent to participate in the study. Having an age between 60 and 80 years
Exclusion criteria:
Having severe cognitive impairment or dementia based on medical records or initial assessment. Having severe psychiatric disorders that affect the ability to participate in the study. Being unable to establish appropriate verbal communication. Receiving concurrent similar psychological interventions (such as narrative therapy or life review therapy). Having an unstable or critical physical condition that prevents participation in intervention sessions.
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants will be allocated to the intervention and control groups using simple randomization. The unit of randomization will be the individual participant, and after entering the study and completing the baseline assessment process, each participant will be assigned to either the intervention group (receiving narrative therapy) or the control group. The random allocation sequence will be generated using a random number generation software. To ensure allocation concealment, the allocation sequence will be prepared by an independent person who is not involved in the implementation or assessment of the study and will be kept in opaque, sealed, and sequentially numbered envelopes. After the participant’s final inclusion in the study, the corresponding envelope will be opened and the assigned group will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the narrative therapy intervention, blinding of participants and the intervention provider is not feasible, as participants will be aware of whether they have received the intervention sessions. In addition, the principal researcher and the person delivering the intervention will be aware of participants’ group allocation. However, the data collector and outcome assessor will be blinded to participants’ allocation to the intervention and control groups. The post-intervention questionnaires will be completed and recorded by an outcome assessor who is not involved in the intervention process to minimize the risk of assessment bias. If possible, data analysis will also be performed using coded groups (e.g., Group A and Group B) without revealing the actual group assignments to the data analyst.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7617787177
Approval date
2026-07-20, 1405/04/29
Ethics committee reference number
IR.KMU.REC.1405.196

Health conditions studied

1

Description of health condition studied
Cancer (in older adults requiring palliative care)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Patient dignity score measured using the Patient Dignity Inventory (PDI) before and after the narrative therapy intervention, and changes will be compared between the intervention and control groups.
Timepoint
Outcome variables will be measured at two time points: before the intervention (pre-test) and immediately after completion of the narrative therapy intervention (post-test, at the end of the fourth week).
Method of measurement
Patient Dignity Inventory, a 25-item questionnaire used to assess dignity-related distress among patients with life-threatening illnesses.

2

Description
Meaning in life score measured using the Meaning in Life Questionnaire (MLQ) before and after the narrative therapy intervention, and changes will be compared between the intervention and control groups.
Timepoint
Outcome variables will be measured at two time points: before the intervention (pre-test) and immediately after completion of the narrative therapy intervention (post-test, at the end of the fourth week).
Method of measurement
Meaning in Life Questionnaire, a questionnaire assessing two dimensions of meaning in life, including presence of meaning and search for meaning.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in this group will receive individual narrative therapy in addition to routine oncology care and standard palliative care. The intervention will be delivered by a psychologist trained in narrative therapy based on the White and Epston framework.The intervention consists of eight individual sessions lasting 45–60 minutes, conducted twice weekly over four consecutive weeks at the patient's bedside in the oncology ward.The sessions include establishing a therapeutic relationship and collecting the patient's life narrative, externalizing the illness from the patient's identity, identifying unique outcomes and meaningful life experiences, reconstructing the patient's life story focusing on meaning, strengths, achievements, and valuable relationships, and preparing a written reconstructed life narrative document.Post-test assessments will be conducted after completion of the eighth session.
Category
Lifestyle

2

Description
Control group: Participants in this group will receive only routine oncology care and standard palliative care. Usual care includes routine medical and nursing interventions, symptom management, pain control, management of cancer-related symptoms, and routine psychosocial support provided in the ward.No structured psychological intervention or narrative therapy will be provided during the study period. After completion of data collection, narrative therapy will be offered to participants in the control group for ethical considerations.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Zahra Khalilzadeh-Farsangi
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76177877
Phone
+98 34 3253 3654
Email
zahrakhlilzde@gmail.com

2

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Samaneh Fallah-Karimi
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7617787177
Phone
+98 34 2354 6787
Email
sfallah084@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Maroufi
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
76177878
Phone
+98 34 3253 6765
Email
m.maroufi@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zahra Khalilzadeh-Farsangi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7617787177
Phone
+98 34 2345 6789
Email
zahrakhlilzde@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Khalilzadeh-Farsangi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7617787177
Phone
034332533787
Email
zahrakhlilzde@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Khalilzadeh-Farsangi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7617787177
Phone
+98 34 3253 4567
Email
zahrakhlilzde@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
Individual participant data will not be shared due to confidentiality and privacy considerations and the sensitive nature of clinical information of patients with cancer.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol and final study report, including study objectives, methodology, study design, intervention details, measurement tools, and main findings, will be shared after completion of the study.
When the data will become available and for how long
Access to the documents will be available from 6 months after publication of the main study results in a scientific journal.
To whom data/document is available
Researchers, academic staff, and investigators affiliated with scientific or academic institutions can request access to the documents.
Under which criteria data/document could be used
The documents can be used only for scientific and research purposes, including designing related studies, evidence synthesis, and advancing knowledge in palliative care and psychological interventions. Use of the documents must comply with research ethics principles and respect intellectual property rights.
From where data/document is obtainable
Applicants can submit their requests by contacting the principal investigator of the study or the relevant research center/Kerman University of Medical Sciences.
What processes are involved for a request to access data/document
Requests for access to the documents will be reviewed by the principal investigator. After approval of the scientific purpose of the request and confirmation of ethical considerations, access to the relevant documents will be provided.
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