Investigating the effectiveness of spiritual palliative care guidelines in patients with cancer
Design
A parallel two-group clinical trial involving 44 patients
Settings and conduct
This study will be conducted on cancer patients at Beheshti Hospital in Hamedan in 2025. Blinding is not possible in this study and the study will be conducted as an open-label study. The researcher will visit the operating room department of Beheshti Hospital in two shifts, morning and evening. After grouping the patients into two groups randomly and following specific instructions, the desired variables will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 60 years, Having colon, breast, or prostate cancer, having been diagnosed with cancer for at least 6 months, no known mental illness, no physical illness other than cancer, no sensory impairments such as vision or hearing problems affecting learning.
Exclusion criteria: Using addictive substances, having diseases other than cancer
Intervention groups
In this study, the intervention group includes 22 patients who will be given spiritual palliative care instructions during 8 one-hour sessions (Introduction and exploration of meaning and values - Connection with the higher self and the source of faith - Meditation through prayer and book therapy - Finding meaning in suffering and illness - Connection with others and a sense of belonging - Trust, hope, and patience in the face of limitations - Identity and its promotion and self-help practice - Conclusion and integration). Patients in the control group will receive only routine care and spiritual palliative care guidelines will not be applied to them.
Main outcome variables
Patients' quality of life, cancer patients' perception of the quality of palliative care, consequences of providing palliative care to patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230129057271N5
Registration date:2025-12-12, 1404/09/21
Registration timing:prospective
Last update:2025-12-12, 1404/09/21
Update count:0
Registration date
2025-12-12, 1404/09/21
Registrant information
Name
Sina Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 8792
Email address
sinaghasemi19980@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of spiritual palliative care guidelines in patients with cancer
Public title
Applying spiritual palliative care guidelines in patients with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years old
Having sufficient literacy skills to complete the survey
Cancer diagnosis for at least 6 months
Lack of known mental illness
Willingness to voluntarily participate in the study
Failure to participate in other related educational programs
Lack of sensory impairments, such as vision or hearing problems, that affect learning
Having colon, breast, or prostate cancer
Exclusion criteria:
Use of addictive substances
Having diseases other than cancer
Occurrence of a specific incident before the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients in two groups will be done in random blocks so that; The block size is equal to 4. The randomization tool in this research will be the use of four envelopes containing two sheets A and two sheets B, each time by removing one of the sheets, the patient will be placed in the intervention or control group. The removed sheets will not be returned to the envelope until the 4 sheets are finished. After determining the assignment of the first 4 patients, the sheets are returned to the envelope and the next 4 patients will continue in this way until the sample size is completed.
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
Research Ethics Committees of Baqiyatallah Hospital
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۶۴۷۱
Approval date
2025-10-06, 1404/07/14
Ethics committee reference number
IR.BMSU.BAQ.REC.1404.097
Health conditions studied
1
Description of health condition studied
Colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
2
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
3
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Quality of life of patients
Timepoint
At the beginning of the study (before intervention) and after the last session of implementing spiritual palliative care guidelines
Method of measurement
Using the Missoula – VITAS quality of life index (MVQOLI)
2
Description
Patients' perceptions of the quality of palliative care
Timepoint
After the last session of implementing spiritual palliative care guidelines
Method of measurement
Using the patients' perspectives of the quality of palliative care questionnaire
3
Description
Incidence of palliative care outcomes
Timepoint
After the last session of implementing spiritual palliative care guidelines
Method of measurement
Using the Palliative Care Outcome Scale (POS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During this study, the intervention group included patients who would receive spiritual palliative care from a nurse. Spiritual palliative care instructions will be provided to them over 8 sessions (Titles: Introduction and exploration of meaning and values - Connection with the higher self and the source of faith - Meditation through prayer and book therapy - Finding meaning in suffering and illness - Connection with others and a sense of belonging - Trust, hope, and patience in the face of limitations - Identity and its promotion and self-help practice - Conclusion and integration), and patients will be taught the relevant materials. These materials will be presented to patients in accordance with the titles mentioned and solely based on spiritual therapy and with the aim of spirituality in patients. In each session, the researcher will be present at the patient's bedside and in the inpatient ward for one hour and will teach or share relevant matters with the patient, and at the end of the session, the assignments related to the session will be handed over to the patient. During this study, each session will be held in a separate week. This guideline was developed by the researchers involved in the study, and its face and content validity was reviewed by university faculty members.
Category
Other
2
Description
Control group: In this study, the control group includes patients who will only receive routine nursing care and will not receive spiritual palliative care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Seyed Morteza Hosseini
Street address
Beginning of Eram Boulevard, Ghaem Square, Hamedan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 901 669 0780
Email
sm_hosseini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Abbas Ali Imani Fooladi
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۶۴۷۱
Phone
+98 901 669 0780
Email
researchcenter@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Morteza Hosseini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۶۴۷۱
Phone
+98 901 669 0780
Email
sm_hosseini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Morteza Hosseini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۶۴۷۱
Phone
+98 901 669 0780
Email
sm_hosseini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Morteza Hosseini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai, Mulla Sadra Street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۶۴۷۱
Phone
+98 901 669 0780
Email
sm_hosseini@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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