To determine the effect of a coaching program based on the integrated coaching theory of nurses on the level of respect for the dignity of patients with cancer.
Design
This study is a parallel randomized controlled clinical trial without blinding.
Settings and conduct
Nurses in the oncology departments of Omid, Shahid Hasheminejad, Ghaem, and Imam Reza hospitals in Mashhad will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups using a randomized block design. The random sequence will be generated by software, and allocation will be concealed with opaque envelopes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Employment in the oncology departments of Omid, Shahid Hasheminejad, Ghaem, and Imam Reza hospitals in Mashhad, at least six months of clinical work experience in oncology departments, Bachelor's degree in nursing or higher
Intervention groups
The intervention group (30 nurses) will receive a self-care coaching program during 8 weekly 30-minute individual sessions in the hospital. The control group (30 nurses) will only complete questionnaires during the same period and will not receive any intervention.
Main outcome variables
The Level of respect for the dignity of cancer patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241206063962N1
Registration date:2025-11-07, 1404/08/16
Registration timing:registered_while_recruiting
Last update:2025-11-07, 1404/08/16
Update count:0
Registration date
2025-11-07, 1404/08/16
Registrant information
Name
Farzaneh Pardehshenas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 2916
Email address
farzaneh.prs96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of the coaching program based on the Integrative Nurse Coaching Theory on the respect for the dignity of cancer patients
Public title
The impact of the coaching on the dignity of cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Employment in the oncology departments of Omid, Shahid Hasheminejad, Ghaem, and Imam Reza hospitals in Mashhad
Bachelor's degree in nursing or higher
At least six months of clinical work experience in the oncology department
Declaration of consent and interest in participating in the research
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized controlled clinical trial. To allocate participants into the intervention and control groups, a block randomization method with blocks of four and an allocation ratio of 1:1 will be used to ensure a balanced distribution between the groups. The randomization sequence will be generated and numbered using Random Allocation Software. The allocation numbers will then be placed in opaque, sealed envelopes, and each participant, upon enrollment in the study, will randomly select one of the envelopes.
This method, in addition to ensuring proper randomization, also guarantees allocation concealment, thereby minimizing the risk of selection bias in assigning participants to the study groups.
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 Committee of School of Nursing & Midwifery, Mashhad University of Medical Sciences
Street address
Nursing and Midwifery School, Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2025-01-21, 1403/11/02
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.087
Health conditions studied
1
Description of health condition studied
The health and well-being of nurses
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Level of respect for the dignity of cancer patients
Timepoint
Completion of a questionnaire to assess the status of respecting patient dignity by nurses before the intervention, in the eighth week of the intervention, and four weeks after the end of the intervention
Method of measurement
Questionnaire to assess the status of respect for patient dignity by nurses
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Thirty nurses from the oncology wards of Omid, Shahid Hasheminejad, Qaem, and Imam Reza Hospitals in Mashhad will participate in a self-care coaching program based on the Integrative Nurse Coaching Theory. The program consists of eight individual weekly sessions, each lasting 30 minutes. Session 1: Conducted face-to-face at the hospital (conference room); includes introduction, rapport building, and completion of demographic forms, the Integrated Health and Wellness Assessment (IHWA), and the Patient Dignity Questionnaire.Sessions 2–8: Delivered individually (face-to-face, by telephone, or online) according to participant preference.Content: Identifying challenges and concerns, setting goals using the SMART technique, developing and implementing action plans, monitoring progress, empowerment, and motivation.Tools: IHWA, Patient Dignity Questionnaire, and an educational booklet based on validated resources (e.g., Nurse Coaching: An Integrative Approach to Health and Wellbeing).Features: Make-up sessions will be arranged if needed, goals can be revised collaboratively, and participants’ progress will be monitored regularly.
Category
Lifestyle
2
Description
Control group: Thirty nurses in the control group will only complete the study questionnaires at designated times and will not receive any intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Elahe Ramezanzade Tabriz
Street address
Alandasht Crossroads, Kohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Email
Ramezanzadehe@mums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Elahe Ramezanzadeh Tabriz
Street address
Imam Reza Square, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Ramezanzadehe@mums.ac.ir
3
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Elahe Ramezanzadeh Tabriz
Street address
Ghaem Hospital, Ahmad Abad Street, Taghi Abad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Email
Ramezanzadehe@mums.ac.ir
4
Recruitment center
Name of recruitment center
Shahid Hasheminejad Hospital
Full name of responsible person
Elahe Ramezanzadeh Tabriz
Street address
Shahid Mofateh Street, End of Abu Raihan Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۵۵٧٨٨٨۶٩
Phone
+98 51 3272 2322
Email
Ramezanzadehe@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice President for Research and Technology, Qorashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Pardehshenas
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Taslimi 3, 40 North Motahari St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687141
Phone
+98 51 3728 2916
Email
Farzaneh.prs96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Ramezanzade Tabriz
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Martyr Dr. Kharazmi Educational Building, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Email
Ramezanzadehe@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Pardehshenas
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Taslimi 3, 40 North Motahari St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9194687141
Phone
+98 51 3728 2916
Email
Farzaneh.prs96@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
The dataset comprises detailed information on nurses’ demographic variables (age, gender, and educational level), work schedules, indicators of health and well-being, and measures of respect for the dignity of cancer patients across both intervention and control groups.
When the data will become available and for how long
Six months after the study results were published
To whom data/document is available
People working in scientific, research, and academic institutions who need this data for scientific research.
Under which criteria data/document could be used
People who need this data for scientific research.
From where data/document is obtainable
Elahe ramezanzade tabriz
Ramezanzadehe@mums.ac.ir
What processes are involved for a request to access data/document
First, an email requesting data will be sent to Dr. Elahe Ramezanzade Tabriz, and after approval, the data will be sent.