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The effect of community-based palliative support interventions integrated with primary health care (PHC) on caregivers' anxiety, depression and workload and death anxiety of patients with advanced cancer

Protocol summary

Study aim
Determining the impact of community-based palliative support interventions integrated with primary health care (PHC) on the anxiety, depression and workload of caregivers and death anxiety of patients with advanced cancer
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized using a table of random numbers. Sampling will be done in selected comprehensive health service centers, which are in the northern and central part of Khorram Abad city. Comment will be placed.
Settings and conduct
The doctor determines the patient, with the presence of the student and the caregiver at the comprehensive health service center in the first week after the introduction of the patient and the family, they will get to know the team members including the doctor, psychologist, nurse and nutritionist, then the nurse 2 weeks later through the health center He will go to the patient's home and provide necessary training and interventions based on their care needs. At the end of three months and 4 to 6 weeks after the completion of the interventions, the questionnaire will be provided to the test group
Participants/Inclusion and exclusion criteria
Entry requirements: willingness to participate in the study, having a health record in comprehensive health centers; age group between 18 and 75 years; alert to time and place; Non-entry conditions: participation in similar training courses; lack of consciousness to time and place; It is not possible for the patient to attend the training sessions
Intervention groups
Intervention group: After familiarizing the family and the patient with the nurse, a home visit is conducted and necessary training is given according to their needs. Control group: routine care without training
Main outcome variables
anxiety, depression, caregiver burden, death anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180721040540N6
Registration date: 2024-05-27, 1403/03/07
Registration timing: registered_while_recruiting

Last update: 2024-05-27, 1403/03/07
Update count: 0
Registration date
2024-05-27, 1403/03/07
Registrant information
Name
Heshmatolah Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0160
Email address
heidari.h@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of community-based palliative support interventions integrated with primary health care (PHC) on caregivers' anxiety, depression and workload and death anxiety of patients with advanced cancer
Public title
The effect of community-based palliative support interventions integrated with primary health care (PHC) on caregivers' anxiety, depression and workload and death anxiety of patients with advanced cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria for cancer patients: 1- The patient's age should be 18 to 75 years. 2- Patients with advanced cancer based on expert opinion. 3- Be aware of time and place and have consent to participate in the study. 4- Do not have cognitive, vision or hearing problems 5- The patient should have a family caregiver. 6- Have a health file in comprehensive urban health service centers of Khorram Abad city. 7- The patient is undergoing treatment (radiotherapy, chemotherapy, etc.) or has referred to an oncologist to start treatment. 8- The patient is considered to be in the 4th stage of cancer (any type of this disease) diagnosed by a specialist doctor. Entry criteria for caregivers of cancer patients: 1- Caregiver age should be 18 to 75 years. 2- Consent to participate in the study. 3- Do not have cognitive, vision or hearing problems. 4- A definite diagnosis of one of the types of cancer has been established in a first-degree family member 5- Live with the patient.
Exclusion criteria:
1- Lack of awareness of time and place in the patient or caregiver. 2- Impossibility of the patient or caregiver to attend the training sessions. 3- Having vision, hearing and cognitive problems for the patient or caregiver.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 148
Randomization (investigator's opinion)
Randomized
Randomization description
According to the provided list of qualified people from health centers, using a table of random numbers, moving from top to bottom even codes for the control group and odd codes for the intervention group as an example in are considered and this work continues until reaching the sample size for two 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
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Kamalvand Road, Khorramabad, Borujerd, km 5
City
khoramabad
Province
Lorestan
Postal code
6814993165
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.LUMS.REC.1402.378

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

2

Description of health condition studied
cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms

3

Description of health condition studied
Supportive treatment
ICD-10 code
Z51.5
ICD-10 code description
Encounter for palliative care

4

Description of health condition studied
depression
ICD-10 code
F06.32
ICD-10 code description
Mood disorder due to known physiological condition with major depressive-like episode

5

Description of health condition studied
caregivers' burden
ICD-10 code
ICD-10 code description

6

Description of health condition studied
death anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Palliative care
Timepoint
3 months, a week before, a month after
Method of measurement
The score obtained from the Palliative Performance Scal

2

Description
anxiety
Timepoint
3 months, a week before, a month after
Method of measurement
The score obtained from the Beck Anxiety Inventory

3

Description
depression
Timepoint
3 months, a week before, a month after
Method of measurement
The score obtained from the Beck depression Inventory

4

Description
death anxiety
Timepoint
3 months, a week before, a month after
Method of measurement
The score obtained from the Templer Death Anxiety Questionnaire

5

Description
caregivers' burden
Timepoint
3 months, a week before, a month after
Method of measurement
The score obtained from the Novak and Gust care burden questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The starting point of this intervention is the diagnosis of cancer for the patient by oncologists in specialized centers. With the guidance of the oncologist, the patient's file (electronically or manually) is referred to the city health center, and from there, the patient's file is referred to the comprehensive health center of the patient's place of residence through the Sib system or automation. The different phases of the disease, including the supportive and palliative phase, will be determined by the oncologist based on existing guidelines. At first, the patient receives care related to the supportive phase. Over time and with the progress of the disease, the patient will enter the palliative support phase. After referral, if the patient has a PPS of more than 40, he himself goes to the comprehensive health center of his place of residence with the summary of the case. they do. The doctor of the center determines the patient's needs in different physical, mental, social and spiritual dimensions after the examination and the necessary investigations, and then based on that, a care plan is considered for the patient. This care will continue until the patient needs hospital and specialized services, and the patient will be referred to higher levels through the researcher. The basis of the model will be done. In this way, the diagnosis of the patient and the registration of his information in comprehensive centers and in the Sib system have already been registered. After identifying the patients through the Sib system, the patient or the patient's family is contacted. And the patient and his caregiver are invited to the comprehensive health center for initial evaluation. The patient is subjected to initial physical, psychological, social, economic and spiritual evaluation by the doctor based in the center and also the nurse (researcher), and his needs are determined in all these dimensions. Also, in this meeting, the patient and the family will get to know the team members, including nurses, psychologists, doctors and nutritionists working in the comprehensive health center, and the necessary information will be collected by other experts and the necessary training will be given to the patient and the family. In this meeting, the researcher will explain to the patient and family the structure of comprehensive health service centers, capacities and how to access these services based on the type of cancer, the prognosis of the disease, the needs of the patient, the care that should be done for him. Two weeks after the introduction, the nurse will visit the patient's home again through comprehensive health service bases and provide the necessary interventions and training to the patient and the patient's family based on the patient's condition and care needs. Home visit once every two weeks (of course, depending on the patient's conditions) will be done through the channel of comprehensive health service bases, for three months from the time of the patient's entry into the study. From the beginning of the palliative treatment, the patient and the family will be able to communicate with the nurse through authorized social media messages such as ETA as well as by phone and receive answers to their questions from the health staff. In the numerous meetings held with the presence of the patient and his family, things such as the diagnosis of patients' care needs, the nature of cancer, chemotherapy, radiotherapy and the importance of self-care will be discussed. Also, it will be discussed about digestive complications, problems related to skin, hair, fatigue, shortness of breath, pain, diarrhea, and vomiting, and proposed solutions to reduce and control these complications, as well as ways to improve the patient's adaptation in the field of social, family, and psychological issues. . A training booklet on how to care for the patient will be provided to the intervention group. In addition to the educational and care services provided to the patient, the potential of other people present in the centers such as doctors, psychologists and nutritionists will also be used. At the end of three months and also 4-6 weeks after the completion of the interventions (to evaluate the sustainability of the interventions), the questionnaires will be provided to the test group and the questionnaires will be completed again.
Category
Lifestyle

2

Description
Control group: During the research period, the control group received their usual care from health service providers and no intervention will be done for them by the research team.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences
Full name of responsible person
Heshmatullah Heydari
Street address
5 kilometers of Khorram Abad Borujard road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0174
Fax
+98 66 3312 0173
Email
Heidari.H@Lums.ac.ir
Web page address
http://research.lums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research assistant of Lorestan University of Medical Sciences
Full name of responsible person
Bahram Kamrei
Street address
5 km of Khorram Abad-Boroujerd road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
research@lums.ac.ir
Web page address
http://research.lums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistant of Lorestan 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatullah Heydari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5 km of Khorram Abad-Boroujerd road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
Hidari74@gmail.com
Web page address
http://research.lums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatullah Heydari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5 km of Khorram Abad-Boroujerd road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 1233 0174
Fax
+98 66 1233 0173
Email
hidari74@gmail.com
Web page address
http://research.lums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Heshmatullah Heydari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5 km of Khorram Abad-Boroujerd road
City
Khorramabad
Province
Lorestan
Postal code
68149-93165
Phone
+98 66 1233 0174
Fax
+98 66 1233 0173
Email
hidari74@gmail.com
Web page address
http://research.lums.ac.ir/

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
No - There is not 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 final thesis report and questionnaires are shared
When the data will become available and for how long
After registering the thesis and publishing the articles related to the project
To whom data/document is available
The research team, the university's research officials, the supervisors' plan, the editors of specialized journals of researchers in the field of medical sciences
Under which criteria data/document could be used
Conducting research to improve the quality of life of cancer patients and their families
From where data/document is obtainable
Responsible researcher
What processes are involved for a request to access data/document
Coordinating with the researcher via e-mail, referring to the library of the Nursing Faculty of Lorestan University of Medical Sciences
Comments
Special cases are not considered
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