1. Home
  2. Approved trials
  3. » فارسی

The impact of a supportive program on family supportive care needs of patients with Colorectal Cancer

Protocol summary

Study aim
The impact of a supportive plan is determined on the family supportive care needs of people with Colon Cancer
Design
A randomized trial with intervention and control group, a sample size of 62 caregivers of patients with colon cancer who referred to Imam Khomeini Hospital in Sari and randomly assigned to one of the intervention or control groups
Settings and conduct
The supportive care needs questionnaire is completed at the time of admission and one month later by the participants. The content of the training sessions is based on the results of the research and is based on authoritative sources and books on colon cancer and approved by the oncology department of the universityin in the project implementation site.
Participants/Inclusion and exclusion criteria
Inclusion criteria are ages between 18 to 80 years, having a relation with the patient (suffering from colon cancer), playing a vital role in patient care, having a willingness to participate in the research. exclusion criteria are Death of the carer, Failure to complete the questionnaire, Patient death
Intervention groups
The intervention group, the family members of the colon cancer patients who will be trained in attendance at the training classes held by the organizers, will have two sessions of training for 1.5 hours, with a two-week interval, and the control group, under the typical training will be provided by health center personnel.
Main outcome variables
The primary outcome of supportive care needs for participants in both groups and the secondary outcomes of their supportive care needs is in different dimensions, which will be compared using the supportive care needs questionnaire (SCNS, P & C39) between the two groups.

General information

Reason for update
Acronym
CRC
IRCT registration information
IRCT registration number: IRCT20171209037796N1
Registration date: 2018-04-21, 1397/02/01
Registration timing: retrospective

Last update: 2018-04-21, 1397/02/01
Update count: 0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Maryam Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4225 4822
Email address
m.hoseini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of a supportive program on family supportive care needs of patients with Colorectal Cancer
Public title
The impact of a supportive program on family supportive care needs of patients with Colorectal Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have a relation with colon cancer patient . Physically and mentally, have the ability to participate in the study and complete the questionnaire Have willing to participate in the study Have a vital role in caring for the patient
Exclusion criteria:
Immigration or the death of the family caregiver during the study Absence in training sessions (two sessions) Failure to complete the research questionnaire Patient death
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Caregivers who have the conditions for participation in the study are included in the target (accessible or simple) sampling and will be randomly assigned as blocks in the intervention (A) and control (B) group. First, 15 blocks of four are defined as follows: ABAB, BBAA, BABA, BAAB, AAAB, ABBA, etc., and then these blocks are arranged randomly and individuals in A and B will be placed in two groups of intervention and control; this will continue until the sample size is completed. Family member A will be placed in the control group and B will be in the control group so that the sequence of samples will be random. After explaining the goals of the study and how the plan will be done for the patient and the family caring for them, oral consent will be given to them for participation in the study. Researchers will be assured that their information will be confidential and can be excluded at any time.
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 Arak University of Medical Sciences
Street address
Basij Sq, Payambar Azam University complex, Emam Mosa Kazem building, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-02-09, 1396/11/20
Ethics committee reference number
IR.ARAKMU.REC.1396.24

Health conditions studied

1

Description of health condition studied
Review the family supportive care needs of people with colon cancer
ICD-10 code
C-18 , C-2
ICD-10 code description
Malignant neoplasm of colon and rectum

Primary outcomes

1

Description
supportive care needs
Timepoint
At the beginning of the study, one month after the intervention
Method of measurement
A Survey of Supporting Care Needs Assessment Questionnaire(SCNS P&C39)

2

Description
Health system & information needs
Timepoint
At the beginning of the study, one month after the intervention
Method of measurement
Health system & information dimension of SCNS-P&C39

3

Description
Psychological needs
Timepoint
At the beginning of the study, one month after the intervention
Method of measurement
Psychological dimension of SCNS-P&C39

4

Description
Job and social needs
Timepoint
At the beginning of the study, one month after the intervention
Method of measurement
Job and social dimension of SCNS-P&C39

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Family members of the colon cancer patients who will be trained in attendance at the training sessions organized by the presenter. The two-week training session will be held for 1.5 hours with a two-week interval, the contents of the protocols' training sessions are based on the results of the research and are based on authoritative references and books on colon cancer and approved by the Oncology Department of the University where the project was implemented. Also, answering the questions of patients in specialized medical fields will be done with an oncologist's consultation and the result will be announced to them.
Category
Other

2

Description
Control group: Family members of patients with colon cancer who undergo routine training provided by health center staff.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Dr Ghasem Janbabaei
Street address
Razi
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
maryamhoseini3@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Mohammad Arjmandzadegan
Street address
Basij Sq, Payambar Azam University complex, Emam Mosa Kazem building, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3502
Email
maryamhoseini3@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Hosseini Joveini
Position
Master Student in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq, Payambar Azam University complex, Blue wing, third floor, Arak
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3417 3502
Email
maryamhoseini3@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazi Nejat
Position
Aistant Proffessor/Nursing Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq, Payambar Azam University complex, Blue wing, third floor, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3502
Email
nazinejat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyedeh Maryam Hosseini Joveini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq, Payambar Azam University complex, Blue wing, third floor, Arak
City
Arak
Province
Markazi
Postal code
38481-7-6941
Phone
+98 86 3417 3502
Email
maryamhoseini3@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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...