Protocol summary

Study aim
Investigating the Impact of Cancer Survivors' Experience on Rescuing Patients with Cancer
Design
Clinical trial with control group
Settings and conduct
At the first session, the test and control group is invited to introduce and complete the questionnaire. In this meeting, before the data are collected, the research objectives for the participants will be fully explained. The second, third, fourth and fifth sessions will be held with the experience of the survivors. At the sixth session, a separate intervention and control group will be invited to refer to the completed questionnaire to complete.
Participants/Inclusion and exclusion criteria
1. Conscious and written consent for participation in the study 2. Ability to attend meetings 3. Not having a history of other chronic diseases 4. Non-cancer in first-degree people 5. Age 60-20 years 6. Lack of participation in psychological training simultaneously 7. Getting involved in stage 2 or 3 cancer
Intervention groups
Patients participating in the research were randomly assigned to two groups of test (30 people) and control (30 people). Four survivors of cancer speak in a friendly and desirable environment based on their experiences of cancer, diagnosis, treatment, complications and self-care and adaptation to cancer, the effects of chemotherapy, nutrition, exercise, physical image, communication, and health issues. Patients in the test group participated in one of the four 120-minute training sessions once a week and are subject to an independent variable (surviving cancer). 20% of the final time of each session will be allocated to the free discussion. During this period, the control group will receive routine treatment.
Main outcome variables
resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180801040663N1
Registration date: 2018-10-01, 1397/07/09
Registration timing: retrospective

Last update: 2018-10-01, 1397/07/09
Update count: 0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Zahra Mollaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
mollaei-z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Cancer Survivors' experiences on resilience of cancer patients
Public title
Investigating the effect of Peer group experiences on resilience of cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Ability to participate in the sessions Being involved in stage 2 or 3 cancer
Exclusion criteria:
having a history of other chronic diseases have cancer in first-degree people participating in psychological training simultaneously
Age
From 20 years old to 60 years old
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
Random assignment has been blocked so that first four blocks of letters A, B are prepared and randomly selected using the random numbers of numbers 1-6 and based on their choice, a sequence of letters A and B is correct and Each patient, according to the entry number to the plan, is one of the A and B breeds.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences and Health Services
Street address
Faculty of Nursing, pezesk Blvd, Midwifery., Ghotb Ravandi Blvd., Kashan, Isfahan,
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-06-19, 1397/03/29
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.013

Health conditions studied

1

Description of health condition studied
resilience
ICD-10 code
ICD-10 code description

2

Description of health condition studied
cancer
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Peer group
ICD-10 code
ICD-10 code description

4

Description of health condition studied
Cancer Survivors'
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Connor and Davidson Resilience Questionnaire
Timepoint
Resiliency measure at the beginning of the study (before the intervention) and one month after the start of the study
Method of measurement
Connor and Davidson Resilience Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group, Thirty patients, is selected to receive chemotherapy or radiotherapy, and then participate in four 90-minute sessions. At each session, there is a cancer survivor who will talk about his or her treatment experience. Assesment of this intervention will be carried out in the form of a pre-test and a Post-test.
Category
Rehabilitation

2

Description
Control group: The group continues to receive routine treatment, and will be selected only for this group of pre-test and post-test.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Yaseri Specialty Hospita
Full name of responsible person
Fatemeh Sadat Izadi Onji
Street address
Ayatollah Yaseri Specialty Hospital- Nursing Blvd - Kahan Blvd. Rowundi
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 5000
Fax
+98 31 5562 1530
Email
info@yasrebihospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
دکتر غلامعلی حمیدی
Street address
Faculty of Nursing, Pezesk Blvd, Midwifery., Ghotb Ravandi Blvd., Kashan, Isfahan,
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Izadi - Avanj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, pezesk Blvd, Midwifery., Ghotb Ravandi Blvd., Kashan, Isfahan,
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
fs.izadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Izadi-Avangi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, pezesk Blvd, Midwifery., Ghotb Ravandi Blvd., Kashan, Isfahan,
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
izadi_fs@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Izadi-Avangi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, pezesk Blvd, Midwifery., Ghotb Ravandi Blvd., Kashan, Isfahan,
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
izadi_fs@kaums.ac.ir

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
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
It is reported in the form of a thesis.
When the data will become available and for how long
Summer of 2019
To whom data/document is available
everybody
Under which criteria data/document could be used
توسعه دانش
From where data/document is obtainable
دانشگاه علوم پزشکی کاشان
What processes are involved for a request to access data/document
مراجعه به معونت پژوهشی دانشگاه و سپس مسئول تحقیق .
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