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The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer in Amir Shiraz Hospital

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History
# Registration date Revision Id
2 2019-03-02, 1397/12/11 81617
1 2019-01-27, 1397/11/07 76932
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  • General information

    empty
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    2019-01-27, 1397/11/07
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    2019-02-16, 1397/11/27
    Patients who are at stage 1 and 2 and 3 of their illness
    Patients who are aware of their diagnosis
    Patients who have at least one chemotherapy course
    Patients at the minimum functional level
    Age between 25 and 75 years
    Complete mental health
    Willingness to cooperate
    Not suffering from other diseases except colon cancer
    Having minimal spiritual beliefs
    Lack of vision and hearing problems
    عدم سابقه استفاده از مراقبت تسکینی مبتنی بر معنویت
    Patients who are at stage 1 and 2 and 3 of their illness
    Patients who are aware of their diagnosis
    Patients who have at least one chemotherapy course
    Patients at the minimum functional level
    Age between 25 and 75 years
    Complete mental health
    Willingness to cooperate
    Not suffering from other diseases except colon cancer
    Having minimal spiritual beliefs
    Lack of vision and hearing problems
    Lack of experience using palliative care base on spirituality

  • Intervention groups

    #1
    Intervention group: First , after a course of chemotherapy ,questionnaires will distributed between 36 member of the intervention group .Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group.The interval between chemotherapy courses is usually two weeks . And every patient needs ten to twelve weeks of chemotherapy , depending on the severity of the patient's disease and physician's discretion.The training program(The curriculum) consists of 6 sessions ,that each session takes an average of 2 hours.Currently, this curriculum includes the following:first session: recitation of verses from Qur'an. second session: praying and discussing the psychological effects of praying. third session: Peer group discussions focused on God ,relationship with Yourself ,others and nature. Fourth session: The Spiritual Authority 's Speech. fifth session: Play religious clips sixth session: group praying .After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month. The intervention group may be divided into two groups of 18 member During interventions.
    Intervention group: First , after a course of chemotherapy ,questionnaires will distributed between 36 member of the intervention group .Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group.The interval between chemotherapy courses is usually two weeks . And every patient needs ten to twelve weeks of chemotherapy , depending on the severity of the patient's disease and physician's discretion.The training program(The curriculum) consists of 7 sessions ,that each session takes an average of 1 hours. this curriculum includes the following: Session One: playing verses from the Holy Quran. Second Session: playing prayer and group chants. Session 3: Spiritual and peer-based Support,Talking to Patients about communication with God, your self, Others and Nature.Session Four: Playing Religious video Clips.Session 5: Spiritual Advice.Session Six: Nutrition Advice.Seventh Session: Mental Advice. After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month.
    گروه مداخله: ابتدا پس از اتمام یک دوره شیمی درمانی، پرسش نامه ها بین 36 نفر از اعضای گروه مداخله توزیع می شود. سپس در زمان مراجعه بیماران برای دوره شیمی درمانی بعدی، برنامه آموزشی آغاز می گردد. فاصله بین دوره های شیمی درمانی معمولا 2 هفته است و هر بیمار بسته به شدت بیماری و صلاحدید پزشک معالج به 10 تا 12 دوره شیمی درمانی نیاز دارد. برنامه آموزشی شامل 6 جلسه‌ است که هر جلسه به طور میانگین 2 ساعت زمان می‌برد. در حال حاضر این برنامه آموزشی شامل موارد زیر است:- جلسه اول : قرائت آیاتی از قران کریم- جلسه دوم: خواندن دعا و بحث در مورد اثرات روانی خواندن دعا- جلسه سوم: بحث های گروهی همتا با محوریت ارتباط با خدا، ارتباط با خود، ارتباط با دیگران و ارتباط با طبیعت- جلسه چهارم: سخنرانی فرد روحانی - جلسه پنجم: پخش کلیپ های مذهبی- جلسه ششم: مناجات گروهی .پس از اتمام دوره آموزشی و در جلسه آخر، پرسش نامه ها بلافاصله و نیز یک ماه بعد، توزیع می شود. ممکن است گروه مداخله در زمان اجرای مداخلات به دو گروه 18 نفره تقسیم شود.
    گروه مداخله: ابتدا پس از اتمام یک دوره شیمی درمانی، پرسش نامه ها بین 36 نفر از اعضای گروه مداخله توزیع می شود. سپس در زمان مراجعه بیماران برای دوره شیمی درمانی بعدی، برنامه آموزشی آغاز می گردد. فاصله بین دوره های شیمی درمانی معمولا 2 هفته است و هر بیمار بسته به شدت بیماری و صلاحدید پزشک معالج به 10 تا 12 دوره شیمی درمانی نیاز دارد. برنامه آموزشی شامل7 جلسه‌ است که هر جلسه به طور میانگین 1 ساعت زمان می‌برد. برنامه آموزشی شامل موارد زیر است:-جلسه اول : پخش آیاتی از قرآن کریم- جلسه دوم: پخش دعا و مناجات گروهی-جلسه سوم: حمایت معنوی و همتامحور و صحبت کردن با بیماران حول ارتباط با خدا، ارتباط با خود، ارتباط با دیگران و ارتباط با طبیعت-جلسه چهارم: پخش کلیپ های مذهبی -جلسه پنجم:مشاوره معنوی -جلسه ششم: مشاوره تغذیه-جلسه هفتم: مشاوره روان. پس از اتمام دوره آموزشی و در جلسه آخر، پرسش نامه ها بلافاصله و نیز یک ماه بعد، توزیع می شود.
    #2
    Control group: First, after completing a chemotherapy course, questionnaires are distributed among the control group members.Then, after the last session of the intervention group, the control group will receive only a series of educational pamphlets related to spirituality-based relief care after completing their chemotherapy.
    Control group: First, after completing a chemotherapy course, questionnaires are distributed among the control group members.Then, at the time of the referral of patients for the next chemotherapy course, these patients will receive only a series of educational pamphlets related to palliative care based on spirituality.
    گروه کنترل: ابتدا پس از اتمام یک دوره شیمی درمانی، پرسش نامه ها بین اعضای گروه کنترل توزیع می شود. سپس پس از آخرین جلسه آموزشی گروه مداخله، گروه کنترل تنها یک سری پمفلت های آموزشی در ارتباط با مراقبت تسکینی مبتنی بر معنویت پس از اتمام دوره شیمی درمانی خود دریافت می کنند.
    گروه کنترل: ابتدا پس از اتمام یک دوره شیمی درمانی، پرسش نامه ها بین اعضای گروه کنترل توزیع می شود. سپس در زمان مراجعه برای دوره شیمی درمانی بعدی، این دسته از بیماران تنها یکسری پمفلت های آموزشی در ارتباط با مراقبت تسکینی مبتنی بر معنویت، دریافت می کنند.

  • Recruitment centers

    #1
    Name of recruitment center - English: Amir oncology hospital
    Name of recruitment center - Persian: بیمارستان انکولوژی امیر
    Full name of responsible person - English: parisa sabet sarvestani
    Full name of responsible person - Persian: پریسا ثابت سروستانی
    Street address - English: Farhang shahr, Rajaei Blvd, infront of Kowsar Water Park
    Street address - Persian: فرهنگ شهر- ایستگاه 11-بیمارستان انکولوژی امیر
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7187915998
    Phone: +98 71 3632 3532
    Fax:
    Email: amirhp@sums.ac.ir
    Web page address: https://amirhosp.sums.ac.ir/page-amirhp/fa/36/form/pId6915
    Name of recruitment center - English: Amir Oncology Hospital
    Name of recruitment center - Persian: بیمارستان انکولوژی امیر
    Full name of responsible person - English: Parisa Sabet Sarvestani
    Full name of responsible person - Persian: پریسا ثابت سروستانی
    Street address - English: Farhang shahr, Rajaei Blvd, Infront of Kowsar Water Park
    Street address - Persian: فرهنگ شهر- ایستگاه 11- بیمارستان انکولوژی امیر
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7187915998
    Phone: +98 71 3632 3532
    Fax:
    Email: Amirhp@sums.ac.ir
    Web page address: Https://amirhosp.sums.ac.ir/page-amirhp/fa/36/form/pId6915

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: DR. mojtaba farjam
    Full name of responsible person - Persian: دکتر مجتبی فرجام
    Street address - English: Ibn Sina Square
    Street address - Persian: میدان ابن سینا، دانشگاه علوم پزشکی فسا
    City - English: Fasa
    City - Persian: فسا
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7461686688
    Phone: +98 71 5335 0994
    Fax:
    Email: research@fums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: DR. Mojtaba Farjam
    Full name of responsible person - Persian: دکتر مجتبی فرجام
    Street address - English: Ibn Sina Square
    Street address - Persian: میدان ابن سینا، دانشگاه علوم پزشکی فسا
    City - English: Fasa
    City - Persian: فسا
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7461686688
    Phone: +98 71 5335 0994
    Fax:
    Email: Research@fums.ac.ir
    Web page address:

Protocol summary

Study aim
The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer
Design
A randomized clinical trial,with 72 samples,was administered to control and test groups,randomized block,one blinded
Settings and conduct
At Amir Hospital oncology in Shiraz,with training sessions and presentation of pamphlets,Only research samples are unaware of the allocation of study groups
Participants/Inclusion and exclusion criteria
Women aged 25 to 75 with colon cancer who are at stage 1, 2 and 3؛ who are aware of their illness and have minimal religious beliefs. women who are reluctant to engage in research or have severe physical or psychological problems not allowed
Intervention groups
First , after a course of chemotherapy ,questionnaires will distributed.Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group. And for the control group Only a series of training modules(educational pamphlets) in connection with spirituality-based palliative care are considered.The interval between chemotherapy courses is usually two weeks And every patient needs ten to twelve weeks of chemotherapy.The training program(The curriculum) consists of 6 sessions ,that each session takes an average of 2 hours. Currently, this curriculum includes the following:first session: recitation of verses from Qur'an.second session: praying and discussing the psychological effects of praying.third session: Peer group discussions focused on relationship with God, Yourself ,others and nature.Fourth session: The Spiritual Authority 's Speech.fifth session: Play religious clips.sixth session: group praying.After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month
Main outcome variables
Pain score؛Quality of Life Score؛Nausea and Vomiting Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190106042252N1
Registration date: 2019-01-27, 1397/11/07
Registration timing: registered_while_recruiting

Last update: 2019-03-03, 1397/12/12
Update count: 1
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
parisa sabetsarvestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3784 4396
Email address
123ps74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-19, 1397/10/29
Expected recruitment end date
2019-02-02, 1397/11/13
Actual recruitment start date
2019-01-27, 1397/11/07
Actual recruitment end date
2019-02-16, 1397/11/27
Trial completion date
empty
Scientific title
The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer in Amir Shiraz Hospital
Public title
The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are at stage 1 and 2 and 3 of their illness Patients who are aware of their diagnosis Patients who have at least one chemotherapy course Patients at the minimum functional level Age between 25 and 75 years Complete mental health Willingness to cooperate Not suffering from other diseases except colon cancer Having minimal spiritual beliefs Lack of vision and hearing problems Lack of experience using palliative care base on spirituality
Exclusion criteria:
Lack of cooperation Occurs a particular physical condition
Age
From 25 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In the sampling method, all available patients Enter the study.These patiens are assigned to the test and control group by Block randomization. A: گروه کنترل B: گروه آزمون B(7) A(5) B(3) A(1) B(8) A(6) A(4) B(2) Then we randomize by Using 9 blocks of 8 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants are informed by informed consent and informed about the purpose of the study. However, they are not familiar with the control group or the test. Spirituality-based palliative care training sessions are held for the intervention group. In order to observe the intellectual property of the participants, the control group will be provided with a pediatric spirituality-based palliative care training package. All members are aware of the purpose of the study, and how they are done, but they are not informed about the two groups of control and test. So, the study is mono-blind, and researcher, clinical caregiver and data analyst are aware of the allocation of control and test groups. For Examples of mental health counselors, nutritionists, pain specialists, clerks, and final data analyst are known from the control and test team members, but participants do not know which groups will be included.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ebnesina square
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2018-11-11, 1397/08/20
Ethics committee reference number
IR.FUMS.REC.1397.095

Health conditions studied

1

Description of health condition studied
colon cancer
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified

Primary outcomes

1

Description
Pain score in Short Pain Questionnaire(BPI)
Timepoint
Measuring the pain before and after intervention and one month after the intervention
Method of measurement
Short Pain Questionnaire (Brief Pain Inventory)

2

Description
Quality of Life Score in World Health Organization Quality of Life Questionnaire
Timepoint
Measuring the quality of Life before and after intervention and one month after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire((WHOQOL-BREF)

3

Description
Nausea and vomiting score in the questionnaire for measurement of nausea and vomiting, Korn et al
Timepoint
Measuring the nausea and vomiting before and after intervention and one month after the intervention
Method of measurement
Questionnaire for measurement of nausea and vomiting by Korn et al (PUQE)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First , after a course of chemotherapy ,questionnaires will distributed between 36 member of the intervention group .Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group.The interval between chemotherapy courses is usually two weeks . And every patient needs ten to twelve weeks of chemotherapy , depending on the severity of the patient's disease and physician's discretion.The training program(The curriculum) consists of 7 sessions ,that each session takes an average of 1 hours. this curriculum includes the following: Session One: playing verses from the Holy Quran. Second Session: playing prayer and group chants. Session 3: Spiritual and peer-based Support,Talking to Patients about communication with God, your self, Others and Nature.Session Four: Playing Religious video Clips.Session 5: Spiritual Advice.Session Six: Nutrition Advice.Seventh Session: Mental Advice. After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month.
Category
Rehabilitation

2

Description
Control group: First, after completing a chemotherapy course, questionnaires are distributed among the control group members.Then, at the time of the referral of patients for the next chemotherapy course, these patients will receive only a series of educational pamphlets related to palliative care based on spirituality.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Parisa Sabet Sarvestani
Street address
Farhang shahr, Rajaei Blvd, Infront of Kowsar Water Park
City
Shiraz
Province
Fars
Postal code
7187915998
Phone
+98 71 3632 3532
Email
Amirhp@sums.ac.ir
Web page address
Https://amirhosp.sums.ac.ir/page-amirhp/fa/36/form/pId6915

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
DR. Mojtaba Farjam
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
Research@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Parisa Sabetsarvestani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.599, emam khomeini street, 22 alley
City
Sarvestan
Province
Fars
Postal code
7345187749
Phone
+98 71 3784 4396
Fax
Email
123ps74@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Parisa Sabetsarvestani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.599, emam khomeini street, 22 alley
City
Sarvestan
Province
Fars
Postal code
7345187749
Phone
+98 71 3784 4396
Fax
Email
123ps74@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Parisa Sabetsarvestani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.599, emam khomeini street, 22 alley
City
Sarvestan
Province
Fars
Postal code
7345187749
Phone
+98 71 3784 4396
Fax
Email
123ps74@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
No - There is not 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 data of the study is after statistical analysis and the results are comparable. Access to questionnaires and informed consent form is not permitted.
When the data will become available and for how long
2 months after the final release of the results
To whom data/document is available
Researchers working in academic and scientific institutions and hospital staff
Under which criteria data/document could be used
All clinics that are responsible for caring for patients with colon cancer can use this research to care for patients. It can also be used for other research on palliative care. The right to use the names of patients, the forms of consent to participate in the research.
From where data/document is obtainable
Parisa sabet sarvestani- 09171898537-123ps74@gmail.com Dr shahnaz karimi-09173310457-sh.karimi16@yahoo.com Fasa University of Medical Sciences- research@fums.ac.ir
What processes are involved for a request to access data/document
Search the title of research on valid sites calling the responsible person Email to Fasa University of Medical Sciences
Comments
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