Protocol summary
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Study aim
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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
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Design
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A randomized clinical trial,with 72 samples,was administered to control and test groups,randomized block,one blinded
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Settings and conduct
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At Amir Hospital oncology in Shiraz,with training sessions and presentation of pamphlets,Only research samples are unaware of the allocation of study groups
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Pain score؛Quality of Life Score؛Nausea and Vomiting Score
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2019-01-27, 1397/11/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-19, 1397/10/29
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Expected recruitment end date
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2019-02-02, 1397/11/13
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Actual recruitment start date
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2019-01-27, 1397/11/07
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Actual recruitment end date
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2019-02-16, 1397/11/27
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Trial completion date
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empty
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Scientific title
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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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Public title
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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
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 75 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
72
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-11, 1397/08/20
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Ethics committee reference number
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IR.FUMS.REC.1397.095
Health conditions studied
1
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Description of health condition studied
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colon cancer
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ICD-10 code
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C18.9
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ICD-10 code description
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Malignant neoplasm of colon, unspecified
Primary outcomes
1
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Description
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Pain score in Short Pain Questionnaire(BPI)
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Timepoint
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Measuring the pain before and after intervention and one month after the intervention
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Method of measurement
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Short Pain Questionnaire (Brief Pain Inventory)
2
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Description
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Quality of Life Score in World Health Organization Quality of Life Questionnaire
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Timepoint
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Measuring the quality of Life before and after intervention and one month after the intervention
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Method of measurement
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World Health Organization Quality of Life Questionnaire((WHOQOL-BREF)
3
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Description
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Nausea and vomiting score in the questionnaire for measurement of nausea and vomiting, Korn et al
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Timepoint
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Measuring the nausea and vomiting before and after intervention and one month after the intervention
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Method of measurement
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Questionnaire for measurement of nausea and vomiting by Korn et al (PUQE)
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Fasa University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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2 months after the final release of the results
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To whom data/document is available
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Researchers working in academic and scientific institutions and hospital staff
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Parisa sabet sarvestani- 09171898537-123ps74@gmail.com
Dr shahnaz karimi-09173310457-sh.karimi16@yahoo.com
Fasa University of Medical Sciences- research@fums.ac.ir
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What processes are involved for a request to access data/document
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Search the title of research on valid sites
calling the responsible person
Email to Fasa University of Medical Sciences
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Comments
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