The effectiveness of mindfulness based stress reduction on self management strategies, fatigue, fear of cancer recurrence, and cognitive impairment in colorectal and breast cancer patients
Determining the effectiveness of mindfulness based stress reduction on fatigue, self management strategies, fear of cancer recurrence, and cognitive impairment in colorectal and breast cancer patients
Design
Clinical trial with control group, community based and pragmatic, randomized.
Settings and conduct
38 patients with colorectal and breast cancer were randomly assigned to control and intervention groups. Both groups were evaluated in the pretest using the scales (fatigue questionnaire, fear of cancer recurrence inventory, Wechsler memory scale revised، SAT(Smart Management Strategy for Health Assessment Tool) questionnaire), of the study. They also completed their personal consent form and the demographic questionnaire. Then the intervention group received the MBSR program for eight weeks in the rehabilitation College of Shiraz university of Medical Science. After completing the intervention, both groups were evaluated in the post test, and data were analyzed by using descriptive, multivariate and univariate covariance analysis statistics.
Participants/Inclusion and exclusion criteria
Infected with breast and colorectal cancer, and receive diagnosis by an oncologist
Not participating in a mindfulness based stress reduction program before the study.
Intervention groups
The intervention group receives a mindfulness based stress reduction program for eight weeks, but control group doesn't receive any intervention.
Main outcome variables
Fear of cancer recurrence, cancer related cognitive impairment, self management strategies, and fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180331039163N1
Registration date:2018-11-22, 1397/09/01
Registration timing:retrospective
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
Nasrin Ahmadiqaragezlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 3391
Email address
vojdanir@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-04-21, 1397/02/01
Trial completion date
2018-06-22, 1397/04/01
Scientific title
The effectiveness of mindfulness based stress reduction on self management strategies, fatigue, fear of cancer recurrence, and cognitive impairment in colorectal and breast cancer patients
Public title
The effectiveness of Mindfulness based stress reduction in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Getting a diagnosis of colorectal and breast cancer and approved by an oncologist
Patients who have completed treatment or still receiving treatment
Bing over 18 to 65 years of age
Exclusion criteria:
Having more than two absentee sessions
Participate in yoga classes and meditation before implementing the plan
Problem in hearing and speaking
Participating in the mindfulness based stress reduction program
Getting psychotherapy by a psychologist or psychiatric
Participate in other psychosocial programs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
One methods of randomization in studies is random blocking, in this way, the number of people assigned to each group is usually approximately the same. In this method, blocks are formed based on the desired variables, and within each block, half of the intervention and half as the control are considered.The main object of this method is to balance the number of participants in each group.
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
Ethics committee of Shiraz University of Medical Sciences
Street address
No. 52, West Hedayat Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
Ir.sum.rec.1396.192
Health conditions studied
1
Description of health condition studied
Colorectal cancer and breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cancer related fatigue
Timepoint
Pre test and post test
Method of measurement
Fatigue questionnaire
2
Description
Cancer related cognitive impairment
Timepoint
Pre and post test
Method of measurement
Wechsler memory scale-Revised
3
Description
Fear of cancer recurrence
Timepoint
Pre and post test
Method of measurement
Fear of cancer recurrence inventory
4
Description
Self management strategies
Timepoint
Pre and post test
Method of measurement
Smart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group receives mindfulness-based stress reduction(MBSR). This is an eight-week group training program, Whit a meeting held every week for two hours, in which patients experientially practice body scan, sitting media, mindful walking, hatta yoga, mindful eating.
Category
Behavior
2
Description
Control group doesn't receive any intervention. The group to the questionnaires in Pre test and post test.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir oncology hosputal
Full name of responsible person
Nasrin Ahmadiqaragezlou
Street address
No. 11, Shahid Rajaei Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3632 3731
Fax
+98 71 3632 5655
Email
amirhp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Motahari clinic
Full name of responsible person
Nasrin Ahmadiqaragezlou
Street address
Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Vojdani
Street address
Zand Stret, Central Department of Shiraz University of Medical Science
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
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
Shiraz University of Medical Sciences
Full name of responsible person
Reza Vojdani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Namazi Square, Shahid Motahari Clinic, Shiraz
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3612 1000
Email
vojdani@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Semnan
Full name of responsible person
Issac Rahimian Boogar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Semnan University
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3365 4100
Fax
+98 23 3332 1005
Email
I_rahimian@semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasrin Ahmadiqaragezlou
Position
Ph.D. Student of Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.30, Alley 31/2, Shahid Rajaei Blvd. Shiraz
City
Shiraz
Province
Fars
Postal code
7185954679
Phone
+98 71 3633 3091
Email
ahmadiqaragezlou@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Demographic data, methodical data, Dara analysis
When the data will become available and for how long
As the results are published
To whom data/document is available
Researchers, research centers, academic institutions, therapeutic centers for cancer patients
Under which criteria data/document could be used
Using the data to improve the psychological distress, fatigue, cognitive impairment, fear of cancer recurrence in cancer patients
From where data/document is obtainable
By sending email to the writers
What processes are involved for a request to access data/document