The aim of this study is to investigate the effectiveness of mindfulness-based cancer Recovery training on Fatigue and Sleep Quality of cancer patients
Design
The study sample of this research will consist of 30 cancer patients, whose number is 350, purposefully selected from among all cancer patients and randomly divided into two groups of 15 people (control group of 15 people and experimental group of 15 people) ) will be assigned. The experimental group will be trained in the cancer healing program based on Carlson and Speka's mindfulness, which will be held once a week in 8 sessions of 90 minutes.To collect data, it is done from Akoyama fatigue questionnaire and The Pittsburgh Sleep Quality Questionnaire.
Settings and conduct
The current research is an experimental study with a pre-test-post-test design with a control group. The statistical population of this research included all cancer patients who were diagnosed with cancer in 1403 at the Shahid Rajaei Center of Babolsar city.
Participants/Inclusion and exclusion criteria
Non-participation in other courses of counseling and training, non-use of psychological drugs and consent to participate in this project, among the criteria for entry and absence of more than three sessions in therapy sessions, non-performance of homework and non-cooperation, among the criteria for exiting this research.
Intervention groups
The participants will be randomly divided into two experimental and control groups, and the experimental group will be trained in the cancer healing program based on mindfulness in 8 sessions of 90 minutes.
Main outcome variables
Improving fatigue and sleep quality of cancer patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240315061296N1
Registration date:2024-06-29, 1403/04/09
Registration timing:retrospective
Last update:2024-06-29, 1403/04/09
Update count:0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
sajjad Basharpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5622
Email address
basharpoor_sajjad@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-06-09, 1403/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Mindfulness-Based Cancer Recovery training on Fatigue and Sleep Quality of cancer patients
Public title
The effectiveness of Mindfulness-Based Cancer Recovery training on Fatigue and Sleep Quality of cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Failure to participate in other counseling and training courses
Not taking psychological drugs
Consent to participate in this plan
Exclusion criteria:
Absence of more than three sessions in treatment sessions
Not doing homework and not cooperating
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research ethics committees of university of mohaghegh ardebili
Street address
University of Mohaghegh Ardabili, the end of University Street, Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
1313156199
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.UMA.REC.1401.040
Health conditions studied
1
Description of health condition studied
breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Lung cancer
ICD-10 code
C34
ICD-10 code description
Malignant neoplasm of bronchus and lung
3
Description of health condition studied
ovarian cancer
ICD-10 code
C56
ICD-10 code description
Malignant neoplasm of ovary
4
Description of health condition studied
Prostate Cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Fatigue, Sleep Quality
Timepoint
Before the first session and after the eighth session
Method of measurement
the Akoyama Fatigue Questionnaire, The Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The present study was a quasi-experimental study with a pre-test, post-test design with a control group.The study sample of 30 people was selected through purposive sampling and randomly divided into two groups of 15 people (control group of 15 people and experimental group of 15 people). The experimental group was trained in Carlson and Speka's Mindfulness-Based Cancer Recovery, which was held in the form of 8 sessions of 90 minutes and held once a week.
Category
Lifestyle
2
Description
Control group: In the control group, 15 participants were randomly replaced. No intervention was done on this group during 8 sessions. Finally, a post-test was taken from this group as well as the intervention group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Babolsar Medical and Radiotherapy Center
Full name of responsible person
Sajjad Basharpoor
Street address
Shahid Rajaei Babolsar Medical and Radiotherapy Center, Beside fisheries, Shariati Street, Babolsar, Mazandaran province, Iran
City
Babolsar
Province
Mazandaran
Postal code
9987947419
Phone
+98 11 3528 9258
Email
rajaee@mubabol.ac.ir
Web page address
https://rajaee.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Sajjad Basharpoor
Street address
University of Mohaghegh Ardabili, the end of University Street, Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
1313156199
Phone
+98 45 3150 5000
Email
info@uma.ac.ir
Web page address
https://www.uma.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
20
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
Iranian academic center for education culture and research
Full name of responsible person
Sajjad Basharpoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Mohaghegh Ardabili, the end of University Street, Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
1313156199
Phone
+98 45 3150 5622
Email
basharpoor_sajjad@yahoo.com
Web page address
https://www.uma.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Sajjad Basharpoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Mohaghegh Ardabili, the end of University Street, Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
1313156199
Phone
+98 45 3150 5622
Email
nematpourdarzi76@gmail.com
Web page address
https://www.uma.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Sajjad Basharpoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Mohaghegh Ardabili, the end of University Street, Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
1313156199
Phone
+98 45 3150 5622
Email
basharpoor_sajjad@yahoo.com
Web page address
https://www.uma.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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