Effect of group motivational interviewing method versus feedback-oriented training method on fatigue and self-efficacy of patients with cancer undergoing chemotherapy: a randomized clinical trial
To assess the effect of group motivational interviewing method versus feedback-oriented training method on fatigue and self-efficacy of patients with cancer undergoing chemotherapy
Design
This is a randomized clinical trial with control group, phase III, in which 96 eligible patients with cancer undergoing chemotherapy will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Beheshti Hospital in Hamadan city on 96 eligible patients with cancer undergoing chemotherapy. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Having a cancer undergoing chemotherapy
Persian language
Ability to make phone calls
Information about his/her illness
Receiving at least three chemotherapy courses
Exclusion criteria:
Impaired consciousness or dementia
Mental disorder
Severe anemia
Malnutrition
Intervention groups
Intervention group 1:
Routine treatment plus a motivational interview for 45 to 60 minutes once a week for 5 weeks (including teaching and practicing the stages of change, brainstorming about the strengths and weaknesses of behavior and its relationship with fatigue and self-efficacy reduction, identifying and prioritizing values, providing recommendations to improve fatigue)
Intervention group 2:
Routine treatment plus feedback-oriented training for 45 to 60 minutes once a week for 5 weeks (including explanations about cancer and its common treatments, explaining the side effects of drugs, the effect of fatigue on life, improving nutritional status, improving sleep quality)
Control group:
Just routine treatment
Main outcome variables
Primary outcome:
Fatigue; self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N463
Registration date:2023-02-20, 1401/12/01
Registration timing:prospective
Last update:2023-02-20, 1401/12/01
Update count:0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group motivational interviewing method versus feedback-oriented training method on fatigue and self-efficacy of patients with cancer undergoing chemotherapy: a randomized clinical trial
Public title
Effect of group motivational interviewing method versus feedback-oriented training method on fatigue and self-efficacy of patients with cancer undergoing chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Having a cancer undergoing chemotherapy
Persian language
Ability to make phone calls
Information about his/her illness
Receiving at least three chemotherapy courses
Exclusion criteria:
Impaired consciousness or dementia
Mental disorder
Severe anemia
Malnutrition
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-02-05, 1401/11/16
Ethics committee reference number
IR.UMSHA.REC.1401.981
Health conditions studied
1
Description of health condition studied
Fatigue
ICD-10 code
R53.82
ICD-10 code description
Chronic fatigue, unspecified
Primary outcomes
1
Description
Fatigue
Timepoint
Before the intervention and 4 and 6 weeks later
Method of measurement
Using the Cancer Fatigue Scale (CFS)
2
Description
Self-efficacy
Timepoint
Before the intervention and 4 and 6 weeks later
Method of measurement
Using Chronic Disease Self-Efficacy Scale (CDSES)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Routine treatment plus a motivational interview for 45 to 60 minutes once a week for 5 weeks (including teaching and practicing the stages of change, brainstorming about the strengths and weaknesses of behavior and its relationship with fatigue and self-efficacy reduction, identifying and prioritizing values, providing recommendations to improve fatigue)
Category
Treatment - Other
2
Description
Intervention group 2:Routine treatment plus feedback-oriented training for 45 to 60 minutes once a week for 5 weeks (including explanations about cancer and its common treatments, explaining the side effects of drugs and specifically the complication of fatigue, the effect of fatigue on life, improving nutritional status, improving sleep quality, managing energy reserves)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan
Full name of responsible person
Zahra Rahmani Ini Olia
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
zahra.rahmani.iniolia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Rahmani Ini Olia
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahra.rahmani.iniolia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Morteza Shamsizadeh
Position
Master of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mortezashamsizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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