The purpose behind this study is to determine the effects of Self-Management on fatigue and depression in cancer patients undergoing chemotherapy. The study is a clinical trial in two groups of Intervention and Control. Self-Management 5 A’s program is includes 5 steps:Assess,Advise،Agree،Assis،Arrange . Intervention group is 5 sessions for each session to be between 60 to 90 minutes in 12weeks. And Control group enjoys only the usual cares. The main criteria for inclusion in the study include having the age of 18 to 70, being on the list of chemotherapy patients, and lack of known depression disorder. The main criteria for exclusion from the study are Lack of desire for continuing, and having depression score over 28 using Beck Questionnaire. Therefore, the total sample size in this study is 60 samples from which 30 patients are in Intervention group and 30 patients in Control group. Before the beginning of intervention, the questionnaire will be given to the samples. Then, at end of in the Intervention group, a quiz is taken from the samples and they are asked to complete Beck Depression Questionnaire and MFI Questionnaire;
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080829266N1
Registration date:2016-08-30, 1395/06/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-30, 1395/06/09
Registrant information
Name
Marjan Rozitalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7251
Email address
daman_nurses@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-08-31, 1395/06/10
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intervention Self-Management Model 5 A’s on severity fatigue and depression of cancer patients undergoing chemotherapy.
Public title
Effect of Self-Management on cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent for collaboration Having the age of 18 to 70 Being on the list of chemotherapy patients Having a minimum degree of literacy – Having acceptable listening and speaking abilities Lack of known depression disorder Exclusion criteria: Lack of desire for continuing Provided during the research for a new effective drug; new drugs be added to patients’ medications، Depression score over 28:
، using Beck Questionnaire Presence of acute complications arising from chemotherapy during the research Death of the patient depression score between13-28 ؛fatigue score between 20-100.
Exclusion criteria included: lack of patient motivation to continue intervention ؛ exacerbations leading to hospitalizations cancer patients in the hospital for the duration of the intervention؛migration and death.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Yasuj University of Medical Sciences
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7591994799
Approval date
2016-07-23, 1395/05/02
Ethics committee reference number
IR.YUMS.REC.1395-85
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
c76،c80
ICD-10 code description
Malignant neoplasms of ill-defined, secondary and unspecified sites
Primary outcomes
1
Description
Fatigue
Timepoint
Early intervention and immediately after the intervention.
Method of measurement
Multidimensional Fatigue Inventory
Secondary outcomes
1
Description
Depression
Timepoint
Early intervention and immediately after the intervention.
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
The control group received only routine care and not done any intervention by the researcher .
Category
Other
2
Description
The patients in self-management training , in time proportional with the convenience and patient request and in coordination with him, in 4 sessions self-management training, now taken 60-90 minutes.The training by the researcher ,2 sessions for face to face and 2 sessions for group training with a question and answer booklets will be The training by the researcher, for face to face training with a question and answer booklets with educational content include defining self-management , causes of disease, risk factors, symptoms, cancer self-management behaviors such as adherence diet, proper exercise, medication adherence, side effects will be teaching.researcher followed this group in 12 weeks with telephon and face to face weekly .Call time up to 15 minutes between the hours of 8 am to 8 pm and time to be determined in agreement with the patient. If you have questions or problems can be patient for 24 hours in contact with the researcher.In this type of track on a weekly basis about the patient's health status and health behaviors strengthen asked to adhere to treatment regimens and the need for referral is examined.on your daily monitoring available to researchers and the feedback he has received.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Motahhari clinic
Full name of responsible person
Nazafarin Hosini
Street address
Shiraz-NamaziSquare-Shiraz Motahhari clinic
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Yasuj University of Medical Sciences
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd.
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Nazafarin Hosini
Position
Community Health Nursing PhD - Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7433235141
Phone
+98 74 3323 5141
Fax
Email
hosseinichenar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Nazafarin Hosini
Position
Community Health Nursing PhD - Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
Email
hosseinichenar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Marjan Rozitalab
Position
MS student of Community Health Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
7591994799
Phone
+98 71 3839 2629
Fax
Email
daman_nurses@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)