Determining the effect of a care program based on the Roy adaptation model on fatigue in Elderly patients with cancer undergoing Chemotherapy
Design
A clinical trial with a control group, with parallel group design, without blindness, randomized through a random numbers table
Settings and conduct
This study was conducted in the oncology ward of three Hospitals of imam hossein, shohadaeh tajrish a taleghani in Tehran. Using the available sampling method, individuals were selected and randomly assigned to intervention and control groups. The samples of both groups completed Multidimensional Fatigue Inventory-20. For the intervention group, training sessions were conducted in six sessions. The post-test was taken one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in research and having cooperation; Minimum age of 65 and a maximum age of 80 years old; Do not have a history of cognitive impairment. Non Inclusion criteria: participation in the previous same care program in Last three months
Intervention groups
Intervention group: For the intervention group, an educational program is implemented including 1. Determining maladaptive behaviors in four physiological dimensions, self-understanding, role play, independence and dependence 2. Need help during problems 3. Identify measures to help to solve problems through nursing diagnoses 4. Identify possible barriers to the care plan 5. Set up an app for the elderly and follow up on the phone. In the intervention group, there are 6 60-minute training sessions (two sessions a week) will be performed. Control group: The control group receives routine care.
Main outcome variables
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190512043563N1
Registration date:2019-05-22, 1398/03/01
Registration timing:retrospective
Last update:2019-05-22, 1398/03/01
Update count:0
Registration date
2019-05-22, 1398/03/01
Registrant information
Name
Mozhgan Hajalimohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8355 3970
Email address
mozhgan.nurse.beheshti@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-09-16, 1397/06/25
Actual recruitment start date
2018-04-19, 1397/01/30
Actual recruitment end date
2018-09-16, 1397/06/25
Trial completion date
2018-09-16, 1397/06/25
Scientific title
The effect of a care program based on the Roy adaptation model on fatigue in Elderly patients with cancer undergoing Chemotherapy
Public title
The effect of a care program based on the Roy adaptation model on fatigue in Elderly patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in research and having cooperation
Ability to communicate effectively with the researcher
Ability to handle meetings and prepared to respond to questions physically and mentally
Minimum 65 and a maximum of 80 years old
Do not have a history of cognitive impairment
Exclusion criteria:
participation in previous same care program in Last three months
Age
From 65 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Actual sample size reached:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method was used for randomization.
Firstly, all eligible patients were selected based on the criteria of entry and assigned a special code. Then, according to the sample size and the same number, the coin was thrown, and the heads subjects in the intervention group and the tails subjects in the control group.
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 Shahid beheshti University of Medical Sciences
Street address
in front of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.SBMU.PHNM.1396.970
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
c18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
fatigue
Timepoint
Before and one month after intervention
Method of measurement
Multidimensional Fatigue Inventory-20
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, an educational program is implemented including 1.Determining Maladaptive behaviors in four physiological dimensions, self-understanding, role play, independence and dependence 2. Need help during problems 3. Identify measures to help solving problems through nursing diagnoses 4. Identify possible barriers to the care plan 5. Set up an app for the elderly and follow up on the phone. In intervention group, there are 6 60-minute training sessions (two sessions a week) will be performed. Control group.