Determining the effect of Self-care video education on quality of life and anxiety in patients with upper gastrointestinal cancer undergoing chemotherapy
Design
Clinical trials with intervention group and control group, parallel groups without blindness, randomized
Settings and conduct
The research environment of this study is the chemotherapy clinics of Shariati Hospital and the Institute cancer of Imam Khomeini Hospital. In this way, the samples are randomly assigned to the intervention and control groups using random numbers table from both hospitals.After performing the sampling and completing the QLQc30 quality of life questionnaire and the Spielberger's anxiety questionnaire, the educational film intervention group and the booklet control group are provided for viewing at home. Then, anxiety questionnaire is completed weekly for 3 months and the quality of life questionnaire is completed 3 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 18 years old
Having cancer of upper gastrointestinal tract, according to a doctor's diagnosis
Having experience at least one chemotherapy session
Having a device to watch educational video
Having the ability to read and write
Full knowledge and understanding in Farsi
Possibility to make phone calls and contacts with the patient
Exclusion criteria:
There is a diagnosis of psychological illness
Use of anxiolytic drugs
Vision and hearing problems
Intervention groups
The intervention group: includes 33 patient , educational film whose content includes: explanation of the disease, chemotherapy and its complications, and strategies for coping with illness and chemotherapy, relaxation techniques for reducing anxiety, to see them at home It will be given .
Control group: Includes 33 patients, who are given a booklet.
Main outcome variables
Quality of Life
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181115041669N1
Registration date:2019-03-10, 1397/12/19
Registration timing:prospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
shima kohansal
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3448 1541
Email address
shimakohansal@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self care video education on quality of life and anxiety in Upper gastrointestinal cancer patients undergoing chemotherapy
Public title
The effect of self care video education on quality of life and anxiety in Upper gastrointestinal cancer patients undergoing chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Having cancer of upper gastrointestinal tract, according to a doctor's diagnosis
Having experience at least one chemotherapy session
Having a device to watch educational video
Having the ability to read and write
Full knowledge and understanding in Farsi
Possibility to make phone calls and contacts with the patient
Exclusion criteria:
There is a diagnosis of psychological illness
Use of anxiolytic drugs
Vision and hearing problems lead to a lack of understanding educational content
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples were selected by available sampling method and then randomly divided into control and experimental groups using a random number table.
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
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor., Central Organization of the University., Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.TUMS.FNM.REC.1397.167
Health conditions studied
1
Description of health condition studied
esophageal cancer
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of oesophagus
2
Description of health condition studied
gastric cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Quality of life
Timepoint
Measuring quality of life at baseline (pre-intervention) and 3 months after the start of education
Method of measurement
QLQ-C30 quality of life questionnaire
2
Description
Anxiety
Timepoint
Measurement of anxiety at the beginning of the study (before the intervention) and weekly for 3 months after intervention
Method of measurement
Spileburge's State Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group of educational films consists of animated slides with sound that include: description of the disease, chemotherapy and its complications, and strategies for coping with complications during illness and chemotherapy, relaxation techniques for reducing anxiety, this People are given a home for viewing.
Category
Rehabilitation
2
Description
Control group: This booklet is given to the group, as well as the educational content of the film, for viewing at home.