Reducing mental stress, improving quality of life and increasing life expectancy in cancer patients
Design
The clinical trial has an intervention group and a control group, randomized and not blind
Settings and conduct
The aim of this study is to investigate the effect of group therapy based on acceptance and commitment on the death anxiety in cancer patients at the palliative medicine clinic of Torbat Heydarieh University of Medical Sciences.In this way that 20 patients with cancer are randomly assigned to intervention and control group.The intervention group will receive 10 sessions of group therapy based on acceptance and commitment weekly in a two-hour session, the control group will not receive any intervention.
Participants/Inclusion and exclusion criteria
Age of 18 to 60 years, having a case of cancer, not taking medication or other psychotherapy, not having a particular mental or physical illness
Intervention groups
Intervention group: Patients in the intervention group will participate in 10 sessions of group therapy based on acceptance and commitment in the form of weekly in a two-hour session, the control group will not receive any intervention.
Main outcome variables
Reducing death anxiety of cancer patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181009041282N1
Registration date:2018-10-31, 1397/08/09
Registration timing:prospective
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Maliheh Eshaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 6011
Email address
eshaghzadehm2@thums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group therapy based on Acceptance and Commitment on death anxiety of cancer patients with low income level
Public title
The effectiveness of group therapy based on Acceptance and Commitment on cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a case of cancer
Not having psychiatric, visual and auditory disorders
Not using psychotherapy and drug change outside of research intervention
The absence of a history of neuropsychological illness
The absence of heart, lung, kidney and liver disease
Exclusion criteria:
Admission in hospital during research
Missing more than three sessions
Having a history of drug abuse
Unwillingness to continue cooperation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
At first, 20 patients were selected through simple random sampling and then assigned to intervention and control groups using random block split and Randomization.com.
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 Torbat Heydarieh University of Medical Sciences
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Approval date
2018-07-06, 1397/04/15
Ethics committee reference number
IR.THUMS.REC.1397.019
Health conditions studied
1
Description of health condition studied
Death Anxiety
ICD-10 code
F41.8
ICD-10 code description
Other specified anxiety disorders
Primary outcomes
1
Description
Death Anxiety: A kind of panic or anxiety when thinking about the process of dying or disconnecting from the world or what happens after death.
Timepoint
The beginning of the study and after the intervention
Method of measurement
Templer death anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group will participate in 10 sessions of group therapy based on acceptance and commitment in the form of weekly in a two-hour session.
Category
Behavior
2
Description
Control group: The control group will not receive intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Palliative medicine Clinic of Torbat Heydarieh University of Medical Sciences
Full name of responsible person
Samaneh Eshaghzadeh
Street address
Qareh ney street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
PR@thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hasan Azhdari Zarmehri
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6114
Email
azhdarih1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Samaneh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
s.eshaghzadeh0@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Maliheh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
m.eshaghzadeh93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Maliheh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
m.eshaghzadeh93@gmail.com
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