Determining the effectiveness of acceptance and commitment-based therapy on improvement in demoralization syndrome, cancer-related trauma, benefit finding and adherence to treatment in breast cancer patients and survivors
Determining the effectiveness of acceptance and commitment-based therapy on improvement in demoralization syndrome, cancer-related trauma, benefit finding and adherence to treatment in breast cancer patients and survivors
Design
Clinical trial with control group, with parallel, randomized groups, on 64 patients (4 groups of 16 people). Excel software rand function was used for randomization.
Settings and conduct
Kosar Hospital Semnan; and Semnan Koomesh Cancer Patients Support Association.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of cancer by an oncologist; At least three months have passed since the illness; At least 20 years old.
Exclusion criteria: Psychotic problems; Absence of more than two sessions of treatment sessions.
Intervention groups
Intervention group 1: This group includes breast cancer patients who are receiving treatment. According to the protocol, interviews based on acceptance and commitment therapy are conducted individually by the researcher for patients during 8 sessions (one 90-minute session per week).
Control group 1: Only for comparison with intervention group 1, no treatment is performed.
Intervention group 2: This group includes patients who have recovered from breast cancer. According to the protocol, interviews based on acceptance and commitment therapy are conducted individually by the researcher for patients during 8 sessions (one 90-minute session per week).
Control group 2: Only for comparison with intervention group 2, no treatment is performed.
Main outcome variables
Fear of cancer recurrence; Existential Anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N60
Registration date:2020-10-27, 1399/08/06
Registration timing:registered_while_recruiting
Last update:2020-10-27, 1399/08/06
Update count:0
Registration date
2020-10-27, 1399/08/06
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-23, 1399/04/03
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of acceptance and commitment-based therapy on improvement in demoralization syndrome, cancer-related trauma, benefit finding and adherence to treatment in breast cancer patients and survivors
Public title
Determining the effectiveness of acceptance and commitment-based therapy on improvement in demoralization syndrome, cancer-related trauma, benefit finding and adherence to treatment in breast cancer patients and survivors
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of cancer by an oncologist
At least three months have passed since the illness
At least 20 years old
Exclusion criteria:
Psychotic problems
Absence of more than two sessions of treatment sessions
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 4).
Using Excel software to generate random number tables
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.SEMUMS.REC.1399.089
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Fear of cancer recurrence
Timepoint
Before and after the intervention
Method of measurement
Questionnaire fear of cancer recurrence
2
Description
Existential Anxiety
Timepoint
Before and after the intervention
Method of measurement
Questionnaire fear of cancer recurrence
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group includes breast cancer patients who are receiving treatment. According to the protocol, interviews based on acceptance and commitment therapy are conducted individually by the researcher for patients during 8 sessions (one 90-minute session per week).
Category
Rehabilitation
2
Description
Control group 1: Only for comparison with intervention group 1, no treatment is performed.
Category
Lifestyle
3
Description
Intervention group 2: This group includes patients who have recovered from breast cancer. According to the protocol, interviews based on acceptance and commitment therapy are conducted individually by the researcher for patients during 8 sessions (one 90-minute session per week).
Category
Rehabilitation
4
Description
Control group 2: Only for comparison with intervention group 2, no treatment is performed.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Eshagh Rahimian
Street address
Amin Street
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Email
are20935@gmail.com
2
Recruitment center
Name of recruitment center
Semnan Koomesh Cancer Patients Support Association
Full name of responsible person
Eshagh Rahimian
Street address
Taleghani street
City
Semnan
Province
Semnan
Postal code
3519614175
Phone
+98 23 3333 2076
Email
info@es-semnan.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
Seyfollah Sadodin
Street address
Opposite the park Sokan
City
Semnan
Province
Semnan
Postal code
35131-19111
Phone
+98 23 3153 5859
Email
research@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University
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
Semnan University
Full name of responsible person
Eshagh Rahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Opposite Sokan Park
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Eshagh Rahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Opposite Sokan Park
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Eshagh Rahimian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Opposite Sokan Park
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@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