Developing of Acceptance and Commitment Therapy (ACT) protocol based on psychological problems in people with prostate cancer and its effectiveness on health-related quality of life and psychological distress of them.
If the research hypotheses are proven, Acceptance and Commitment therapy (ACT) can be used in treatment centers to help treat patients with prostate cancer and have a significant role in improving the quality of life associated with the health and psychological distress of these patients.
Design
Controlled clinical trial, not blind, randomized design
Settings and conduct
At the Labafi Nejad Hospital, patients' files are reviewed and interviewed in the presence of the Dr. Mofid. If satisfied, patients complete the questionnaires in the pre-test and post-test stages.The treatment protocol is performed in 8 sessions on the intervention group at the Dr. Clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 50 and 75 years; Diagnosed prostate cancer in patients who completed standard therapies; Exclusion criteria: Mental disorders and other cancers.
Intervention groups
The ACT Therapy protocol will be administered to the experimental group to improve health-related quality of life and reduce psychological distress in patients with prostate cancer, and the control group will continue their treatment.
Main outcome variables
The main implications of this study are: psychological problems as measured by the DASS-21 scale; Quality of life is dependent on health as measured by the questionnaire (SF 36). The main consequences are pre-test and post-test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200209046424N1
Registration date:2020-03-14, 1398/12/24
Registration timing:registered_while_recruiting
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Fatemeh Baniasadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4471 9445
Email address
f.baniasadi@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-01, 1398/10/11
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing of Acceptance and Commitment Therapy (ACT) protocol based on psychological problems in people with prostate cancer and its effectiveness on health-related quality of life and psychological distress of them.
Public title
The Effect of Acceptance and Commitment Therapy on prostate cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the research project
Age 75 - 50 years
Minimum literacy
At least one year under treatment (with expert approval)
No addiction to any drug
Completion of consent to participate in the research
Low score of health related quality of life questionnaire and psychological problems scale
Exclusion criteria:
Kidney and liver diseases
Use of psychoactive drugs
Age
From 50 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the inclusion criteria and a pre-test session, 40 men who scored lower than average after completing the Depression, Anxiety and Stress Questionnaire (DASS 21) had health-related quality of life (SF 36).
Since the study groups have equal sample size, we use simple random allocation law which is one of the limited randomization methods and we divide people into two groups of intervention and control. Keep notes of patients on 40 separate sheets and place the sheets inside the draw container and then we randomly record the 20 sheets out of the container into the intervention group and place the remaining 20 sheets in the control group. If there is a loss in treatment sessions, the sample size will be randomly eliminated in order to equalize the sample size and eventually the number of subjects in both groups should be the same.
The experimental group (n=20) will have 8 sessions of 120-minute Acceptance and Commitment therapy and the control group will receive no intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shahid Chamran Blvd., Hormozgan University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.341
Health conditions studied
1
Description of health condition studied
Prostate Cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
Primary outcomes
1
Description
Psychological Problem Score on the Short Form of Depression, Anxiety and Stress Scale (DASS 21); Physical and Mental Health Score in Health Related Quality of Life Questionnaire (SF 36)
Timepoint
At the beginning of the study (before the intervention) and after 8 sessions of acceptance and commitment group therapy
Method of measurement
The Short Form of Depression, Anxiety and Stress Scale (DASS 21); Health Related Quality of Life Questionnaire (SF 36)
Secondary outcomes
1
Description
Health-related quality of life score and psychological problems score
Timepoint
Health-related Quality of Life Questionnaires (SF 36) and Depression, Anxiety and Stress Short Form (DASS 21) at baseline (before intervention) and after treatment protocol
Method of measurement
The Depression, Anxiety and Stress Questionnaire (DASS 21) Health-related quality of life (SF 36)
Intervention groups
1
Description
Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: Twenty patients have prostate cancer before the protocol is implemented In the pre-test, they completed the Short Form of Depression, Anxiety and Stress Questionnaire (DASS-21) and Health-Related Quality of Life (SF-36) with full specifications. In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks.
Category
Behavior
2
Description
Control group:Twenty patients with prostate cancer who complete the pre-test questionnaire of depression, anxiety and stress (DASS-21) and health-related quality of life (SF-36) with complete the specification. The group will receive routine care during this 4-week period and will not perform any additional work. After 4 weeks post-test this group will also complete the questionnaires.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Labafi Nejad Hospital, Dr. Mofid Office
Full name of responsible person
Dr. Bahman Mofid
Street address
9th Boulevard (Jaafari), Pasdaran st.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Email
mofid429@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Alireza Rosta
Street address
Sana'i Boulevard, Free Zone Organization Square, Islamic Azad University of Kish International Branch
City
kish Iland
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Fax
+98 76 4442 3957
Email
Info@IaukishInt.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Fatemeh Baniasadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4, Alley 16, Dehkade Olympic Blvd.
City
Tehran
Province
Tehran
Postal code
1489653143
Phone
+98 21 4471 9445
Email
f.baniasadi@iaukishint.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Poursharifi, Ph.D.
Position
Associate Professor of Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0045
Email
ha.poursharifi@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Baniasadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4, 16 Alley, Dehkadeh Olympic Blvd.
City
Tehran
Province
Tehran
Postal code
1489653143
Phone
+98 21 4471 9445
Email
f.baniasadi@iaukishint.ac.ir
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
Not applicable
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