The Effectiveness of Group Compassion-Focused Therapy on Severity of Pain, Emotion regulation, Body image, Interpersonal stress and Quality of Life Among women with Breast Cancer
The Effectiveness of Group Compassion-Focused Therapy on Severity of Pain, Emotion regulation, Body image, Interpersonal stress and Quality of Life Among women with Breast Cancer
Design
In this study, which has a control group with parallel and single-blind groups, 44 patients with breast cancer will be randomly divided into two treatment groups based on compassion and control through the site www.randomizer.com.
Settings and conduct
Compassion-focused group therapy is used in 8 sessions of 90 minutes each week. Sampling and treatment will be performed in Beheshti and Yathrebi hospitals in Kashan and it is single-blind for the participants.
Participants/Inclusion and exclusion criteria
Inclusion: Having a diagnosis of breast cancer- Min age 18 and max 55 years-Having at least one recent course of chemotherapy, radiation therapy or mastectomy-The same phase of the disease in both groups-No other physical illnesses-Lack of mental disorders requiring immediate treatment- Having at least the fifth elementary education level- Not receiving psychological interventions during the last year stage.
Exclusion: Lack of satisfaction to participate in research- unwillingness to continue treatment-Absence from treatment for two sessions- Having a mental disorder that requires immediate treatment -Intense thinking about self-harm or suicide- Physical inability to perform exercises - Simultaneous participation in another treatment program-Having psychiatric side effects from medications such as tamoxifen and letrofem
Intervention groups
The intervention group will receive 8 sessions of compassionate therapy for two months, 90 minutes per week. The control group also benefits from conventional therapy (TAU).
Main outcome variables
Severity of pain , Emotion regulation, Body image, Interpersonal stress and Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220318054327N1
Registration date:2022-03-30, 1401/01/10
Registration timing:prospective
Last update:2022-03-30, 1401/01/10
Update count:0
Registration date
2022-03-30, 1401/01/10
Registrant information
Name
Nastaran Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4452 4558
Email address
nastaran1997mehrabi@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Group Compassion-Focused Therapy on Severity of Pain, Emotion regulation, Body image, Interpersonal stress and Quality of Life Among women with Breast Cancer
Public title
The Effectiveness of Group Compassion-Focused Therapy on Severity of Pain, Emotion regulation, Body image, Interpersonal stress and Quality of Life Among women with Breast Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of breast cancer by a cancer specialist
Minimum age 18 and maximum 55 years
Having at least one recent course of chemotherapy, radiation therapy or mastectomy
The same phase of the disease in patients of both groups
No other physical illnesses
Lack of mental disorders requiring immediate treatment such as substance and alcohol use disorders and psychotic disorders
Having at least the fifth elementary education level (having literacy to perform cognitive tasks)
Not receiving psychological interventions during the last year and related drug treatment at least one month before the baseline assessment stage until the end of the follow-up stage
Exclusion criteria:
Lack of motivation and satisfaction to participate in research
Unfortunate events occur for the person or her unwillingness to continue treatment
Absence from treatment for two sessions
Having a mental disorder that requires immediate treatment such as substance and alcohol use disorders and psychotic disorders
Intense thinking about self-harm or suicide
Physical inability to perform exercises (for example, having a lot of pain)
Simultaneous participation in another treatment program
Having psychiatric side effects from breast cancer-related medications such as tamoxifen and letrofem
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, according to the inclusion and exclusion criteria, 44 patients with breast cancer are purposefully selected. They will then be divided into two groups of 22 people with compassion-focused therapy (CFT) and control through random assignment using the Randomization Website at Psychological Experiments, Medical Trials, and Field Studies at www.randomizer.com. .
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after the participants are selected, they are randomly assigned to the intervention or control group without knowing that there are two groups in this study. We start the treatment, but the treatment that is applied to them will be explained. The blindness of the participants in the treatment is that they do not know that there is another group. But after the end, they find out about the existence of another group and if they want, the treatment will be done for them. The researcher is aware of the existence of the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Qutb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.214
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
Severity of Pain
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
McGill Pain Revised Questionnaire
2
Description
Emotion regulation
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Difficulty in emotion regulation scale
3
Description
Body image
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Body image scale
4
Description
Interpersonal stress
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Interpersonal Stress Questionnaire
5
Description
Quality of Life
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Quality of Life Questionnaire for Cancer Patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Compassion-Focused Therapy-Compassion-focused therapy is based on a neurological transformation approach to mental health problems and focuses on four areas: past experiences, underlying fears, security strategies, and unintended consequences. In compassion-focused therapy, people learn not to avoid or suppress their painful feelings, so they can learn from their experience and feel compassion for it.
Category
Behavior
2
Description
Control group: The control group means the group that does not receive any treatment other than its own medication.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hamid Amiri
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences, Qutb Ravandi Blvd.