Evaluation of the Effectiveness of Mindfulness-based Cognitive Therapy on Quality of Life and Mood (anxiety and depression) in Women with Breast Cancer undergoing Mastectomy
Abstract
Introduction: The present research has been carried out to investigate the effectiveness of group mindfulness-based cognitive therapy on quality of life and mood (anxiety and depression) in women with breast cancer undergoing mastectomy.
Materials and Methods: This research is a quasi-experimental study (pretest-posttest with control). In this clinical trial, 50 voluntary patients who had undergone mastectomy in 2013 and 2014 were screened among the patients admitted to Omid Hospital and Reza Treatment Center in Mashhad, the Patients initially selected voluntarily and were randomly divided into experimental group (n=25) and control group (n=25). First, both groups were pretested. Then, the experimental group received group MBCT treatments during eight sessions of 120 minutes (one session per week), but the control group received no treatment. At the end of treatment, both groups received the post-test. Data collection tools included standard questionnaires temperament (POMS) and the quality of life questionnaire (SF-36). The main outcomes of present study were quality of life and mood.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017040933315N1
Registration date:2017-06-03, 1396/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-03, 1396/03/13
Registrant information
Name
Zahra Olyaie
Name of organization / entity
Science and Research Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 7900
Email address
olyaiez@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-06-19, 1392/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Mindfulness-based Cognitive Therapy on Quality of Life and Mood (anxiety and depression) in Women with Breast Cancer undergoing Mastectomy
Public title
Mindfulness-based Cognitive Therapy in Women with Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in research; Iranian nationality; age less than 70; passing at least primary school education.
Exclusion criteria: history of chronic diseases; mental disorders; presence of other cancers; using drugs or psychotropic substances during one week before the study; experiencing stressful events during the last 6 months; addiction to drugs
Age
To 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
At first, the patients received a form to fill out if they might want to fill it. Volunteers and purposive samples registered and were selected based on sampling and categorized randomly in two groups of testing and control
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Mashhad University of Medical Sciences
Street address
Qureshi Building, University Street, Mashhad
City
Mashhad
Postal code
91375 - 345
Approval date
2013-05-22, 1392/03/01
Ethics committee reference number
23420701912010
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
Quality of Life
Timepoint
Befor and After Intervention
Method of measurement
Quality of Life Questionnaire (SF-36)
2
Description
Mood
Timepoint
Befor and After Intervention
Method of measurement
Standard Questionnaires Temperament (POMS)
Secondary outcomes
1
Description
Anxiety
Timepoint
Befor and After Intervention
Method of measurement
Standard Questionnaires Temperament (POMS)
2
Description
Depression
Timepoint
Befor and After Intervention
Method of measurement
Standard Questionnaires Temperament (POMS)
Intervention groups
1
Description
Intervention group: patients in this group received group MBCT (group mindfulness-based cognitive therapy) during eight 120-minute sessions (one session per week).
Category
Other
2
Description
Control group: patients in this group received no treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Dr Sodabeh Shahid Sales
Street address
Omid Hospital, Koohsangi Avenue, Alandash Square.
City
Mashhad
2
Recruitment center
Name of recruitment center
Reza Treatment Center
Full name of responsible person
Dr Varshoee
Street address
Misaq 19, Misaq Blvd, Vakil abad Blvd.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for reseach of Neyshabor Islamic Azad University
Full name of responsible person
Dr Ahmad Zendehdel
Street address
Islamic Azad University, Pazhuhesh Street, Neyshbor, Khorasan Razavi
City
Neyshbor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for reseach of Neyshabor Islamic Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Reza Treatment Center
Full name of responsible person
Mrs Sabeti
Position
Management Research
Other areas of specialty/work
Street address
Misaq 19, Misaq Blvd, Vakil abad Blvd.
City
Mashhad
Postal code
Phone
+98 51 3522 4472
Fax
Email
sabetinu@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Science and Research Branch, Islamic Azad University, Tehran, Khorasan Razavi
Full name of responsible person
Zahra Olyaie
Position
MA in Clinical Psychology
Other areas of specialty/work
Street address
Science and Research Branch, Islamic Azad University, Pazhuhesh Street, Neishabur, Khorasan Razavy
City
Mashhad
Postal code
9319797139
Phone
+98 51 3768 7900
Fax
Email
Olyaiez@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Omid Hospital
Full name of responsible person
Dr Sodabeh Shahid Sales
Position
Oncology subspecialist, Assistant Professor
Other areas of specialty/work
Street address
Omid Hospital, Koohsangi Avenue, Alandash Square
City
Mashhad
Postal code
-
Phone
+98 51 3842 6082
Fax
-
Email
shahidsaless@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)