- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06707337
Brief Self-Compassion Program in Colorectal Cancer
February 19, 2025 updated by: Kübra DAKDEVİR
The Effects of a Brief Self-compassion Program Applied to Patients with Colorectal Cancer on Self-compassion and Self-care
In this study, between 1 December 2024-31 March 2025, who met the inclusion and exclusion criteria, a total of 66 patients with colorectal cancer at the Etlik City Hospital General Surgery Department.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Brief Self-compassion Program will be held in a face-to-face hospital environment for the patients with colorectal cancer in the experimental group.
This training program has been developed based on the concepts of Mindfulness-Based Compassionate Living and Mindfulness-Based Stress Reduction Programs.
The content and topics of the sessions in the program are arranged according to the conceptual structure and flow of the mindfulness-based model.
The training program was created in a certain flow, based on the introduction to a short self-compassion program (1 sessions), the importance of self-compassion and self-care in the cancer experience (1 sessions), a self-compassionate approach to challenging emotions and situations (1 sessions).
There are 3 sessions in the program and the frequency of sessions is 3 times a week, and each session lasts approximately 45 minutes.
The training program will be applied to 33 patients with colorectal cancer in the experimental group.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey, 06170
- Ankara Etlik City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years of age and older
- Can speak and understand Turkish
- Has written permission
- Being hospitalized in the General Surgery Clinic of the relevant institution on the dates of the study
- Diagnosed with colorectal cancer
- Having no mental illness that would prevent participation in the study
Exclusion Criteria:
- Not knowing the diagnosis
- Receiving or having received any psychosocial support or training
- Having previously participated in programs related to self-compassion
- Being meditating
- Having any history of mental retardation or organic brain damage that would prevent participation in the training
- Having a problem with understanding and following the given instructions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participant Group
Brief Self-compassion Program will be held in a face-to-face hospital environment for the patients with colorectal cancer in the experimental group.
This training program has been developed based on the concepts of Mindfulness-Based Compassionate Living and Mindfulness-Based Stress Reduction Programs.
The content and topics of the sessions in the program are arranged according to the conceptual structure and flow of the mindfulness-based model.
The training program was created in a certain flow, based on the introduction to a short self-compassion program (1 sessions), the importance of self-compassion and self-care in the cancer experience (1 sessions), a self-compassionate approach to challenging emotions and situations (1 sessions).
There are 3 sessions in the program and the frequency of sessions is 3 times a week, and each session lasts approximately 45 minutes.
The training program will be applied to 33 patients with colorectal cancer in the experimental group.
|
Brief Self-compassion Program will be held in a face-to-face hospital environment for the patients with colorectal cancer in the experimental group.
This training program has been developed based on the concepts of Mindfulness-Based Compassionate Living and Mindfulness-Based Stress Reduction Programs.
The content and topics of the sessions in the program are arranged according to the conceptual structure and flow of the mindfulness-based model.
The training program was created in a certain flow, based on the introduction to a short self-compassion program (1 sessions), the importance of self-compassion and self-care in the cancer experience (1 sessions), a self-compassionate approach to challenging emotions and situations (1 sessions).
There are 3 sessions in the program and the frequency of sessions is 3 times a week, and each session lasts approximately 45 minutes.
The training program will be applied to 33 patients with colorectal cancer in the experimental group.
|
|
No Intervention: Control Group
There will be no training or intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion Scale
Time Frame: Change from before implementation, after practice is completed (1th week)
|
In order to determine the self-compassion levels of the patients participating in the study, the Self-Compassion Scale, which was developed by Neff (2003) (Neff, 2003) and adapted to Turkish by Akın, Akın and Abacı (2007) (Akın et al., 2007), was used.
The English form of the Self-Compassion Scale consists of 26 items and 6 subscales.
These subscales are self-compassion, isolation, awareness of sharing, self-judgment, over-identification and mindfulness.
The self-kindness sub-dimension includes items 2, 6, 13, 17, 21, the self-judgment sub-dimension includes items 4, 7, 15, 20, 26, the awareness of sharing sub-dimension includes items 1, 8, 12, 22, the isolation sub-dimension includes items 5, 11, 19, 25, the conscious awareness sub-dimension includes items 9, 14, 18, 23, and the over-identification sub-dimension includes items 3, 10, 16, 24.
The scale is a 5-point Likert-type scale with the ratings "1 Never", "2 Rarely", "3 Often", "4 Usually", "5 Always".
The factor loadings in all
|
Change from before implementation, after practice is completed (1th week)
|
|
Mindful Self-Care Scale (MSCS)
Time Frame: Change from before implementation, after practice is completed (1th week)
|
The scale, developed by Cook-Cottone and Guyker in 2018, consists of 33 items covering self-care behaviors (Cook-Cottone and Guyker, 2018).
The scale consists of 5-point Likert-type questions and only the 6th item is reverse coded.
The sub-dimensions of the scale consist of physical care, supportive relationships, conscious awareness, self-compassion and purpose, conscious relaxation, and supportive structure.
As the scores obtained from the scale increase, it is seen that the individual's self-care skills are high.
The internal consistency coefficient of the scale was found to be 0.89 overall, 0.69 for physical care, 0.86 for supportive relationships, 0.92 for awareness, 0.83 for self-compassion and purpose, 0.77 for conscious relaxation, and 0.77 for the supportive structure subscales.
The scale was adapted to Turkish by Aydın Sünbül and colleagues in 2018 (Aydın Sünbül et al., 2018).
After adaptation to Turkish, the scale maintained its subdimensions, while the internal consistency
|
Change from before implementation, after practice is completed (1th week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2024
Primary Completion (Actual)
February 15, 2025
Study Completion (Actual)
February 15, 2025
Study Registration Dates
First Submitted
November 24, 2024
First Submitted That Met QC Criteria
November 24, 2024
First Posted (Actual)
November 27, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 19, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ankara Etlik Şehir Hastanesi
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Thomas...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...CompletedColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on Brief Self-compassion Program
-
Hong Kong Metropolitan UniversityNot yet recruiting
-
Fatima NoorFatima Jinnah Women UniversityCompleted
-
University of BeykentNot yet recruiting
-
Neslihan LokCompletedStress | Burden, Caregiver | Care Givers | Satisfaction With LifeTurkey
-
Children's Hospital of Eastern OntarioJuvenile Diabetes Research Foundation; Brain CanadaCompleted
-
Nevsehir Haci Bektas Veli UniversityNot yet recruiting
-
Ordu UniversityEnrolling by invitation
-
University of ManitobaUnknown
-
University of California, BerkeleyCompletedTransdiagnostic PsychopathologyUnited States
-
The Miriam HospitalCompleted