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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Brief Self-compassion Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kübra DAKDEVİR

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Çankırı Karatekin University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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