NCT06707337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

November 24, 2024

Last Update Submit

February 19, 2025

Conditions

Keywords

CancerSelf-CompassionSelf-careColorectal CancerRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Self-Compassion Scale

    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)

    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)

Study Arms (2)

Participant Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

There will be no training or intervention.

Interventions

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.

Participant Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients with colorectal cancer in the experimental and control groups will be masked.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was planned as a prospective, two-armed (1:1), randomized controlled experimental study. This randomized controlled trial will be reported according to the CONSORT guidelines.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

November 24, 2024

First Posted

November 27, 2024

Study Start

November 15, 2024

Primary Completion

February 15, 2025

Study Completion

February 15, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations