Colorectal CancerNCT06707337
Brief Self-Compassion Program in Colorectal Cancer
A study testing Brief Self-compassion Program in people with Colorectal Cancer, run by Kübra DAKDEVİR at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Brief Self-compassion Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Brief Self-compassion Program
- Keywords
- Cancer, Self-Compassion, Self-care, Colorectal Cancer, Randomized Controlled Trial
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Self-compassion ProgramOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Brief Self-compassion Program |
| Control Group | No intervention | There will be no training or intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from before implementation, after practice is completed (1th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Nov 2024
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kübra DAKDEVİR
- Sponsor type
- Other government
- Collaborators
- Çankırı Karatekin University
- Responsible party
- Sponsor-investigator, Kübra DAKDEVİR, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707337
- Sponsor's protocol ID
- Ankara Etlik Şehir Hastanesi
- Status last verified
- Feb 2025
- First submitted
- 24 Nov 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Brief Self-compassion Program Applied to Patients With Colorectal Cancer on Self-compassion and Self-care
- ClinicalTrials.gov ID
- NCT06707337
- Acronym / sponsor ID
- Ankara Etlik Şehir Hastanesi
- Conditions
- Colorectal Cancer
- Keywords
- Cancer, Self-Compassion, Self-care, Colorectal Cancer, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kübra DAKDEVİROther government
- Collaborators
- Çankırı Karatekin University
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Other: Brief Self-compassion ProgramBrief 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. |
| Control Group | No intervention | –There will be no training or intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Self-compassion ProgramBrief 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 | Participant Group |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Self-compassion Program in people with Colorectal Cancer, run by Kübra DAKDEVİR at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Compassion Scale (time frame: Change from before implementation, after practice is completed (1th week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.