NCT05240937

Brief Summary

Most women don't want to hear the word cancer, so they feel anxious and stressed. However, "cancer" can be the beginning of learning how to fight and being hopeful. Ontological well-being is a concept that includes the life project of the individual and the meaning of life. the life of the individual; It is a project that includes the past tense, present tense and future tense components. Mindfulness-based practices are an application that examines the psychological and physiological aspects of stress and includes the concept of self-compassion. Self-compassion requires a balanced approach to one's negative emotions. When studies with breast cancer patients are examined, it is emphasized that self-compassion has an effect on concepts such as quality of life, anxiety, depression, and body image. This research was planned to determine the effectiveness of the awareness-based self-compassion program applied to patients with breast cancer on the ontological well-being of individuals.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable breast-cancer

Status
unknown

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

First Submitted

Initial submission to the registry

February 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

February 4, 2022

Last Update Submit

April 12, 2022

Conditions

Keywords

MindfulnessSelf Compassionontological well-being

Outcome Measures

Primary Outcomes (1)

  • Ontological Well Being Scale

    Ontological Well-Being (OWB) is a concept introduced by Şimşek (2009) as a new approach to the Subjective Well-Being (SWB) perspective that exists in the fields of history, philosophy and psychology. The Ontological Well-Being Scale (OWBS), developed by Şimşek (2009) in accordance with this perspective, yielded significant results in positive and negative mental health areas, and was found to be related to the concepts of internal motivation and psychological well-being. The scale, which is grouped as "Past", "Now" and "Future", includes a total of 24 question items. The scale has four sub-dimensions: "nothingness" (meaninglessness), "activation" (activity), "regret" (regret) and "hope" (hope). The scale filled out based on my self-evaluation method was evaluated on a five-point scale; Participants are expected to mark an answer between "I don't feel at all" (1 point) and "I feel very intensely" (5 points) for each question.

    8 Months

Secondary Outcomes (1)

  • Beck Depression Scale

    8 Months

Study Arms (2)

mindfulness-based self-compassion will be applied

EXPERIMENTAL

The group in which mindfulness-based self-compassion program will be implemented.

Behavioral: mindfulness-based self-compassion will be applied

Control Group

NO INTERVENTION

The group in which mindfulness-based self-compassion program will not be implemented

Interventions

A mindfulness-based self-compassion program will be applied to this group of patients who have had breast cancer and have fully completed their treatment.

mindfulness-based self-compassion will be applied

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince the incidence of breast cancer in women is very high, the study will be conducted for women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being diagnosed with breast cancer
  • Being in the control process that has completed the treatment process
  • Having a score of 0-25 on the Beck Depression Scale
  • Not having a psychiatric diagnosis and no treatment
  • be between the ages of 30-55
  • Being a literate writer
  • Being able to use the internet and social media easily

You may not qualify if:

  • be in treatment
  • Having a score above 25 on the Beck Depression Scale
  • Having a psychiatric diagnosis and history
  • to be illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Behice Belkıs Çalışkan, PhD

CONTACT

Fatma Yasemin Kutlu, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 15, 2022

Study Start

May 15, 2022

Primary Completion

July 15, 2022

Study Completion

November 15, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share