NCT05057078

Brief Summary

Breast cancer ranks first among the cancers seen in women in the World. Due to breast cancer, patients experience spiritual distress. The aim of this study is to determine the effect of mindfulness-based stress reduction program applied to patients with breast cancer on spiritual well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 7, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

September 7, 2021

Last Update Submit

March 3, 2023

Conditions

Breast CancerNursing Caries

Keywords

Breast cancerSpiritualityNursing CareMindfulness

Outcome Measures

Primary Outcomes (2)

  • spiritual well-being-first

    The spiritual well-being level of the patients will be evaluated with FACIT-Sp scale

    immediately before the first session

  • spiritual well-being-last

    The spiritual well-being level of the patients will be evaluated with FACIT-Sp scale

    immediately after the last session

Secondary Outcomes (2)

  • Quality of life-first

    immediately before the first session

  • Quality of life-last

    immediately after the last session

Study Arms (2)

Intervention group

EXPERIMENTAL

A mindfulness-based stress reduction program will be done once a week for eight weeks

Behavioral: mindfulness-based stress reduction program

Control group

NO INTERVENTION

During study process, no application will be made to the control group.

Interventions

mindfulness-based stress reduction programBEHAVIORAL

groups of 10 people will be formed among the patients included in the mindfulness program group. A mindfulness-based stress reduction program will be done once a week for eight weeks and will take approximately 60-120 minutes. A plan will be made with the patients for the day and time of the session. During this process, no application will be made to the control group. Meetings will be held as an online session via Zoom Video Communications.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speaking and understanding Turkish,
  • to 65 year olds,
  • diagnosed at least 6 months ago,
  • Stage I, II or III breast cancer,
  • To be receiving outpatient treatment,
  • No barriers to joining online sessions.

You may not qualify if:

  • Having a diagnosed psychiatric illness or disorder,
  • End stage breast cancer,
  • Refusing to participate in the study,
  • Not participating regularly in the applied psycho-education program,
  • Making a psychiatric diagnosis after the research has started,
  • Initiation of inpatient treatment in the hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hatice ÖNER CENGİZ

Altındağ, Ankara, Turkey (Türkiye)

Location

İnönü university Turgut Ozal Medicine Central

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

  • Oner Cengiz H, Bayir B, Sayar S, Demirtas M. Effect of mindfulness-based therapy on spiritual well-being in breast cancer patients: a randomized controlled study. Support Care Cancer. 2023 Jul 3;31(7):438. doi: 10.1007/s00520-023-07904-2.

    PMID: 37395841DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hatice Öner Cengiz, PhD.

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 27, 2021

Study Start

September 29, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

TU(2)