The Effect of Nurse-Led Coaching Program on Self-Care Agency and Quality of Life in Reconstructed Breast Cancer Patients

NCT07355946 | Completed

• 1 other identifier: E-77082166-302.08.01-1195604
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical study is to examine the effects of a nurse-led coaching program on self-care agency in breast cancer patients who have undergone reconstruction. The secondary objective is to determine the opinions of patients who participated in the nurse-led coaching program for breast reconstruction surgery. Primary questions the study aims to answer are:

• Patients who meet the inclusion criteria will be informed of the study's purpose during their postoperative hospital stay, and their informed consent will be obtained. Patients who agree to participate will complete an Introductory Information Form, the Self-Care Agency Scale, and the EORTC QLQ-C30 and QLQ-BR-42 Quality of Life Scales.
• After completing the pre-test measurements, the researchers will randomly assign patients to either the control or intervention groups using a random number table.
• Patients in the intervention group will receive a routine debriefing on the day of discharge and a total of nine coaching sessions, scheduled weekly for the first 6 weeks and biweekly for the following 6 weeks. These sessions will be conducted via online meeting.
• Patients in the control group will receive a routine debriefing only on the day of discharge.
• Post-test measurements will be administered to both groups at 12 weeks post-operatively.

Conditions

Breast Reconstruction

Keywords

nursing; coaching; quality of life; self-care agency; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Self-care Agency Scale

  The Self-Care Agency Scale is a five-point Likert-type scale developed after the concept of self-care was introduced. The scale was developed by Kearney and Fleischer in 1979, and the first version consisted of 43 items (Kearney \& Fleischer, 1979). The Turkish version, whose validity and reliability study was conducted by Nahcivan in 1993, was revised to 35 items. Each statement on the scale is scored 0, 1, 2, 3, and 4, respectively. "Describes me very much" receives 4 points, "Describes me very much" receives 3 points, "I have no idea" receives 2 points, "Does not describe me at all" receives 1 point, and "Does not describe me at all" receives 0 points. Eight of the statements (3, 6, 9, 13, 19, 22, 26, and 31) are evaluated negatively, and the scoring is reversed. The highest possible score on the scale is 140, representing the highest degree of self-care agency. In the Nahcivan study, Cronbach's alpha was determined to be 0.89.

  From enrollment to the end of coaching program at 12 weeks

Secondary Outcomes (1)

• EORTC QLQ-C30 Quality of Life Scale

  From enrollment to the end of coaching program at 12 weeks

Other Outcomes (2)

• EORTC QLQ-BR-42 Quality of Life Scale

  From enrollment to the end of coaching program at 12 weeks

• Program Effectiveness Evaluation Form

  At the end of the 12-week coaching program

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

EXPERIMENTAL

A total of 9 sessions of nurse-led coaching program are implemented for the intervention group over 12 weeks.

Behavioral: Nurse-led Coaching Program

Interventions

Nurse-led Coaching Program BEHAVIORAL

This intervention is implemented to increase patients' quality of life and self-care agency.

Intervention Group

Eligibility Criteria

• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having undergone breast reconstruction surgery due to breast cancer,
• Being 18 years of age or older,
• Being able to understand and speak Turkish,
• Voluntarily agreeing to participate in the study,
• Being able to read and write.

You may not qualify if:

• Having a speech, hearing, or vision impairment,
• Having a psychiatric diagnosis or ongoing treatment,
• Having metastatic breast cancer,
• Having a cancer diagnosis other than breast cancer.

Sponsors & Collaborators

• Gazi University: lead
• Kırıkkale University: collaborator

Study Sites (1)

Gazi University Health, Research and Application Center

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data obtained from the intervention and control groups were coded as group one and group two in the SPSS program. During the statistical analysis of the data in the study, the intervention and control group data were masked, and the statistical analyses were performed by a different expert to ensure the statistician's blindness. The statistician had no information about which group the patients belonged to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 21, 2026
• Study Start: February 24, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 2 years after the publication of results
• Access Criteria: They will be able to access via e-mail to sevil.guler@gazi.edu.tr and nihalyildizemre@kku.edu.tr.

Locations

TU (1)