CompletedNot Applicable

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

Turkey (Türkiye)58 participantsStarted 2025-02-24

Plain-language summary

The primary objective of this clinical study is to examine the effects of a nurse-led coaching program on self-care agency and quality of life in patients who have undergone reconstructive surgery for breast cancer. 1. Is there a difference in self-care agency between breast reconstructive patients who received a nurse-led coaching program and those who did not? 2. Is there a difference in quality of life between breast reconstructive patients who received a nurse-led coaching program and those who did not? The secondary objective of this clinical study is to determine the satisfaction levels of patients who participated in a nurse-led coaching program for breast reconstructive surgery. The secondary questions the study aims to answer are: 3. What is the satisfaction level of breast reconstructive patients who received a nurse-led coaching program? The researchers will compare whether there are differences in self-care agency and quality of life between breast cancer patients who received a nurse-led coaching program (intervention group) and those who did not (control group). Participants: * 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Self-care Agency Scale

Timeframe: From enrollment to the end of coaching program at 12 weeks

Trial details

NCT IDNCT07355946

SponsorGazi University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Breast Reconstruction trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.