NCT05914415

Brief Summary

Breast cancer is one of the most common types of cancer today. Treatment is planned depending on various factors. The most common treatment option is surgery. Mastectomy is a type of surgery in which the entire breast is removed. Tumorous tissue is removed with mastectomy, and cancer is treated, but after the intervention, physiological, psychological and social problems may occur in individuals in the acute and chronic periods. By providing pre-operative education, complications in the postoperative period can be reduced and the patient's compliance with the treatment can be ensured. It is stated in the studies that the training given by the nurses with different methods before the surgery reduces the anxiety, pain level and increases the comfort of the patients. No study was found in which the preoperative structured education given to patients scheduled for mastectomy was evaluated with the Postoperative Healing Quality Scale. The study is planned to be conducted as a randomized controlled experimental study and the patients who applied to Bakırköy Dr.Sadi Konuk Training and Research Hospital General Surgery Clinic for mastectomy constitute the research population. The sample is planned to consist of 70 patients, including 35 control and 35 experimental groups. In the structured training program in the research, both face-to-face information will be given to the patients and a written training booklet will be used. Patient Diagnosis Form, Recovery Quality Scale will be used to collect data. Through the data obtained, it will be evaluated whether the education given to the patients who are planned for mastectomy has an effect on the quality of recovery in the early postoperative period. It is thought that this study will reveal the benefits of preoperative education, increase the health care satisfaction of the patients and support their recovery.

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 P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 22, 2023

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 26, 2022

Last Update Submit

June 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • quality of recovery rate

    The quality of recovery of patients given structured education

    6 months

Study Arms (2)

Control

PLACEBO COMPARATOR

standard preoperative training

Other: Supportive care and education before surgery

Experimental

EXPERIMENTAL

structured training app

Other: Supportive care and education before surgery

Interventions

we will give supportive and informative education before surgery in order to increase patient' recovery rates

ControlExperimental

Eligibility Criteria

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

You may qualify if:

  • Having a mastectomy operation
  • At least primary school graduate
  • No psychiatric illness
  • No communication problems
  • Willingness to participate in the research
  • Complete the data collection forms

You may not qualify if:

  • Existence of a situation that prevents communication
  • Unwillingness to participate in the research
  • Incomplete answers to the questionnaire
  • Individuals who are unwilling to continue the research will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

June 22, 2023

Study Start

July 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

June 22, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share