Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients

NCT ID: NCT05457309

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-24
• Study Completion Date: 2024-07-30

Brief Summary

Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life.

Detailed Description

Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus, and there is an interrelationship between the symptoms. The symptoms presented by patients have certain individual differences and vary with the stage of treatment and treatment effect, which bring different degrees of distress to patients and their families and seriously affect patients' prognosis and quality of life. It is found that wound symptoms such as malodor are significantly negatively correlated with the quality of life of patients with malignant fungating wounds. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. With the continuous improvement of cancer treatment level, patients' quality of life is more representative of cure and recovery than survival to some extent. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will take the symptom management theory as the guide, start from the actual needs of patients and combine with the actual clinical situation to construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life and make their lives dignified and meaningful.

Conditions

Malignant Fungating Wound

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

malignant fungating wounds care regimen

malignant fungating wounds care regimen based on the evidences, expert consultation, pre-experiment and final determination

Group Type: EXPERIMENTAL

malignant fungating wounds care regimen

Intervention Type: PROCEDURE

1\) Preliminary construction of regimen: The researchers summarized the literatures and guidelines about malignant fungating wounds care, and then formed a preliminary draft of the regimen.2) Expert consultation: Experts in malignant fungating wound care, breast cancer and rehabilitation were consulted by email, and the researchers revised the protocol according to the experts' comments, and the final draft was determined after multiple rounds of consultation with experts. 3) Pre-experiment: The researchers investigated the enrolled patients to assess the feasibility of the protocol, and adjusted the content based on the feedback.4) Final Determining: including health records establishment, the intervention time, implementers, location, method and frequency. A wound care team was formed, interventions were carried out in terms of somatic care, wound home care, psychological support, and rehabilitation guidance, and the enrolled patients would be regularly followed by the researchers.

Interventions

malignant fungating wounds care regimen

1\) Preliminary construction of regimen: The researchers summarized the literatures and guidelines about malignant fungating wounds care, and then formed a preliminary draft of the regimen.2) Expert consultation: Experts in malignant fungating wound care, breast cancer and rehabilitation were consulted by email, and the researchers revised the protocol according to the experts' comments, and the final draft was determined after multiple rounds of consultation with experts. 3) Pre-experiment: The researchers investigated the enrolled patients to assess the feasibility of the protocol, and adjusted the content based on the feedback.4) Final Determining: including health records establishment, the intervention time, implementers, location, method and frequency. A wound care team was formed, interventions were carried out in terms of somatic care, wound home care, psychological support, and rehabilitation guidance, and the enrolled patients would be regularly followed by the researchers.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 18 years old with pathologically confirmed diagnosis of breast cancer.

• Tumor metastasis in the chest wall or other sites and rupture to form a malignant fungating wound with a wound area of at least 10cm2 or more.

• Knowing of the cancer diagnosis. ④ Capable and willing to receive follow-up.

• Informed consent and voluntary participation.

Exclusion Criteria

• Patients with mental illness or cognitive impairment and language expression deficiency.

• Patients with extensive metastasis of cancer throughout the body to the chest, shoulders, back, arms, etc. and whose treatment was ineffective.

• Patients at the end stage of death.

• Patients who refused to participate in this study.

Withdrawal criteria:

• Patients who developed serious complications during the study and were unable to continue the study.

• Patients who died during the study. ③Patients who requested withdrawal on their own during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen memorial hospital, Sun Yat-sen university

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

liangzhi Qiu, M.D.

Role: CONTACT

772029778@qq.com

+8615889962699

Facility Contacts

Liangzhi Qiu, M.D.

Role: primary

772029778@qq.com

8615889962699

Other Identifiers

SYSKY-2022-024-01

Identifier Type: -

Identifier Source: org_study_id