Clinical trial NCT05457309: Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients
Official title: Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients Based on Symptom Management Theory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Fungating Wound
Keywords: Breast cancer
Malignant fungating wounds
Symptom management
Wound care
Quality of life
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Wound Size at day 42
timeFrame: Baseline and day 42
Secondary outcomes:
measure: Change from Baseline in Wound symptoms at day 42
timeFrame: Baseline and day 42
measure: Change from Baseline in Quality of life in breast cancer patients at day 42
timeFrame: Baseline and day 42
measure: Change from Baseline in Social support at day 42
timeFrame: Baseline and day 42
measure: Change from Baseline in Anxiety at day 42
timeFrame: Baseline and day 42
measure: Change from Baseline in Depression at day 42
timeFrame: Baseline and day 42
measure: Change from Baseline in Stigma at day 42
timeFrame: Baseline and day 42
Other outcomes:
measure: Change from Baseline in Wound bleeding at day 42
timeFrame: Baseline and day 42
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen memorial hospital, Sun Yat-sen university
state: Guangdong
Study officials:
References: