Malignant Fungating WoundNCT05457309
Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients
A study testing malignant fungating wounds care regimen in people with Malignant Fungating Wound, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Fungating Wound
- What is being tested?
- malignant fungating wounds care regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen memorial hospital, Sun Yat-sen university
Guangzhou, Guangdong, 510120
Liangzhi Qiu, M.D., 8615889962699, 772029778@qq.com
About this study
Official title: Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients Based on Symptom Management Theory
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.
Read the 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
- Being tested
- malignant fungating wounds care regimen
- Keywords
- Breast cancer, Malignant fungating wounds, Symptom management, Wound care, Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
malignant fungating wounds care regimenProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| malignant fungating wounds care regimen | Experimental | malignant fungating wounds care regimen based on the evidences, expert consultation, pre-experiment and final determination Receives: Procedure: malignant fungating wounds care regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Wound Size at day 42
described by "healing, improvement, maintenance, deterioration", where "wound healing" refers to 100% epithelialization of the wound, "wound improvement" refers to reduction of the wound area, "wound maintenance" refers to no change in the wound area, and "wound deterioration" refers to an increase in the wound area.
Measured: Baseline and day 42
Secondary outcomes (6)
Change from Baseline in Wound symptoms at day 42
measured using the scale named "Toronto Symptom Assessment System for Wound(TSAS-W)"; the minimum and maximum values are 0 and 100 respectively, and higher scores mean a worse wound symptom reported by patients.
Measured: Baseline and day 42
Change from Baseline in Quality of life in breast cancer patients at day 42
measured using the scale named "Quality of Life instruments for Cancer Patients-Breast Cancer(QLICP-BR)". There are 37 items, and 5~10 and 27~32 are positive entries, and the rest are reverse entries. Using Likert 5-level scoring method, the total score is 36~180 points. The higher the total score, the better the quality of life. Only 35 items were used in this study.
Measured: Baseline and day 42
Change from Baseline in Social support at day 42
measured using the scale named "Social Support Rate Scale(SSRS)".The scale includes 10 items and 3 dimensions, with a total score of 11-59. The higher the total score, the better the social support.
Measured: Baseline and day 42
Change from Baseline in Anxiety at day 42
measured using the scale named "Self-rating Anxiety Scale(SAS)". SAS scale includes 20 items. If it is a positive scoring question, it will be rated as rough score 1, 2, 3 and 4 in turn; Reverse scoring questions (those with * sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SAS standard deviation is 50 points, of which 50 ~ 59 points are mild anxiety, 60 ~ 69 points are moderate anxiety, and more than 70 points are severe anxiety.
Measured: Baseline and day 42
Change from Baseline in Depression at day 42
measured using the scale named "Self-rating Depression Scale(SDS)". SDS scale includes 20 items and 10 positive scoring questions, which are rated as rough scores of 1, 2, 3 and 4 in turn; 10 reverse scoring questions (those with * sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SDS standard score is 53 points, of which 53-62 points are mild depression, 63-72 points are moderate depression, and more than 73 points are severe depression.
Measured: Baseline and day 42
Change from Baseline in Stigma at day 42
measured using the scale named "Stigma Scale for Chronic Illness 8-item version(SSCI-8items)". The scale is developed on the basis of the 24 item stigma scale for chronic illness (SSCI), with a total of 8 items, of which 3 items are from internal shame, 5 items are from external shame, and all items are positive. The five options of the scale are: No, little, sometimes, often, always, and assigned 1, 2, 3, 4, and 5 points respectively, with a total score of 8 to 40 points. The higher the score, the higher the level of shame.
Measured: Baseline and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start24 Jun 2022
- Primary completion24 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Fungating WoundStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457309
- Sponsor's protocol ID
- SYSKY-2022-024-01
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients Based on Symptom Management Theory
- ClinicalTrials.gov ID
- NCT05457309
- Acronym / sponsor ID
- SYSKY-2022-024-01
- Conditions
- Malignant Fungating Wound
- Keywords
- Breast cancer, Malignant fungating wounds, Symptom management, Wound care, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 24 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| malignant fungating wounds care regimen | Experimental | Procedure: malignant fungating wounds care regimenmalignant fungating wounds care regimen based on the evidences, expert consultation, pre-experiment and final determination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years old with pathologically confirmed diagnosis of breast cancer.
Key exclusion criteria (7 listed)
- Patients with mental illness or cognitive impairment and language expression deficiency.
- Patients who developed serious complications during the study and were unable to continue the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| malignant fungating wounds care regimen1) 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. | Procedure or surgery | malignant fungating wounds care regimen |
Primary outcome
Change from Baseline in Wound Size at day 42
Time frame: Baseline and day 42
described by "healing, improvement, maintenance, deterioration", where "wound healing" refers to 100% epithelialization of the wound, "wound improvement" refers to reduction of the wound area, "wound maintenance" refers to no change in the wound area, and "wound deterioration" refers to an increase in the wound area.
6 secondary outcomes
Change from Baseline in Wound symptoms at day 42
Time frame: Baseline and day 42
Change from Baseline in Quality of life in breast cancer patients at day 42
Time frame: Baseline and day 42
Change from Baseline in Social support at day 42
Time frame: Baseline and day 42
Change from Baseline in Anxiety at day 42
Time frame: Baseline and day 42
Change from Baseline in Depression at day 42
Time frame: Baseline and day 42
Change from Baseline in Stigma at day 42
Time frame: Baseline and day 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing malignant fungating wounds care regimen in people with Malignant Fungating Wound, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liangzhi Qiu, M.D. (+8615889962699, 772029778@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Wound Size at day 42 (time frame: Baseline and day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.