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NCT06222008 Clinical Trial

Study on Symptom Clusters During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution

Ovarian Cancer Clinical Trial

Official title:
Correlation Study of Symptom Clusters and Negative Emotions During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06222008
Other study ID # FirstHJiaxing01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2022
Est. completion date June 30, 2024

Study information
Verified date January 2024
Source Affiliated Hospital of Jiaxing University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about in Patients treated with postoperative chemotherapy for ovarian tumors. The main questions it aims to answer are: • [What symptom clusters are present in patients treated with postoperative chemotherapy for ovarian tumors] • [Are there differences in symptom clusters for patients with different TCM body types] Participants will [complete questionnaires prior to the start of chemotherapy and after the 1st, 3rd, and 6th chemotherapy treatments].

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: Pathologic diagnosis of ovarian cancer, the treatment plan adopts surgery combined with chemotherapy. Age = 18 years old, know the real situation of the disease, the expected survival period > 1 year. General condition is good, no history of psychiatric disease, no serious heart, brain, liver, kidney function abnormality. Informed consent and voluntarily participate in this study. Exclusion Criteria: those who have other tumors or whose diagnosis is unclear. those who cannot communicate properly, understand the questionnaire or complete the scale assessment. those who receive additional psychological interventions during the study period.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no Intervention
Observational study, no intervention

Locations
Country Name City State
China The First Hospital of Jiaxing Jiaxing

Sponsors (1)
Lead Sponsor Collaborator
Yandi Zhu

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chemotherapy Symptoms Symptoms during chemotherapy,Examples include nausea, vomiting, hair loss, fatigue , etc. Average 1 year
Secondary Chemotherapy symptom clusters The internal consistency, content validity, and validity of the scale were verified by combining the 13 core symptom items in the Chinese Version of the M.D. Anderson Symptom Inventory (MDASI-C) with the 9 ovarian cancer-specific symptoms. All entries (22) are numbered "0" to "10" to represent the degree of symptoms from "nonexistent" to "worst imaginable", and the symptoms assessed ranged from "nonexistent" to "worst imaginable". "The onset of the assessed symptoms was limited to the last 24 hours. Average 1 year
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