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

Recruiting

• Conditions: Radiotherapy Side Effect; Ovarian Cancer; Symptom Cluster

• Registration Number: NCT06222008
• Lead Sponsor: Yandi Zhu

Brief 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 \[complete questionnaires prior to the start of chemotherapy and after the 1st, 3rd, and 6th chemotherapy treatments\].

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-15
• Last Update Submitted: 2024-01-15
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemotherapy Symptoms	Average 1 year	Symptoms during chemotherapy,Examples include nausea, vomiting, hair loss, fatigue , etc.

Secondary Outcome Measures

Name	Time	Method
Chemotherapy symptom clusters	Average 1 year	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.

Trial Locations

Locations (1)

The First Hospital of Jiaxing; 🇨🇳 Jiaxing, China