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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Radiotherapy Side Effect
• Symptom Cluster
• Syndrome

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