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

January 15, 2024 updated by: Yandi Zhu

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

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].

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Jiaxing, China
        • Recruiting
        • The First Hospital of Jiaxing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Postoperative patients with ovarian malignant tumors undergoing chemotherapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy Symptoms
Time Frame: Average 1 year
Symptoms during chemotherapy,Examples include nausea, vomiting, hair loss, fatigue , etc.
Average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy symptom clusters
Time Frame: 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.
Average 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yandi Zhu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstHJiaxing01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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