NCT06222008

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

2.4 years

First QC Date

January 4, 2024

Last Update Submit

January 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Chemotherapy Symptoms

    Symptoms during chemotherapy,Examples include nausea, vomiting, hair loss, fatigue , etc.

    Average 1 year

Secondary Outcomes (1)

  • Chemotherapy symptom clusters

    Average 1 year

Interventions

Observational study, no intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postoperative patients with ovarian malignant tumors undergoing chemotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jiaxing

Jiaxing, China

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsRadiation InjuriesSyndrome

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersWounds and InjuriesDiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Chief Nurse

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 24, 2024

Study Start

January 30, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations