Ovarian CancerNCT06222008
Study on Symptom Clusters During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution
An observational study of Ovarian Cancer and Radiotherapy Side Effect, run by Yandi Zhu at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Radiotherapy Side Effect, Symptom Cluster
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative patients with ovarian malignant tumors undergoing chemotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jiaxing
Jiaxing
Yandi Zhu, Master's degree student, 13736827674, hero-zaizhong@hotmail.com
About this study
Official title: 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].
- Conditions
- Ovarian Cancer, Radiotherapy Side Effect, Symptom Cluster
- Being tested
- no Intervention
- Medical subject headings
- Ovarian Neoplasms, Radiation Injuries, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no InterventionOther
Observational study, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Symptoms
Symptoms during chemotherapy,Examples include nausea, vomiting, hair loss, fatigue , etc.
Measured: Average 1 year
Secondary outcomes (1)
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.
Measured: Average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start30 Jan 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yandi Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yandi Zhu, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222008
- Sponsor's protocol ID
- FirstHJiaxing01
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study of Symptom Clusters and Negative Emotions During Chemotherapy in Ovarian Cancer Patients With Different Chinese Medicine Constitution
- ClinicalTrials.gov ID
- NCT06222008
- Acronym / sponsor ID
- FirstHJiaxing01
- Conditions
- Ovarian Cancer, Radiotherapy Side Effect, Symptom Cluster
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yandi ZhuUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative patients with ovarian malignant tumors undergoing chemotherapy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no InterventionObservational study, no intervention | Other | – |
Primary outcome
Chemotherapy Symptoms
Time frame: Average 1 year
Symptoms during chemotherapy,Examples include nausea, vomiting, hair loss, fatigue , etc.
1 secondary outcome
Chemotherapy symptom clusters
Time frame: Average 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Radiotherapy Side Effect, run by Yandi Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy Symptoms (time frame: Average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.