Malignant TumorNCT05596344
Long-term Follow-up of Anxiety and Depression in Patients With Malignant Tumors
An observational study of Malignant Tumor and Anxiety, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study was a single-center prospective, real-world observational study with plans to enroll all eligible patients. The basic information, anxiety and depression, treatment and prognosis of these patients were collected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Tumor, Anxiety, Depression
- What is being tested?
- Hospital Anxiety and Depression Scale
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2023to 30 Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with malignant tumors diagnosed by pathology receiving inpatient treatment in Henan Cancer Hospital.
Who may be able to join
- Men and women of all ages are welcome.
- Pathological diagnosis of malignant tumor in our hospital.
- Received at least one hospitalization at this hospital.
- The expected survival time is greater than 1 year.
Who cannot join
- 1.There was no pathological report of malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Zhengzhou, Henan, 450008
Tian Zhichao, Dr., +8618737187831, tianzhichhaoyy@163.com
About this study
Official title: A Single-center, Real-world Prospective Observational Study of the Incidence and Development of Anxiety and Depression in Patients With Malignant Tumors
This study was a single-center prospective, real-world observational study with plans to enroll all eligible patients. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.
Read the detailed description
A total of 200 patients with malignant tumors will be enrolled in Henan Cancer Hospital. This study is a single-center prospective real-world observational study, and all eligible patients are planned to be enrolled. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.
- Conditions
- Malignant Tumor, Anxiety, Depression
- Being tested
- Hospital Anxiety and Depression Scale
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Anxiety and Depression ScaleOther
The basic information, anxiety and depression, treatment and prognosis of these patients were collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety Depression Scale
Confirmed in 1 day
Measured: Confirmed in 1 day
Hospital Anxiety Depression Scale
End of the treatment
Measured: End of the treatment
Hospital Anxiety Depression Scale
The treatment ended 3 months later
Measured: The treatment ended 3 months later
Hospital Anxiety Depression Scale
The treatment ended 6 months later
Measured: The treatment ended 6 months later
Hospital Anxiety Depression Scale
The treatment ended one year later
Measured: The treatment ended one year later
Hospital Anxiety Depression Scale
The treatment ended 2 years ago
Measured: The treatment ended 2 years ago
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start20 May 2023
- Primary completion30 Nov 2032 (estimated)
- Study completion30 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Jiaqiang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596344
- Sponsor's protocol ID
- ZZUSC-16
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Real-world Prospective Observational Study of the Incidence and Development of Anxiety and Depression in Patients With Malignant Tumors
- ClinicalTrials.gov ID
- NCT05596344
- Acronym / sponsor ID
- ZZUSC-16
- Conditions
- Malignant Tumor, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 Nov 2032 (estimated)
- Study completion
- 30 Nov 2032 (estimated)
- First posted
- 27 Oct 2022 (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.
This study was a single-center prospective, real-world observational study with plans to enroll all eligible patients. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.
Detailed description
A total of 200 patients with malignant tumors will be enrolled in Henan Cancer Hospital. This study is a single-center prospective real-world observational study, and all eligible patients are planned to be enrolled. The basic information, anxiety and depression, treatment and prognosis of these patients were collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with malignant tumors diagnosed by pathology receiving inpatient treatment in Henan Cancer Hospital.
Key inclusion criteria (4 listed)
- Men and women of all ages are welcome.
- Pathological diagnosis of malignant tumor in our hospital.
- Received at least one hospitalization at this hospital.
- The expected survival time is greater than 1 year.
Key exclusion criteria (1 listed)
- 1.There was no pathological report of malignancy.
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 |
|---|---|---|
| Hospital Anxiety and Depression ScaleThe basic information, anxiety and depression, treatment and prognosis of these patients were collected. | Other | – |
Primary outcome
Hospital Anxiety Depression Scale
Time frame: Confirmed in 1 day
Confirmed in 1 day
Hospital Anxiety Depression Scale
Time frame: End of the treatment
End of the treatment
Hospital Anxiety Depression Scale
Time frame: The treatment ended 3 months later
The treatment ended 3 months later
Hospital Anxiety Depression Scale
Time frame: The treatment ended 6 months later
The treatment ended 6 months later
Hospital Anxiety Depression Scale
Time frame: The treatment ended one year later
The treatment ended one year later
Hospital Anxiety Depression Scale
Time frame: The treatment ended 2 years ago
The treatment ended 2 years ago
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- 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.
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 Malignant Tumor and Anxiety, run by Henan Cancer Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 13 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Jiaqiang, Dr (13592413731, wjqwtj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety Depression Scale (time frame: Confirmed in 1 day). The study lists 6 primary outcomes in all. 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 13 Nov 2023.