Neuroendocrine TumorsNCT03372356
Psychosocial Screening for Neuroendocrine Tumor Patients
An observational study of Neuroendocrine Tumors, run by Peking University at 1 site in China.
Trial summary
This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2017to 9 Aug 2020
- 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
- All sexes
- Adult, Older adult
Study population: Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)
Who may be able to join
- sign written informed consent form;
- age ≥ 18 years;
- pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);
Who cannot join
- <18 years;
- Neuroendocrine carcinoma;
- History of psychiatric or psychologic illness;
- History of previous cancers or cancer distress;
- Patients with central nervous system(CNS) disorder；
- Severe, uncontrolled medical condition that would affect patients' compliance;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.
- Conditions
- Neuroendocrine Tumors
- Keywords
- DT, HADS, SPBS, CD-RISC, Psychosocial Screening
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neuroendocrine tumors | Patients with neuroendocrine tumors will be given access to an application that monitors distress, anxiety, depression, self-perceived burden, and resilience at regular intervals for 3 months lasting for 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DT
Distress Thermometer
Measured: every 3 month until 24 month
Secondary outcomes (3)
HADS
Hospital Anxiety and Depression Scale
Measured: every 3 month until 24 month
SPBS
Self-Perceived Burden Scale
Measured: every 3 month until 24 month
CD-RISC
Connor-Davidson Resilience Scale
Measured: every 3 month until 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start9 Aug 2017
- Primary completion9 Aug 2019 (estimated)
- Study completion9 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372356
- Sponsor's protocol ID
- PSNET
- Status last verified
- Aug 2017
- First submitted
- 10 Dec 2017
- Last updated
- 13 Dec 2017
- 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 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Screening for Neuroendocrine Tumor Patients
- ClinicalTrials.gov ID
- NCT03372356
- Acronym / sponsor ID
- PSNET
- Conditions
- Neuroendocrine Tumors
- Keywords
- DT, HADS, SPBS, CD-RISC, Psychosocial Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 9 Aug 2019 (estimated)
- Study completion
- 9 Aug 2020 (estimated)
- First posted
- 13 Dec 2017 (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 is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroendocrine tumors | – | –Patients with neuroendocrine tumors will be given access to an application that monitors distress, anxiety, depression, self-perceived burden, and resilience at regular intervals for 3 months lasting for 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)
Key inclusion criteria (3 listed)
- sign written informed consent form;
- age ≥ 18 years;
- pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);
Key exclusion criteria (6 listed)
- <18 years;
- Neuroendocrine carcinoma;
- History of psychiatric or psychologic illness;
- History of previous cancers or cancer distress;
- Patients with central nervous system(CNS) disorder；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DT
Time frame: every 3 month until 24 month
Distress Thermometer
3 secondary outcomes
HADS
Time frame: every 3 month until 24 month
SPBS
Time frame: every 3 month until 24 month
CD-RISC
Time frame: every 3 month until 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- 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 Neuroendocrine Tumors, run by Peking University 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 3 inclusion and 6 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 13 Dec 2017. 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?
DT (time frame: every 3 month until 24 month). 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 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.