Psychosocial Screening for Neuroendocrine Tumor Patients
1 other identifier
observational
100
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2017
CompletedFirst Submitted
Initial submission to the registry
December 10, 2017
CompletedFirst Posted
Study publicly available on registry
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2020
CompletedDecember 13, 2017
August 1, 2017
2 years
December 10, 2017
December 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DT
Distress Thermometer
every 3 month until 24 month
Secondary Outcomes (3)
HADS
every 3 month until 24 month
SPBS
every 3 month until 24 month
CD-RISC
every 3 month until 24 month
Study Arms (1)
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.
Eligibility Criteria
Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)
You may qualify if:
- sign written informed consent form;
- age ≥ 18 years;
- pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);
You may not qualify if:
- \<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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Study Record Dates
First Submitted
December 10, 2017
First Posted
December 13, 2017
Study Start
August 9, 2017
Primary Completion
August 9, 2019
Study Completion
August 9, 2020
Last Updated
December 13, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share