Psychosocial Screening for Neuroendocrine Tumor Patients

Neuroendocrine Tumors Clinical Trial

Official title:

Psychosocial Screening for Neuroendocrine Tumor Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03372356
• Other study ID #: PSNET
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2017
• Last updated: December 10, 2017
• Start date: August 9, 2017
• Est. completion date: August 9, 2020

Study information

• Verified date: August 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 9, 2020
• Est. primary completion date: August 9, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. sign written informed consent form;

2. age = 18 years;

3. pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67=20%);

Exclusion Criteria:

1. <18 years;

2. Neuroendocrine carcinoma;

3. History of psychiatric or psychologic illness;

4. History of previous cancers or cancer distress;

5. Patients with central nervous system(CNS) disorder;

6. Severe, uncontrolled medical condition that would affect patients' compliance;

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DT	Distress Thermometer	every 3 month until 24 month
Secondary	HADS	Hospital Anxiety and Depression Scale	every 3 month until 24 month
Secondary	SPBS	Self-Perceived Burden Scale	every 3 month until 24 month
Secondary	CD-RISC	Connor-Davidson Resilience Scale	every 3 month until 24 month