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Psychosocial Screening for Neuroendocrine Tumor Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03372356
Recruitment Status : Unknown
Verified August 2017 by Shen Lin, Peking University.
Recruitment status was:  Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Shen Lin, Peking University

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.

Condition or disease
Neuroendocrine Tumors

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Screening for Neuroendocrine Tumor Patients
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : August 9, 2019
Estimated Study Completion Date : August 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.

Primary Outcome Measures :
  1. DT [ Time Frame: every 3 month until 24 month ]
    Distress Thermometer

Secondary Outcome Measures :
  1. HADS [ Time Frame: every 3 month until 24 month ]
    Hospital Anxiety and Depression Scale

  2. SPBS [ Time Frame: every 3 month until 24 month ]
    Self-Perceived Burden Scale

  3. CD-RISC [ Time Frame: every 3 month until 24 month ]
    Connor-Davidson Resilience Scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03372356

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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Shen Lin, Professor    010-88196561   
Principal Investigator: Shen Lin, professor         
Sponsors and Collaborators
Peking University
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Responsible Party: Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking University Identifier: NCT03372356    
Other Study ID Numbers: PSNET
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shen Lin, Peking University:
Psychosocial Screening
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue