NCT03372356

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2020

Completed
Last Updated

December 13, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

December 10, 2017

Last Update Submit

December 10, 2017

Conditions

Keywords

DTHADSSPBSCD-RISCPsychosocial Screening

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

Age18 Years+
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

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

Locations