Psychosocial Screening for Neuroendocrine Tumor Patients | NCT03372356

Studies
Psychosocial Screening for Neuroendocrine Tumor Patients

NCT03372356

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Dec 13, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Neuroendocrine Tumors

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2017Actual

Primary Completion Date

Aug 9, 2019Estimated

Completion Date

Aug 9, 2020Estimated

First Submitted Date

Dec 10, 2017

First Submission Date that Met QC Criteria

Dec 10, 2017

First Posted Date

Dec 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2017

Last Update Posted Date

Dec 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking UniversityPrincipal Investigator

Lead Sponsor

Peking UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DT	Distress Thermometer	every 3 month until 24 month

Secondary Outcomes

Measure	Description	Time Frame
HADS	Hospital Anxiety and Depression Scale	every 3 month until 24 month
SPBS	Self-Perceived Burden Scale	every 3 month until 24 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sign written informed consent form;
age ≥ 18 years;
pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);

Exclusion Criteria:

<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;

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital	Recruiting	Beijing	Beijing Municipality	100142	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018358	Neuroendocrine Tumors

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided