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Trial record 11 of 2826 for:    tumor | Neuroendocrine Tumors

Psychosocial Screening for Neuroendocrine Tumor Patients

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ClinicalTrials.gov Identifier: NCT03372356
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Tracking Information
First Submitted Date December 10, 2017
First Posted Date December 13, 2017
Last Update Posted Date December 13, 2017
Actual Study Start Date August 9, 2017
Estimated Primary Completion Date August 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2017)
DT [ Time Frame: every 3 month until 24 month ]
Distress Thermometer
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 10, 2017)
  • HADS [ Time Frame: every 3 month until 24 month ]
    Hospital Anxiety and Depression Scale
  • SPBS [ Time Frame: every 3 month until 24 month ]
    Self-Perceived Burden Scale
  • CD-RISC [ Time Frame: every 3 month until 24 month ]
    Connor-Davidson Resilience Scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychosocial Screening for Neuroendocrine Tumor Patients
Official Title Psychosocial Screening for Neuroendocrine Tumor Patients
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)
Condition Neuroendocrine Tumors
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 10, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 9, 2020
Estimated Primary Completion Date August 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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;
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03372356
Other Study ID Numbers PSNET
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Shen Lin, Peking University
Study Sponsor Peking University
Collaborators Not Provided
Investigators Not Provided
PRS Account Peking University
Verification Date August 2017