NCT04324502

Brief Summary

Observational trial to assess the feasibility of monitoring patient reporting symptoms via mobile devices

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress98%
Jul 2020Jul 2026

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

November 9, 2020

Status Verified

March 1, 2020

Enrollment Period

6 years

First QC Date

March 25, 2020

Last Update Submit

November 5, 2020

Conditions

Neuroendocrine Neoplasms (Tumours)

Outcome Measures

Primary Outcomes (1)

  • Reporting compliance

    The primary endpoint is patient reporting compliance, defined as the number of days with any patient report submitted during the course of treatment. This will be unique to each course of therapy since they have different durations of treatment.

    4 years

Study Arms (1)

Neuroendocrine neoplasms (tumours)

Patients with a diagnosis of neuroendocrine neoplasm who are due to undergo one of the following treatments: chemotherapy, everolimus, sunitinib, somatostatin analogues, peptide receptor targeted therapy, embolization/ ablative therapies or surgery.

Eligibility Criteria

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

Patients with a diagnosis of neuroendocrine neoplasm who are due to undergo one of the following treatments: chemotherapy, everolimus, sunitinib, somatostatin analogues, peptide receptor targeted therapy, embolization/ ablative therapies or surgery.

You may qualify if:

  • Histologically confirmed diagnosis of a NET
  • Planned treatment for NET
  • Able to give informed consent
  • Able to understand the language of the questionnaires
  • A minimum expected survival of 6 months
  • All performance status is acceptable
  • years of age or over

You may not qualify if:

  • Concurrent malignancies for which they are undergoing treatment
  • No smartphone / device
  • Any physical, psychological or comprehension problems that prevents completion of questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Raj Srirajaskanthan

CONTACT

0203 299 3255r.srirajaskanthan@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

July 20, 2020

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

November 9, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

GB(1)