NCT02465424

Brief Summary

The purpose of this study is to determine which Health Related Quality of Life (HRQoL) tools patients with medullary thyroid cancer (MTC) find most helpful. The study will compare a generic cancer QoL tool with those developed for thyroid cancer patients and neuroendocrine tumour (NET) patients. The study will also evaluate clinicians' opinions on the clinical usefulness of the QoL tools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

June 1, 2015

Last Update Submit

May 21, 2018

Conditions

Keywords

quality of life questionnaires

Outcome Measures

Primary Outcomes (1)

  • Ranking of quality of life assessment tool by patients

    At recruitment

Study Arms (1)

questionnaire order

the order of presentation of the 4 quality of life questionnaires to the patients will be randomised to reduce the impact of boredom and habituation on responses

Other: quality of life questionnaires

Interventions

Randomised allocation of 4 validated quality of life questionnaires followed by study specific overview questionnaire

Also known as: health related quality of life tools
questionnaire order

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medullary thyroid cancer patients who are attending a thyroid cancer clinic in tertiary care setting in the NHS

You may qualify if:

  • Patients 16 years old or over who have a diagnosis of medullary thyroid cancer (inherited or sporadic)
  • Patients can be included at any time point after diagnosis

You may not qualify if:

  • Patients who have differentiated (papillary or follicular) thyroid cancer or anaplastic thyroid cancer or lymphoma of the thyroid.
  • Patients who do not sufficiently understand the English language or patients with learning disabilities, as these are standardised and validated questionnaires that are in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Velindre Hospital

Cardiff, CF14 2TL, United Kingdom

Location

University Hospitals of Coventry and Warwickshire

Coventry, United Kingdom

Location

Western general Hospital

Edinburgh, United Kingdom

Location

Imperial Hospital

London, United Kingdom

Location

St. Bartholomew's Hospital

London, United Kingdom

Location

Christie Hospital

Manchester, United Kingdom

Location

Weston Park Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • Laura Moss, MB BCh

    Velindre NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Clinical Oncologist

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 8, 2015

Study Start

December 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations