NCT02836392

Brief Summary

This is a translational, multicentre questionnaire study. The study design follows that of a cross sectional, quantitative research approach. Data collection will involve self-administered, paper-based questionnaires. The method of data collection allows for a large sample size without major expense. The questionnaires are comprised of several questions examining areas such as demographic details, cancer diagnosis, understanding of the term 'clinical trials', attitudes to personal participation in cancer clinical research and the experience of patients who previously participated in a cancer clinical trial. The study will be opened in all interested hospitals in Ireland following initiation of the study at each site. Questionnaire completion will be seen as implied informed consent and no formal consent will need to be signed by the patient. The paper-based questionnaire responses will be electronically and anonymously recorded in a computer database to facilitate analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

14 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

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

June 27, 2016

Last Update Submit

August 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oncology patients' understanding of the term 'clinical trials' and their attitudes towards personal participation in cancer clinical research will be evaluated by questionnaire.

    1 year

Secondary Outcomes (2)

  • The patient related factors, including level of education and socioeconomic status that influence their decision regarding participation in a cancer clinical trial (CCT) will be explored by questionnaire.

    1 year

  • The patients' experience surrounding the discussion regarding CCT participation and their actual experience when enrolled in a CCT will be investigated by questionnaire.

    1 year

Interventions

QuestionnaireBEHAVIORAL

Eligibility Criteria

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

This is a translational, multicentre questionnaire study.

You may qualify if:

  • Clinical diagnosis of malignancy
  • Aged 18 years or older
  • Ability to complete the questionnaire or independently or with the help of a friend, relative, or staff member of the oncology department

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University Hospital Waterford

Waterford, Co Waterford, Ireland

Location

AMNCH

Tallaght, Dublin 24, Ireland

Location

St Vincent's University Hospital

Elm Park, Dublin 4, Ireland

Location

Beaumont Hospital

Beaumont Road, Dublin, 9, Ireland

Location

Bon Secours Hospital

Cork, Ireland

Location

Cork University Hospital

Cork, Ireland

Location

Saint Luke's Hospital Rathgar

Dublin, 6, Ireland

Location

Beacon Hospital

Dublin, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

St James Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

Letterkenny General Hospital

Letterkenny, Ireland

Location

University Hospital Limerick

Limerick, Ireland

Location

Sligo University Hospital

Sligo, Ireland

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 19, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

August 10, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Locations