NCT00280722

Brief Summary

The purpose of this study is to investigate the feasibility of carrying out a full scale randomised controlled trial to compare the effects of giving additional information versus no additional information to patients prior to their first oncology appointment. Hypothesis: Patients with some awareness of research provided prior to clinic appointment in oncology and aware of the possibility of being invited to take part in a clinical trial are more likely to agree to participate.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

November 6, 2017

Status Verified

January 1, 2006

First QC Date

January 20, 2006

Last Update Submit

November 2, 2017

Conditions

Cancer

Keywords

RandomisedInterventionLeafletInformationAwarenessBehaviourResearch

Outcome Measures

Primary Outcomes (1)

  • Whether it is feasible to carry out a full scale randomised controlled trial to compare the effect of giving additional information versus no additional information to patients prior to their first oncology appointment.

Secondary Outcomes (5)

  • Whether existing and/or acquired research awareness may influence participation.

  • Development of the research information leaflet.

  • Development, testing and validation of the data collection methods.

  • Number of questionnaires returned.

  • Realistic data for estimating sample sizes in the larger study.

Interventions

patient information leafletBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • years or over. (The project will take place in adult clinic - all children \& young people under 18 are seen and cared for in the paediatric unit.) -
  • New patient referrals whose appointments are being planned in less than 3 days are often telephoned with details and will not have sufficient time to receive the information by post and read it prior to their appointment.
  • Vulnerable patients under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (10)

  • Stevens T, Ahmedzai SH. Why do breast cancer patients decline entry into randomised trials and how do they feel about their decision later: a prospective, longitudinal, in-depth interview study. Patient Educ Couns. 2004 Mar;52(3):341-8. doi: 10.1016/S0738-3991(03)00041-7.

    PMID: 14998605BACKGROUND

  • Fallowfield LJ, Jenkins V, Brennan C, Sawtell M, Moynihan C, Souhami RL. Attitudes of patients to randomised clinical trials of cancer therapy. Eur J Cancer. 1998 Sep;34(10):1554-9. doi: 10.1016/s0959-8049(98)00193-2.

    PMID: 9893627BACKGROUND

  • Mohide EA, Whelan TJ, Rath D, Gafni A, Willan AR, Czukar D, Campbell IB, Okawara GS, Neimanis M, Levine MN. A randomised trial of two information packages distributed to new cancer patients before their initial appointment at a regional cancer centre. Br J Cancer. 1996 Jun;73(12):1588-93. doi: 10.1038/bjc.1996.299.

    PMID: 8664135BACKGROUND

  • Ellis PM, Butow PN, Tattersall MH, Dunn SM, Houssami N. Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol. 2001 Aug 1;19(15):3554-61. doi: 10.1200/JCO.2001.19.15.3554.

    PMID: 11481363BACKGROUND

  • Ellis PM, Butow PN, Tattersall MH. Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Ann Oncol. 2002 Sep;13(9):1414-23. doi: 10.1093/annonc/mdf255.

    PMID: 12196367BACKGROUND

  • Jenkins V, Fallowfield L, Saul J. Information needs of patients with cancer: results from a large study in UK cancer centres. Br J Cancer. 2001 Jan 5;84(1):48-51. doi: 10.1054/bjoc.2000.1573.

    PMID: 11139312BACKGROUND

  • Harrison J. Why it is preferable to learn before the moment of diagnosis. In: Marie Curie Cancer Care in association with the Consumers' Advisory Group for Clinical Trials (CAG-CT) Conference: Towards Public Understanding of Clinical Trials, 16 Feb 1998, London.

    BACKGROUND

  • Blesing C, Palmer S, Mathews A. Thames Valley Cancer Research Network 3rd Annual Progress Report. 2004. http://www.tvcn.org.uk/research/annualreport.

    BACKGROUND

  • Mossman J, Boudioni M, Slevin ML. Cancer information: a cost-effective intervention. Eur J Cancer. 1999 Oct;35(11):1587-91. doi: 10.1016/s0959-8049(99)00195-1.

    PMID: 10673966BACKGROUND

  • Braunholtz DA, Edwards SJ, Lilford RJ. Are randomized clinical trials good for us (in the short term)? Evidence for a "trial effect". J Clin Epidemiol. 2001 Mar;54(3):217-24. doi: 10.1016/s0895-4356(00)00305-x.

    PMID: 11223318BACKGROUND

MeSH Terms

Conditions

NeoplasmsBehavior

Study Officials

  • Susan J Palmer

    Thames Valley Cancer Research Network

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 23, 2006

Study Start

January 1, 2006

Study Completion

November 1, 2006

Last Updated

November 6, 2017

Record last verified: 2006-01

Locations

GB(1)