Clinical trial · Interventional
RAW Study Version 3.4
Does Increasing Research Awareness Impact on Accrual? A Feasibility Study. Protocol Version 3.4 Dated April 2005.
NCT00280722CI-TRIAL-00030163withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| patient information leaflet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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)
- measure
- Whether existing and/or acquired research awareness may influence participation.
- measure
- Development of the research information leaflet.
- measure
- Development, testing and validation of the data collection methods.
- measure
- Number of questionnaires returned.
- measure
- Realistic data for estimating sample sizes in the larger study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient requiring first oncology appointment whose appointments are being planned more than 3 days in advance. (see exclusion criteria for reason) 2. 18 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.) - Exclusion Criteria: 1. 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. 2. Vulnerable patients under 18 years of age.
References
Publications (10)
- BACKGROUNDStevens 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 14998605
- BACKGROUNDFallowfield 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 9893627
- BACKGROUNDMohide 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 8664135
- BACKGROUNDEllis 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 11481363
- BACKGROUNDEllis 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 12196367
- BACKGROUNDJenkins 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 11139312
- BACKGROUNDHarrison 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.