Condition category
Cancer
Date applied
14/06/2011
Date assigned
28/09/2011
Last edited
09/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Galina Velikova

ORCID ID

Contact details

Level 4
Bexley Wing
St James' Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 113 206 7917
g.velikova@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C7775/A7424

Study information

Scientific title

A pilot quasi-experimental study to examine the impact of doctor training in how to respond to patient reported symptoms and health related quality of life

Acronym

Study hypothesis

Training oncologists to use HRQoL measures during routine chemotherapy review consultations will improve patient-centred communication. The data from this pilot study will provide an estimate of the impact of oncologist training and contribute to sample size calculations for a future randomised controlled trial.

Ethics approval

Leeds Central Reseach Ethics Committee, 10/02/2011 ref: 11/H1313/2

Study design

Pilot Quasi-experimental study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced stage breast, colorectalcancer, gynaecological cancers

Intervention

The study utilises a quasi-experimental design (before and after). 30 patients will be invited to take part before the participating oncologists attend the training programme and further 30 patients will be recruited after the training. Patients will be asked to complete a health related quality of life (HRQoL) questionnaire prior to routine chemotherapy review consultations. The participating oncologists (n = 3) will receive the results of the questionnaire and asked to incorporate these into the consultations. The before after study design will be used to assess the impact of a doctor training session to aid the facilitation of the HRQoL questionnaire into consultations.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Doctor-patient communication before and after the doctor training will be compared by:
1. Analysing audio-recordings of the consultations using content analysis and the measure of patient centred communication to determine the number of issues raised and the quality of discussions
2. Patient and oncologists views will be assessed using the Patient Perception of Patient Centredness questionnaire and the corresponding measure for doctors

Secondary outcome measures

Interviews with participating oncologists at the end of the study will explore their experience of the intervention before and after the training and opinions of the training programme to obtain suggestions for improving its’ content.

Overall trial start date

04/07/2011

Overall trial end date

28/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Are attending oncology clinics at St James' Institute of Oncology
2. Are receiving anti cancer chemotherapy for advanced stage of disease (breast, colorectal and gynaecological cancer)
3. Are able to give informed consent
4. Are able to read and understand English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Are below 18 years of age
2. Show overt exhibition of psychopathology or serious cognitive dysfunction which would impede them being able to take part in the study
3. Are deemed too ill by the oncology staff

Recruitment start date

04/07/2011

Recruitment end date

28/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 4, Bexley Wing
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

School of Medicine
The Worsley Medical & Dental Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
+44 113 343 0900
R.E.DeSouza@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) ref: C7775/A7424

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/03/2016: No publications found, verifying study status with principal investigator.