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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25589231