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

ISRCTN	ISRCTN81227579
DOI	https://doi.org/10.1186/ISRCTN81227579
Protocol serial number	C7775/A7424
Sponsor	University of Leeds (UK)
Funder	Cancer Research UK (CRUK) (UK) ref: C7775/A7424

Submission date: 14/06/2011
Registration date: 28/09/2011
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-impact-doctor-training-how-to-respond-to-patient-questionnaire-about-quality-of-life-QuEST-T2

Contact information

Prof Galina Velikova
Scientific

Level 4, Bexley Wing
St James' Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom

Phone	+44 113 206 7917
Email	g.velikova@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Pilot Quasi-experimental study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Leeds Central Reseach Ethics Committee, 10/02/2011 ref: 11/H1313/2
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	28/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Total final enrolment	60
Key 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
Key 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
Date of first enrolment	04/07/2011
Date of final enrolment	28/10/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Level 4, Bexley Wing

Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
30/04/2018: Publication reference added.
09/03/2016: No publications found, verifying study status with principal investigator.