eRAPID cognitive interview study

ISRCTN	ISRCTN58893387
DOI	https://doi.org/10.1186/ISRCTN58893387
Secondary identifying numbers	10522

Submission date: 28/07/2011
Registration date: 02/12/2011
Last edited: 25/10/2022

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-developing-new-questionnaire-about-side-effects-treatment-eRAPID

Study website

Contact information

Dr Trish Holch
Scientific

Level 3
Bexley Wing
St James Institute of Oncology
Beckett Street
Leeds
LS9 7TF
United Kingdom

Study information

Study design	Observational interventional pilot feasibility study
Primary study design	Observational
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	http://erapid.leeds.ac.uk/index.php/project-1/c-review-the-acceptability-and-applicability-of-items-via-cognitive-interviews-with-patients/iscrn-cogntive-interview-patient-information-sheet/
Scientific title	Reviewing the validity of items for patients to self report adverse events: A patient cognitive interview study
Study acronym	eRAPID
Study objectives	To review selected items for self-reporting of adverse events (AE) for acceptability, comprehension and clinical meaningfulness in a sample of breast, lung, renal, gynaecological and colorectal and cancer patients undergoing treatment at the Bexley Wing at St James University Hospital. The study will result in a bank of appropriate items reviewed for face and content validity, cultural relevance and comprehensively reflect local patient experience for remote self-report in the eRAPID project.
Ethics approval(s)	Leeds East Research Ethics Committee, 10/06/2011, ref: 11/YH/0159
Health condition(s) or problem(s) studied	Colorectal Cancer, breast cancer, gynaecological cancer, renal cancer, lung cancer
Intervention	We plan to approach 60 gynaecological, renal, breast, lung and colorectal cancer patients attending St James University Hospital Bexley Wing as an inpatient outpatient or day case who are receiving biological and chemotherapy. We will adopt a purposive sampling strategy balanced by age, gender and tumour group recruiting similar numbers until data saturation is achieved. Participants will be invited to take part in a cognitive interview, it is anticipated that this will take approximately 1 hour. The cognitive interview will involve two stages: 1. Completion of a questionnaire featuring items questions about the most commonly occurring AE for patients undergoing biological and chemotherapy treatment appropriate to the cancer site 2. Verbal probing which aims to reveal the cognitive processes relevant to answering survey questions and is an ideal way to pre-test questions in participants. The audio recorded verbal probing will apply to questions where patients have had difficulty answering a question and if they have experienced that symptom, to check for false negatives the researcher will probe a random selection of questions where patients have not indicated difficulty or symptomatology. Verbal probes will explore: 2.1. General views about completion of the questionnaire 2.2. Wwording of questions (particularly for cultural literacy) 2.3. Interpretation and comprehension of questions 2.4. Comprehensibility of the response scale,iv) difficulty
Intervention type	Other
Primary outcome measure	A bank of adverse event items
Secondary outcome measures	No secondary outcome measures
Overall study start date	18/07/2011
Completion date	05/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	UK Sample Size: 60
Total final enrolment	60
Key inclusion criteria	1. Undergoing chemotherapy and biological treatment with curative or palliative intent 2. Able and willing to give informed consent 3. Have gynaecological, breast, lung, renal and colorectal cancer 4. Male or female 5. Lower Age Limit 18 years
Key exclusion criteria	1. If taking part in other studies run by the group 2. If not able to read and understand English 3. If exhibiting overt psychopathology or serious cognitive dysfunction which would impede their being able to take part in the study
Date of first enrolment	18/07/2011
Date of final enrolment	05/12/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St James Institute of Oncology

Leeds
LS9 7TF
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS9 7TF
England
United Kingdom

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Research organisation

NIHR - Programme Development Grants (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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	01/09/2016		Yes	No
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
16/04/2018: Publication reference added.
10/03/2016: No publications found, verifying study status with principal investigator