Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10522
Study information
Scientific title
Reviewing the validity of items for patients to self report adverse events: A patient cognitive interview study
Acronym
eRAPID
Study hypothesis
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
Leeds East Research Ethics Committee, 10/06/2011, ref: 11/YH/0159
Study design
Observational interventional pilot feasibility study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
A bank of adverse event items
Secondary outcome measures
No secondary outcome measures
Overall trial start date
18/07/2011
Overall trial end date
05/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 60
Participant 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
Recruitment start date
18/07/2011
Recruitment end date
05/12/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James Institute of Oncology
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS9 7TF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
NIHR - Programme Development Grants (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27551774