Condition category
Cancer
Date applied
28/07/2011
Date assigned
02/12/2011
Last edited
10/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Trish Holch

ORCID ID

Contact details

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

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

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/

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/03/2016: No publications found, verifying study status with principal investigator