Condition category
Cancer
Date applied
20/03/2017
Date assigned
06/04/2017
Last edited
16/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Ms Sally Appleyard

ORCID ID

http://orcid.org/0000-0001-8167-8048

Contact details

Clinical Investigation & Research Unit
Royal Sussex County Hospitals
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44
sally.appleyard@bsuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32210

Study information

Scientific title

Quality of Life After Bladder Cancer - a qualitative interview study (Q-ABC-QIS)

Acronym

Study hypothesis

The aim of this study is to use in depth interviews to explore the “lived experience” of patients and carers who have undergone, or supported someone through, treatment for bladder cancer.

Ethics approval

South East Coast: Brighton & Sussex REC, 01/02/2017, ref: 16/LO/1638

Study design

Non-randomised; Observational; Design type: Qualitative

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Cancer, Primary sub-specialty: Bladder Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract

Intervention

Participants will have a single interview lasting approximately one hour. This will be at their home or hospital depending on the preference of the participant. There is no follow-up.

The interview takes place 1-2 years after treatment. The interview involves discussion of how the cancer and treatment have impacted on their (for patients)/their relative/friend’s and their own (for carers) quality of life, including physical and emotional changes. The discussion will also cover their (for patients)/their relative/friend’s experience of deciding between treatments, if a choice was offered.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Quality of Life of patients and carers following radical treatment for bladder cancer, explored using interviews, at a single time point between 1-2 years post treatment.

Secondary outcome measures

1. Experience of the decision-making process relating to radical treatment for bladder cancer, explored using interviews, at a single time point between 1-2 years post treatment
2. Comparative experience of patients and carers, explored using interviews, at a single time point between 1-2 years post treatment

Overall trial start date

01/03/2016

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients > 18 years
2. Diagnosis of Muscle invasive bladder cancer
3. Treated with either radical cystectomy or radical (chemo-)radiotherapy between 1 and 2 years prior to study.
4. English speaking sufficient for in depth interview

Carer:
1. Informal carer of a person who fulfils 1-3 above (recognising that this person may no longer fulfil a “caring” role but did so during treatment)
2. English speaking sufficient for in depth interview

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

Recurrent disease

Recruitment start date

02/01/2017

Recruitment end date

01/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Sussex County Hosptial
Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Eastbourne District General Hospital
Kings Drive
Eastbourne
BN21 2UD
United Kingdom

Trial participating centre

Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Sponsor information

Organisation

Brighton and Sussex University Hospitals NHS Trust

Sponsor details

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 1273 696955 ext 7497
scott.harfield@bsuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Pelican Cancer Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Findings will be submitted for publication in high-impact peer reviewed journals.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from sally.appleyard@bsuh.nhs.uk

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

16/10/2017: Cancer Help UK lay summary link added to plain English summary field 15/09/2017: Internal review. 06/06/2017: Internal review. 21/04/2017: The participant information sheets have been uploaded.