Condition category
Cancer
Date applied
21/11/2016
Date assigned
05/12/2016
Last edited
21/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
Brighton
BN2 5BE
United Kingdom
+44 1273 664437
sally.appleyard@bsuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32084

Study information

Scientific title

Electronic data capture of Health Related Quality of Life Patient Reported Outcome Measures (PROMS). An exploratory study in Patients with Prostate Cancer.

Acronym

PROMS

Study hypothesis

The aim of this study to explore whether patients are willing and able to complete questionnaires to asses quality of life on a tablet computer, so that the information is entered electronically by the patient.

Ethics approval

South Central- Hampshire A, 05/07/2016, ref: 16/SC/0289

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

See additional files

Condition

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

Intervention

Participants will be asked to complete questionnaires relating to quality of life on a tablet computer – EORTC QLQ C30 (generic quality of life), EORTC PR25 (Prostate cancer specific module) and EQ-5D-5L (brief quality of life scale used to calculate QALYs).

Visit 1 takes place before commencing treatment and takes place either in clinic or at first treatment appointment. Meet Research Fellow and complete informed consent. Research fellow to complete demographics and “computer familiarity” questionnaires (paper). Participant to complete QoL questionnaires on tablet computer with support from Research Fellow if needed. Research fellow to complete “feasibility” paper questionnaires.

Visit 2 takes place 3 months from the start of treatment, and involves either an in clinic or at treatment appointment (meet research fellow and complete QoL questionnaires as above on tablet. Research fellow to complete feasibility questionnaire) or for the participant to complete questionnaires at home following an email reminder (esearch fellow to complete feasibility questionnaire either in person (at clinic or treatment appointment) or by phone).

Optional remote completion
At 1 and 2 months from start of treatment participants complete QoL questionnaires at home – following email reminder – either on desktop/laptop via web-based interface or on a mobile phone/tablet on an app.

Total duration of intervention = 3 months, no study follow-up beyond that date.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility will be assessed by measuring the time taken to complete the questionnaire (collected by electronic data collection system), patient reported feasibility (via feasibility questionnaire) and support needed from the researcher (via feasibility questionnaire) at baseline and 3 months, and measuring the rate of questionnaire completion at 3 months.

Secondary outcome measures

1. Health care professional reported feasibility (all clinic staff including recruiting oncologists) is measured via a HCP feasibility questionnaire at the end of the study
2. Uptake rate (impressions from recruiting doctors( is obtained from HCP feasibility questionnaire at the end of the study
3. Comparison with clinical decision at 3 months is assessed via comparison with decision whether or not to continue treatment and PSA measurement
4. Suitability of tools (sensitivity of tools to change in QoL) is measured via comparison between tools

Overall trial start date

01/10/2015

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients > 18 years
2. Diagnosis of prostate cancer not suitable for radical (curative) treatment
3. Commencing palliative systemic therapy (first or subsequent lines) – cytotoxic chemotherapy, modern hormonal agents (including enzalutamide and abiraterone) and radium 223.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

1. Already commenced treatment
2. Treated with androgen deprivation therapy, stilboestrol or dexamethasone only.
3. Treated with trial treatments that are not NICE or Cancer Drug Fund approved

Recruitment start date

06/09/2016

Recruitment end date

31/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Sussex County Hosptial
Clinical Investigation & Research Unit 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 and Southlands Hospitals
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
scott.harfield@bsuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Sanofi-Aventis

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in Clinical Oncology.

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

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/02/2017: Cancer Help UK Lay summary link added.