Electronic data collection of QoL PROMS in Prostate cancer
| ISRCTN | ISRCTN67560441 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67560441 |
| Secondary identifying numbers | 32084 |
- Submission date
- 21/11/2016
- Registration date
- 05/12/2016
- Last edited
- 28/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Ms Sally Appleyard
Public
Public
Clinical Investigation & Research Unit
Royal Sussex County Hospitals, Eastern Road
Brighton
Brighton
BN2 5BE
United Kingdom
 ORCID ID |
0000-0001-8167-8048 |
|---|---|
| Phone | +44 1273 664437 |
| sally.appleyard@bsuh.nhs.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | ISRCTN67560441_PIS_22Nov16_V1.2.docx |
| Scientific title | Electronic data capture of Health Related Quality of Life Patient Reported Outcome Measures (PROMS). An exploratory study in Patients with Prostate Cancer. |
| Study acronym | PROMS |
| Study objectives | 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(s) | South Central- Hampshire A, 05/07/2016, ref: 16/SC/0289 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2015 |
| Completion date | 31/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Total final enrolment | 40 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 06/09/2016 |
| Date of final enrolment | 31/01/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Royal Sussex County Hosptial
Clinical Investigation & Research Unit
Eastern Road
Brighton
BN2 5BE
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
Eastbourne District General Hospital
Kings Drive
Eastbourne
BN21 2UD
United Kingdom
Eastbourne
BN21 2UD
United Kingdom
Worthing and Southlands Hospitals
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Worthing
BN11 2DH
United Kingdom
Sponsor information
Brighton and Sussex University Hospitals NHS Trust
Hospital/treatment centre
Hospital/treatment centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
| Phone | +44 1273 696955 |
|---|---|
| scott.harfield@bsuh.nhs.uk |
Funders
Funder type
Industry
Sanofi-Aventis
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in Clinical Oncology. 2017 resultts presented at the NCRI Cancer Conference in http://abstracts.ncri.org.uk/abstract/electronic-data-capture-of-qol-proms-an-exploratory-study-in-patients-commencing-palliative-treatment-for-prostate-cancer/. |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.2 | 22/11/2016 | 05/12/2016 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN67560441_PIS_22Nov16_V1.2.docx
- Uploaded 05/12/2016
Editorial Notes
28/06/2019: The following changes have been made:
1. A conference abstract link was added to the publication and dissemination plan.
2. The final enrolment number was added from the abstract.
06/02/2017: Cancer Help UK Lay summary link added.
