Electronic data collection of QoL PROMS in Prostate cancer

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN67560441

Enrollment

Registered

2016-12-05

Start date

2016-09-06

Completion date

Unknown

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Cancer, Primary sub-specialty: Prostate Cancer

Interventions

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

Eligibility

Sex/Gender

Male

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Contacts

Public ContactSally Appleyard

sally.appleyard@bsuh.nhs.uk+44 1273 664437

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026