Frailty in Older Adults With Prostate Cancer: a Prospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age65+
SponsorUniversity of Limerick
About this trial
Prostate cancer is the most common solid tumour cancer amongst men in Ireland, with almost 4,000 new cases diagnosed annually and a median age at diagnosis of 67 years. The incidence of frailty amongst cancer patients is high. Among patients undergoing systemic anti-cancer therapy, frailty increases the risk of treatment related toxicity, hospitalisation, and death and is associated with a poorer quality of life.
This study aims to describe the demographic, clinical and frailty characteristics of men living with prostate cancer in the Mid-West of Ireland. In addition, we will assess the predictive accuracy of three frailty screening tools currently used in Irish clinical practice,G8, CFS and PRISMA 7, for predicting poorer outcomes at baseline, 6 and 12 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults aged ≥65 years with a diagnosis of prostate cancer
Disqualifiers
Neither the patient nor the carer has sufficient proficiency in English sufficiently to complete consent or baseline assessment
Patients will be excluded if they present outside of research nurse (RN) operational hours( 8am and 5pm Monday - Friday).
Patients who are acutely unwell and unable to answer the questionnaire will also be excluded.
Trial population
All adults ≥ 65 years old with prostate attending outpatient clinics at the Mid-Western Cancer Centre between April 2026 and April 2027 (inclusive) will be considered eligible for participation in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Functional status
Patient global functioning as measured through the Barthel Index of Activities of Daily Living. The Barthel Index is a 10-item scale used to assess functional independence. The scoring varies across items: bowels, bladder, toilet use, feeding, dressing, and stairs are scored from from 0 (dependence or inability) to 2 (independence) grooming and bathing are scored either 0 (dependent or needs help) or 1 (independent) transfer and mobility are scored 0 (dependent), 1 (major help), 2 (minor help), or 3 (independent). The total score ranges from 0 to 20 and it is obtained by adding up the scores of each item. Lower scores indicated increased disability. In case of rehabilitation, changes of more than two points in the total score reflect a probable genuine change, and change on one item from fully dependent to independent is also likely to be reliable.
Time frame
Baseline, six months and twelve months after index visitSecondary outcomes
1
Patient quality of life
Quality of life assessed through the EuroQoL-5D-5L (EQ-5D-5L). The EQ-5D-5L is a standardised instrument developed by the EuroQoL Group (https://euroqol.org/euroqol/) to measure health-related quality of life. It includes a descriptive questionnaire assessing 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 5 levels of self-rated severity (1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems). Each dimension is scored separately from 0 to 5 and the patient's "health state" is coded as a 5-digit string. It also includes a vertical visual analogue scale (VAS) to record the patient's self-rated health on a scale from 0 (worst health) to 100 (best health). The score assigned by the patient represents the self-reported level of health.
Time frame
Baseline, Six months and twelve months after index visit.2
Incidence of healthcare utilisation
Percentages of patients who visit a general practitioner (GP), a public health nurse, outpatient departments, private consultations, home help, or allied health services after the ED index visit
Time frame
six months and 12 months following index visit3
Mortality
The rates of patients deceased will be captured at follow-up
Time frame
six months and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov