NCT05946993

Linking In With Advice and Supports for Men Impacted by Metastatic Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University College Cork · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the feasibility of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary malignancies.

Detailed description

Study design: Sequential Cohorts/ Parallel Sampling Groups Specific Aim: To assess the feasibility of a comprehensive multidisciplinary interventional programme for men living with advanced/metastatic genitourinary cancers Sample size: 72 Entry criteria: Advanced / metastatic genitourinary cancer (including prostate, kidney, urothelial tract, testicular and/or penile cancers), provided they meet the following conditions: * Prostate cancer - Histologically confirmed prostate cancer and must have commenced Androgen Deprivation Therapy (ADT) in the form of a gonadotropin-releasing hormone (GnRH) analogue or a GnRH receptor antagonist and/or an androgen receptor antagonist and/or undergone bilateral orchidectomy for prostate cancer. * Urothelial tract cancer - Stage II - IV urothelial tract cancer after completion of primary treatment with systemic therapy * Kidney cancer - Stage II - III renal cell cancer * Testicular cancer - Stage II - III testicular cancer after completion of primary treatment * Penile cancer - • Stage III - IV penile cancer after completion of primary treatment with systemic therapy * Currently on active surveillance (i.e. no active systemic therapies at present) or continuing on maintenance systemic therapy, provided they do not have ongoing adverse events which will impact their participation at the time of commencing the 12-week intervention. * Note: Men with resected disease (adjuvant setting) are eligible if they have commenced or completed adjuvant systemic therapy within the past 12 months and have recovered from these treatments at the time of commencing the 12-week programme from ongoing systemic therapy.

Conditions

• Survivorship
• Prostate Cancer
• Kidney Cancer
• Urothelial Tract/Bladder Cancer, Nos
• Testicular Cancer
• Penile Cancer

Interventions

Type	Name	Description
OTHER	Physiotherapy	participant will have 2 x 1h exercise classes per week with a physiotherapist, who will develop individualized plans based on medical history and scan reviews. Participants will be progressively guided through the programme, incrementally increasing in intensity or with modifications based on symptomatic presentation. This will be based on their baseline strength and cardiovascular fitness testing and grounded on evidence-based protocols previously demonstrating an effect in this patient population. Individualised tailored exercise programme which includes strength and conditioning.
OTHER	Dietitian Support	The main goal of the nutritional intervention is to improve the diet quality of each patient using a standardized nutrition assessment, offering evidence-based diet group education and developing personalized nutrition goals. Participants will be progressively guided through the nutrition education programme; with modifications to the individual's usual diet, thereby recognizing personal eating patterns and preferences, which form the basis for individualized dietary counselling. The dietary counselling identifies the type, amount, and frequency of feeding and specifies the caloric/protein level to attain, together with any restrictions and limited or increased individual dietary components.
OTHER	Nursing and Psychosocial	Nursing, Psycho-oncology, pastoral care and social work-led sessions to inform participants on items including diagnosis shock, acceptance, coping with relationship changes with their partner and their roles, fear of uncertainty and the future, medication management, masculinity (male values being strong, capable, independent), practical management of bills, and household tasks. There will be an inclusion of practical information sessions including health systems information and managing side effects such as urinary symptoms, hot flushes, penile shortening, and loss of body hair.

Timeline

• Start date: 2023-05-08
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2023-07-14
• Last updated: 2026-03-04

Locations

1 site across 1 country: Ireland