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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Men aged ≥ 18 years of age at the time of study enrolment.

• Willing to participate in a 12-week intervention programme and follow up procedures as outlined in the Schedule of Activities section.

• ECOG performance status 0-2.

• Recovery to CTCAE Grade ≤2 adverse events from all prior therapies, or adequately recovered adverse events whereby, whereby the PI feels they will not impact the participants ability to complete the 12-week intervention.

• Disease-specific inclusion criteria:

• Prostate cancer:

⁃ Histologically confirmed prostate cancer

⁃ 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. Men must have received last ADT treatment within 12 months of starting the programme or have ongoing treatment-related side effects at the time of commencing the programme if ADT has been discontinued due to toxicity.

⁃ Patients without histologically confirmed cancer are eligible if both the treating physician and the study PI agree that the patient's history is unambiguously indicative of advanced prostate cancer (e.g. high Prostate-specific antigen (PSA) responsive to ADT in prostate cancer).

• Urothelial tract cancer:

⁃ Stage II - IV urothelial tract cancer (muscle-invasive, node positive or metastatic disease) after completion of primary treatment with systemic therapy (including in the neoadjuvant or adjuvant setting) and/or surgery and recovery from these treatments to a satisfactory level.

⁃ Patients with metastatic disease continuing on maintenance systemic therapy are permitted if they do not have ongoing CTCAE Grade \>2 adverse events which will impact their participation at the time of commencing the 12-week programme.

• Kidney cancer:

• • Stage II - III renal cell cancer (clear cell or non-clear cell histologies permitted) after nephrectomy who required and have commenced or completed adjuvant systemic therapy within the past 12 months and have recovered from these treatments to CTCAE Grade ≤2 or do not have ongoing CTCAE Grade \>2 adverse events at the time of commencing the 12-week programme from ongoing systemic therapy.

• Or

• • Stage IV renal cell cancer (clear cell or non-clear cell histologies permitted) where the participants are continuing on stable dose of maintenance systemic therapy and do not have ongoing CTCAE Grade \>2 adverse events at the time of commencing the 12-week programme.

• Testicular cancer:

• • Stage II-III testicular cancer after completion of primary treatment with systemic therapy and/or surgery within the past 12 months and recovery of all adverse events from these treatments to CTCAE Grade ≤2.

• Penile Cancer:

⁃ Stage III - IV penile cancer (node positive, recurrent or metastatic disease) after completion of primary treatment with systemic therapy (including in the neoadjuvant or adjuvant setting) and/or surgery and recovery from these treatments to CTCAE Grade ≤2.

⁃ Patients with metastatic disease continuing maintenance systemic therapy are permitted if they do not have ongoing CTCAE Grade \>2 adverse events which will impact their participation at the time of commencing the 12-week programme.

• Participation in other translational or interventional clinical trials is permitted provided the above disease-specific inclusion criteria are met.

• Signed consent form by the participant or a legally authorized representative (LAR).

Locations
Other Locations
Ireland
Cork University Hospital
RECRUITING
Cork
Contact Information
Primary
Jack Gleeson, MB
jack.gleeson@hse.ie
0214922603
Backup
Anne Marie Cusack, BSc
acusack@ucc.ie
0879563385
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2026-04
Participants
Target number of participants: 72
Treatments
Other: Intervention arm
Participants will attend 12-week programme that will include twice weekly exercise and assessment sessions.
Sponsors
Collaborators: Irish Cancer Society, Cancer Research@UCC
Leads: University College Cork

This content was sourced from clinicaltrials.gov

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