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

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

NCT ID: NCT05946993

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

Conditions: Official terms:
Neoplasm Metastasis
Kidney Neoplasms
Testicular Neoplasms
Penile Neoplasms

Conditions: Keywords:
cancer
prostate
survivorship

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Physiotherapy
Description: 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.
Arm group label: Intervention arm

Intervention type: Other
Intervention name: Dietitian Support
Description: 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.
Arm group label: Intervention arm

Intervention type: Other
Intervention name: Nursing and Psychosocial
Description: 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.
Arm group label: Intervention arm

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Men aged ≥ 18 years of age at the time of study enrolment. 2. Willing to participate in a 12-week intervention programme and follow up procedures as outlined in the Schedule of Activities section. 3. ECOG performance status 0-2. 4. 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. 5. 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. 6. Participation in other translational or interventional clinical trials is permitted provided the above disease-specific inclusion criteria are met. 7. Signed consent form by the participant or a legally authorized representative (LAR). Exclusion Criteria: 1. Persons who, in the opinion of the researcher or supervising clinician, are unable to cooperate adequately with the study protocol, for example those receiving systemic therapy for a concurrent cancer diagnosis, those with organ system dysfunction which would impact their safe participation in the study, or other uncontrolled medical illness that would impact their safe participation in the study. 2. Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship). 1. Note: Per discretion of PI as to whether may impact the outcome of this study intervention.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cork University Hospital

Address:
City: Cork
Zip: T12 DC4A
Country: Ireland

Status: Recruiting

Investigator:
Last name: Jack Gleeson, MB. BCh. BAO.
Email: Principal Investigator

Start date: May 8, 2023

Completion date: April 2025

Lead sponsor:
Agency: University College Cork
Agency class: Other

Collaborator:
Agency: Irish Cancer Society
Agency class: Other

Collaborator:
Agency: Cancer Research@UCC
Agency class: Other

Source: University College Cork

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05946993