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

NCT05946993 | Active Not Recruiting

• 1 other identifier: 22052
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

cancer; prostate; survivorship

Outcome Measures

Primary Outcomes (4)

• Feasibility as assessed by a purposefully designed feasibility questionnaire

  The feasibility of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary cancer. Purposefully designed feasibility questionnaire will be used. All scores will be linearly transformed to a 0 to 100 scale.

  At week 12

• Feasibility as assessed by a purposefully designed feasibility questionnaire

  The feasibility of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary cancer. Purposefully designed feasibility questionnaire will be used. All scores will be linearly transformed to a 0 to 100 scale.

  At 6-month post intervention timepoint

• The acceptability of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary cancer

  Purposefully designed feasibility questionnaire will be used. All scores will be linearly transformed to a 0 to 100 scale.

  At week 12

• The acceptability of introducing a men's cancer survivorship programme into routine follow up care in patients with advanced genitourinary cancer

  Purposefully designed feasibility questionnaire will be used. All scores will be linearly transformed to a 0 to 100 scale.

  At the 6-month post intervention timepoint

Secondary Outcomes (16)

• Change from Baseline in Health related-Quality of Life Questionnaire (QLQ) scores assessed by European Organization for the Research and Treatment of Cancer (EORTC)

  Baseline and at the end of the 12-week programme

• Change from Baseline in Fatigue related-Quality of Life Questionnaire (QLQ) scores

  Baseline and at the end of the 12-week programme

• Change from Baseline in weight.

  Baseline and the programme endpoint (12 weeks).

• Change from Baseline in muscle strength and mass.

  Baseline and the programme endpoint (12 weeks).

• Change from Baseline in 6-minute walk test.

  Baseline and the programme endpoint (12 weeks).

Study Arms (1)

Intervention arm

OTHER

Participants will attend 12-week programme that will include twice weekly exercise and assessment sessions.

Other: Physiotherapy; Other: Dietitian Support; Other: Nursing and Psychosocial

Interventions

Physiotherapy OTHER

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.

Intervention arm

Dietitian Support OTHER

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.

Intervention arm

Nursing and Psychosocial OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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:

You may not qualify if:

• 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.
• Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship).
• Note: Per discretion of PI as to whether may impact the outcome of this study intervention.

Sponsors & Collaborators

• Irish Cancer Society: collaborator
• University College Cork: lead
• Cancer Research@UCC: collaborator

Study Sites (1)

Cork University Hospital

Cork, Cork, T12 DC4A, Ireland

Location

Related Publications (1)

• Noonan B, Bredin P, Cahill AM, Corkery S, Johnston KE, Medved K, Cusack AM, Hegarty J, Saab MM, Cushen SJ, Connolly R, Palmer B, Dahly D, Murphy M, Bambury RM, Gleeson JP. Study protocol: LIAM Mc trial (Linking In with Advice and supports for Men impacted by Metastatic cancer). PLoS One. 2025 Apr 3;20(4):e0313454. doi: 10.1371/journal.pone.0313454. eCollection 2025.

  PMID: 40179061 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Testicular Neoplasms; Penile Neoplasms; Neoplasms

Interventions

Physical Therapy Modalities; Psychiatric Nursing

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Penile Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Nursing Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jack Gleeson, MB

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: July 14, 2023
• Study Start: May 8, 2023
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-03

Locations

IE (1)