Study Protocol: LIAM Mc Trial (Linking In with Advice and supports for Men impacted by Metastatic cancer)
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Background
The improved survival rate for many cancers in high-income countries demands a coordinated multidisciplinary approach to survivorship care and service provision to ensure optimal patient outcomes and quality of life. This study assesses the feasibility of introducing a Men’s Health Initiative supportive care intervention programme in Ireland.
Methods
This is a single-arm feasibility study involving a 12-week men’s cancer survivorship programme alongside routine follow-up care in patients with advanced genitourinary malignancies. Men with advanced/metastatic genitourinary cancer (including prostate, kidney, urothelial tract, testicular or penile cancer), are eligible to enrol, with a target of 72 participants over a 2-year period.
The intervention programme entails a twice-weekly physiotherapy-led exercise programme, along with dietetics, nursing, and psychosocial components, and regular signposting to additional available services. A Pilot Phase involving analysis of data from the first group of 6 participants to complete the programme is planned, before an Expansion Phase. Assessments will occur at baseline, on completion of the 12-week intervention, and 6 months post-intervention, and will include analyses of exercise/activity levels, body composition, muscle strength, psychological wellbeing, quality of life and resources utilised.
The primary endpoints are to determine the feasibility and acceptability of introducing a men’s cancer survivorship intervention programme into routine follow-up care in patients with advanced genitourinary malignancies. Secondary endpoints include impact of the intervention programme on quality of life, cancer-related fatigue, maintenance of weight, changes in body composition and changes in dietary intake and diet quality over the study period, as well as self-care agency and its relationship to quality of life and symptoms experienced. A process evaluation will capture the experiences of participation in the study, and the healthcare costs will be examined as part of the economic analysis.
Ethical approval was granted in November 2022, with recruitment commencing in May 2023.
Discussion
The programme described in this protocol provides a supportive and safe environment for the introduction of self-care interventions using a small group-based format supported by individualised counselling according to the participant’s identified needs. Findings will provide direction for the implementation of future supportive care programmes for men’s cancer survivorship care.
ClinicalTrials.gov Identifier: NCT05946993 ; Cancer Trials Ireland #: CTRIAL-IE 23-18; Irish Cancer Society (ICS) Study reference: MHI22BAM, UCC Sponsor Study Code: 22052.
