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Supporting Men with Advanced Genitourinary Cancers

A new study aims to improve care for men with advanced genitourinary cancers.

Brendan Noonan, P. Bredin, A. M. Cahill, S. Corkery, K. E. Johnston, K. Medved, A. M. Cusack, J. Hegarty, M. M. Saab, S. J. Cushen, R. Connolly, B. Palmer, D. M. Dahly, M. Murphy, R. M. Bambury, J. P. Gleeson

― 5 min read


Men's Cancer Care Men's Cancer Care Initiative facing advanced cancers. A study to enhance support for men
Table of Contents

With the rise in survival rates for cancer, it's important to look at how cancer and its treatment affect people's health and lives over time. A patient-centered approach is needed to ensure survivors receive the support they need. Creating a standard path for cancer survivorship can help address ongoing issues, support patients through different stages of their treatment, and help them live fulfilling lives after their diagnosis.

Genitourinary Cancers

Genitourinary cancers affect the urinary system and reproductive organs in men, including types like prostate, testicular, and kidney cancer. They make up about 40% of all invasive cancers. Most research into supportive care has focused on prostate cancer. Strategies like cognitive-behavioral therapy, exercise programs, and rehabilitation have shown promise for improving outcomes. However, these improvements often don't last long, highlighting the need for a more comprehensive approach. Many men with prostate cancer experience anxiety, depression, and feelings of hopelessness, which means there's a strong need for targeted supportive care.

Study Overview

This paper explains a study that will look at the feasibility and acceptability of a detailed intervention program for men dealing with advanced genitourinary cancers. The program, known as "The LIAM Mc Trial," aims to provide support alongside regular check-ups and treatment.

Study Design

The LIAM Mc Trial is a single-arm study focusing on the survivorship program for men with advanced genitourinary cancers. The program includes physiotherapy, diet advice, nursing support, and counseling, along with referrals to available services. Participants will work in groups of six and will receive personalized care plans. The study has two phases: a Pilot Phase with the first group of six men, followed by an Expansion Phase.

Before starting the main study, a review of 30 previous studies highlighted the lack of research on men with non-prostate genitourinary cancers. This finding helped shape the Pilot Phase, focusing initially on six men with advanced prostate cancer. The Steering Group set the number of participants based on available resources and the need to ensure safety and quality in interventions.

The study will also include a mixed-method evaluation to look at the context and factors that influence outcomes. This evaluation will use the LOGIC model to clearly present the relationships between resources, activities, and results.

Ethics and Participants

The study will follow strict ethical guidelines and has received approval from the relevant ethics committee. It will involve men aged 18 and older with advanced genitourinary cancer who are stable on treatment. Participants will be recruited from three hospitals in Ireland. A target of 72 men will be involved, with recruitment expected to take 24 months.

All participants will receive detailed information about the study and will need to give informed consent before joining. Data from participants will be collected using the Castor Electronic Data Capture platform.

Intervention Program

The 12-week intervention program includes visits twice a week. Each session will involve various healthcare professionals working together to provide the necessary support. The program will be delivered in a dedicated rehabilitation gym and will include supervised exercise, diet advice, and psychological support. Participants will develop an individualized exercise plan based on their health.

At the beginning of the program, men will receive a personal assessment and education on exercise, diet, and symptom management. The assessment will identify their current needs and ensure they receive appropriate care. A focus will be placed on discussing sensitive topics related to cancer treatment.

Throughout the program, men will also have access to additional resources and Support Services, including counseling and social work. The goal is to create a safe space for discussing issues affecting their Quality Of Life.

Follow-up and Evaluation

Participants will be monitored throughout the study. After completing the 12-week program, men will undergo follow-up assessments at six months. Their experiences will be gathered through focus groups and public engagement meetings, allowing for continuous feedback on the program.

Study Goals

The primary aim of the study is to determine if the intervention program can be effectively introduced into routine follow-up care for men with advanced genitourinary cancers. Secondary goals include assessing the program's impact on quality of life, fatigue, body weight, muscle strength, and nutritional health.

Measuring Success

Data collection will happen at key points: at the beginning, after the 12-week program, and at the six-month follow-up. Specific tools will be used to measure outcomes related to quality of life, fatigue, body composition, and dietary intake. Participants will also give feedback on the resources they accessed and their overall satisfaction with the program.

Risks and Data Management

Throughout the study, any adverse events linked to the intervention will be recorded. Participants will have the option to skip any questions they don't feel comfortable answering. Data will be managed securely, ensuring participants' confidentiality.

Sample Size and Analysis

The study aims to involve 72 men, accounting for potential withdrawals. The analysis will include both quantitative and qualitative data, looking deeply into the results and participants' experiences.

Conclusion

The LIAM Mc Trial aims to fill gaps in care for men with advanced genitourinary cancers, focusing on the unique needs of these patients. By developing a comprehensive support program, the study seeks to improve the quality of life for these men and ensure they receive the necessary resources during their cancer journey. The insights gained could inform future practices and lead to better care for all men facing similar challenges.

Original Source

Title: Study Protocol: LIAM Mc Trial (Linking in with Advice and supports for men impacted by metastatic cancer)

Abstract: BackgroundThe 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 Mens Health Initiative supportive care intervention programme in Ireland. MethodsThis is a single-arm feasibility study involving a 12-week mens 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 mens 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. DiscussionThe 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 participants identified needs. Findings will provide direction for the implementation of future supportive care programmes for mens 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.

Authors: Brendan Noonan, P. Bredin, A. M. Cahill, S. Corkery, K. E. Johnston, K. Medved, A. M. Cusack, J. Hegarty, M. M. Saab, S. J. Cushen, R. Connolly, B. Palmer, D. M. Dahly, M. Murphy, R. M. Bambury, J. P. Gleeson

Last Update: Oct 27, 2024

Language: English

Source URL: https://www.medrxiv.org/content/10.1101/2024.10.26.24316178

Source PDF: https://www.medrxiv.org/content/10.1101/2024.10.26.24316178.full.pdf

Licence: https://creativecommons.org/licenses/by/4.0/

Changes: This summary was created with assistance from AI and may have inaccuracies. For accurate information, please refer to the original source documents linked here.

Thank you to medrxiv for use of its open access interoperability.

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