Project 465323

TOward a comPrehensive supportive Care intervention for Older men with metastatic Prostate cancer: a pilot RCT and process evaluation (TOPCOP3)

465323

TOward a comPrehensive supportive Care intervention for Older men with metastatic Prostate cancer: a pilot RCT and process evaluation (TOPCOP3)

$100,000
Project Information
Study Type: Unclear
Research Theme: Clinical
Abstract Summary

Challenge: Androgen receptor axis-targeted agents (ARATs) such as abiraterone and enzalutamide are now often used to treat metastatic prostate cancer (mPC). They improve survival but cause substantial side effects, particularly in older men. These side effects reduce quality of life (QOL), and may lead men to stop treatment early. Studies show that remote symptom monitoring (RSM) can improve QOL and reduce hospital visits, and patients stay on treatment longer. However, these studies were mainly of younger people receiving chemotherapy. Older men on oral drugs like ARATs face different challenges. Three studies showed that geriatric assessment and management (GA+M) reduces treatment side effects by 20%, improves QOL, and reduces hospital visits in older adults on chemotherapy. We do not know if this is true for ARATs. Goal: We plan to test RSM and GA+M in older men with mPC who are taking an ARAT. We want to see if RSM alone, GA+M alone, or RSM and GA+M together are practical and whether they reduce serious treatment side effects and improve QOL. Study Design: We will conduct this study at two Ontario hospitals. We will recruit men age 70 or older, who have mPC, and who are starting an ARAT. We plan to include 140 participants: 35 men in each of three test groups and one control group. Intervention: Men who receive GA+M will get recommendations and monthly follow up from an oncology nurse. The nurse will also connect them to community resources if needed. Men assigned to RSM will have symptom monitoring weekly; a cancer nurse will provide symptom management as needed. The control group will receive usual care including access to a 24x7 nurse triage line. Significance: This will be the first trial to evaluate 2 promising evidence-based approaches alone and together to improve treatment tolerability and QOL in older men with mPC on ARAT therapy. If results are positive, we will begin a bigger, more definitive study to improve the lives of older men with mPC.

No special research characteristics identified

This project does not include any of the advanced research characteristics tracked in our database.

Keywords
Factorial Design Feasibility Geriatric Assessment Geriatric Oncology Hormone Therapies Prostate Cancer Quality Of Life Randomized Controlled Trial Treatment Toxicity