TOward a comPrehensive Supportive Care Intervention for Older Men With Metastatic Prostate Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

GA+M Intervention: Typically 8 domains (cognition, comorbidities, falls risk, functional status, medication use, mood - depression, nutritional status, social support) are examined by a team consisting of a nurse and geriatrician. A GA has multiple benefits and has been recommended for all older adults considering chemotherapy by the American Society of Clinical Oncology (ASCO). For a GA to be most useful it needs to be followed by co-management of identified issues.

RSM intervention: Telephone-based, symptom management of patients with cancer

GA+RSM intervention: Combining a geriatric assessment and remote symptom control

Study summary

TOPCOP3 is a pilot factorial RCT of geriatric assessment and management, remote symptom monitoring, both interventions or neither, accompanied by an embedded process evaluation. This design is widely used to guide the evaluation of complex interventions and provides important data to aid design of larger RCTs. The trial itself falls within pilot trial goals including obtaining variance estimates for outcomes, assessment of recruitment potential, and understanding implementation issues vital to designing a larger trial. The investigators have clear feasibility objectives and an analytic plan as well as criteria to determine success and strong support from cancer advocacy and policy groups.

Eligibility

Primary outcome measure(s)

• Number of participants with Grade 3-5 Toxicity — 6 months
  Grade 3-5 toxicity. This will be coded as at least one grade 3-5 toxicity vs none, measured based on review of clinical notes supplemented by interviews with patients by trained research staff and verified by a blinded physician. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
• Health related quality of life in patients with metastatic prostate cancer — 6 months
  QOL will be measured by patient self-report using the EQ-5D-5L, which is the EuroQol 5 dimensions of health questionnaire. This is a widely used, psychometrically valid brief generic QOL questionnaire.

Trial sites (3)

More University Health Network, Toronto trials in Canada

Other trials for the same condition