Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
160

Summary

Conditions
  • Colo-rectal Cancer
  • Lung Cancer
  • Lymphoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Self-management describes patient's behaviours and skills to manage the physical and psychosocial impact of their illness. Empirical evidence shows that patient activation in self-management results in improved disease control and quality of life (QOL), and lower emergency department visits and hosp...

Self-management describes patient's behaviours and skills to manage the physical and psychosocial impact of their illness. Empirical evidence shows that patient activation in self-management results in improved disease control and quality of life (QOL), and lower emergency department visits and hospitalizations (ED+H) and costs in other chronic conditions. Previous research conducted by the investigators of this study has shown that the quality of SMS in ambulatory care was poor and patients felt unprepared to manage treatment-related toxicities. Building on previous work, this study will evaluate a multi-faceted proactive model of care that includes: (1) training in self-management support (SMS) strategies for ambulatory nursing staff; (2) a web-based self-management education program for patients; and (3) provision of proactive, nurse-led health coaching during the first four months following the first systemic therapy administration. Using a computer-generated permuted blocks randomization scheme (permuted blocks of random size) stratified by cancer type and centre, 160 evaluable patients will be enrolled across the three participating regional cancer centres. 80 patients will be randomized to the intervention arm and 80 to the control arm. The primary objective of this study is to compare the feasibility and acceptability of the SMARTCare intervention to the active comparator (control arm). The secondary objectives are to: (1) assess the effect of the intervention on symptom control, health-related quality of life, psychological distress, patient activation and self-efficacy; (2) evaluate the effect of the intervention on service outcomes: ED+H and resource utilization; and (3) evaluate implementation outcomes: fidelity, adherence and adoption. In addition, patients randomized to the intervention arm will be asked to participate in a sub-study interview at the end of the study to gain further knowledge about the SMARTCare intervention components from the patient's perspective.

Tracking Information

NCT #
NCT03849950
Collaborators
Cancer Care Ontario
Investigators
Principal Investigator: Monika Krzyzanowska, MD MPH University Health Network, Toronto Principal Investigator: Doris Howell, PhD University Health Network, Toronto