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Self-Management and Activation to Reduce Treatment-Related Toxicities (SMARTCare)

NCT03849950 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-09-30

No results posted yet for this study

Summary

The investigators will undertake a multi-centre, randomized controlled trial to implement and evaluate a proactive model of care (SMARTCare) during active cancer treatment that incorporates self-management support (SMS). Patients allocated to the control arm will receive care from ambulatory clinic nurses trained in SMS. Patients allocated to the intervention arm will will receive care from ambulatory clinic nurses trained in SMS, in addition to being given access to a web-based, self-management education program and nurse-led health coaching during the first four months following the first systemic therapy administration.

Conditions

Interventions

OTHER

SMARTCare

1. Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care. 2. An education program for patients in the intervention arm that targets training in core self-management skills and is comprised of an introduction and 5 education modules. 3. An introductory call from a health coach prior to initiating treatment and 5 subsequent calls: prior to the first dose of treatment; 7-14 days following the first dose of treatment; within 2 weeks of coaching session 2; and timing is flexible for the last 2 sessions, but to be completed within 4 months following the first dose of treatment. 4. Optional sub-study: A sub-set of patients will participate in an end of study interview to gain further insight into SMARTCare.

OTHER

Control

1\. Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care.

Sponsors & Collaborators

  • Cancer Care Ontario

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Monika Krzyzanowska, MD MPH · University Health Network, Toronto

  • Doris Howell, PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2020-09-28
Completion
2020-09-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849950 on ClinicalTrials.gov