Background: Poorly managed cancer treatment toxicities negatively impact quality of life, but little research has examined patient activation in self-management (SM) early in cancer treatment. Methods: We undertook a pilot randomized trial to evaluate the feasibility, acceptability, and preliminary effectiveness of the SMARTCare (Self-Management and Activation to Reduce Treatment Toxicities) intervention. This intervention included an online SM education program (I-Can Manage) plus 5 sessions of telephone cancer coaching in patients initiating systemic therapy for lymphoma or colorectal or lung cancer at 3 centers in Ontario, Canada, relative to a usual care control group. Patient-reported outcomes included patient activation (Patient Activation Measure [PAM]), symptom or emotional distress, self-efficacy, and quality of life. Descriptive statistics and Wilcoxon rank-sum tests were used to examine changes over time (baseline and at 2, 4, and 6 months) within and between groups. We used general estimating equations to compare outcomes between groups over time. The intervention group completed an acceptability survey and qualitative interviews. Results: Of 90 patients approached, 62 (68.9%) were enrolled. Mean age of the sample was 60.5 years. Most patients were married (77.1%), were university educated (71%), had colorectal cancer (41.9%) or lymphoma (42.0%), and had stage III or IV disease (75.8%). Attrition was higher in the intervention group than among control subjects (36.7% vs 25%, respectively). Adherence to I-Can Manage was low; 30% of intervention patients completed all 5 coaching calls, but 87% completed ≥1. Both the continuous PAM total score (P<.001) and categorical PAM levels (3/4 vs 1/2) (P=.002) were significantly improved in the intervention group. Conclusions: SM education and coaching early during cancer treatment may improve patient activation, but a larger trial is needed.
ClinicalTrials.gov Identifier: NCT03849950
Submitted June 28, 2022; final revision received October 11, 2022; accepted for publication November 4, 2022.
Author contributions: Conceptualization: Howell, Pond, Bryant-Lukosius, Powis, McGowan, Kukreti, Rask, Hack, Krzyzanowska. Data curation: Powis. Formal analysis: Pond, Makuwaza. Funding acquisition: Howell, Powis, Krzyzanowska. Investigation: Howell, Powis, Rask, Krzyzanowska. Methodology: Howell, Pond, Bryant-Lukosius, Powis, McGowan, Kukreti, Krzyzanowska. Project administration: Powis, Hack. Supervision: Howell, Krzyzanowska. Visualization: Howell. Writing–original draft: Howell. Writing–review & editing: Pond, Bryant-Lukosius, Powis, McGowan, Makuwaza, Kukreti, Rask, Hack, Krzyzanowska.
Disclosures: Dr. Howell has disclosed receiving institutional grant/research funding from AstraZeneca; and serving on a scientific advisory board and as a consultant for Carevive Systems, Inc. Dr. Pond has disclosed serving as a consultant for Profound Medical, Merck & Co., Inc., and AstraZeneca; and having equity/stock in Roche. Dr. Krzyzanowska has disclosed receiving grant/research support from EISAI, Ipsen, Eli Lilly, and Exelixis; and receiving honoraria from EISAI, Ipsen, and Eli Lilly. The remaining authors have disclosed that they have not received any financial considerations from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: Research reported in this publication was supported by the Canadian Institutes of Health Research (154129; M.K. Krzyzanowska).