JMIR Publications

ABSTRACT

Background:

Supportive care (SC) refers to the prevention and management of complications of cancer and its treatment. While it has long been recognized as an important cancer care delivery component, a high proportion of patients face unaddressed SC needs calling for innovative approaches to deliver SC.

Objective:

This is a master protocol for a prospective cohort study evaluating the implementation of integrated proactive SC pathways across the cancer care continuum in our institution.

Methods:

This study is guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. The primary objective is to evaluate the impact of SC pathways in patient’s distress and unmet needs after 12-weeks, measured by the NCCN’s Distress Thermometer and problem list. Secondary objectives will focus on the pathway (macro-level) and each SC intervention (micro-level) evaluating: i) its reach (administrative data review); ii) short and long-term efficacy through its impact on quality of life (EQ-5D-5L, EORTC-QLQ-C30) and symptom burden (MDASI, HADS, ISI, EORTC-SHQ-C22); iii) adoption by patients and providers (administrative data review); iv) barriers and leverages for implementation (surveys and focus groups); v) maintenance (cost-consequence analysis). For the primary endpoint, patients participating in a SC pathway can enroll. For secondary endpoints, patients participating in SC interventions can enroll. Pilot evaluations with a minimum of 70 patients per pathway will be performed to generate mean Distress Thermometer scores and standard deviations informing the calculation of formal sample size needed for efficacy evaluation (cohorts will be enriched accordingly).

Results:

The protocol was approved by ethics committee and recruitment will start in December 2023.

Conclusions:

This study will inform the implementation of SC pathways of care.