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

Titre officiel

A Multi-Centre, Randomized Controlled Trial of Self-Management and Activation to Reduce Treatment-Related Toxicities in Patients Receiving Adjuvant or First-Line Metastatic Oral or Systematic Therapy for Colorectal, Lymphoma or Lung Cancer (SMARTCare)

Sommaire:

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.

Description de l'essai

Primary Outcome:

  • Reasons for non-participation
  • Reasons for premature discontinuation or withdrawal
  • Recruitment rate
  • Retention rate
  • Usage of I-Can-Manage (intervention arm only)
  • Compare the acceptability of the SMARTCare intervention to the active comparator by administering an Intervention Acceptability Questionnaire and conduct a thematic analysis of qualitative data from end of study interviews.
Secondary Outcome:
  • Patient Outcomes - Memorial Symptom Assessment Scale - Short Form (MSAS-SF) to evaluate the impact of the intervention on symptom control
  • Patient Outcomes - EQ-5D-5L to evaluate the impact of the intervention on health-related quality of life
  • Patient Outcomes - Hospital Anxiety and Depression Scale (HADS) to assess psychological distress
  • Patient Outcomes - Patient Activation Measure (PAM) to evaluate the impact of the intervention on patient activation
  • Patient Outcomes - Patient Reported Outcomes Measurement Information System (PROMIS) short form to evaluate the impact of the intervention on self-efficacy
  • System Outcomes - Impact of the intervention on incidence of emergency department visits and hospitalizations (ED+H) from administrative data.
  • System Outcomes - Impact of the intervention on resource utilization (acute care visits and use of supportive care) from administrative data.
  • Implementation Outcomes - Fidelity of the intervention
  • Implementation Outcomes - Patient adherence to the intervention
  • Implementation Outcomes - Provider adoption of the intervention
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.

Voir cet essai sur ClinicalTrials.gov

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