Clinical trial NCT03849950: Self-Management and Activation to Reduce Treatment-Related Toxicities (SMARTCare)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphoma
Lung Cancer
Colo-rectal Cancer
Keywords: self-management support
health coaching
patient education
treatment-related toxicities
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Cancer Care Ontario
First posted: 2019-02-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of lymphoma (Hodgkin's or non-Hodgkin's), colorectal, or lung cancer.
* Initiating adjuvant or first-line metastatic treatment with oral or systemic therapy within the accrual period at a participating centre. Patients receiving treatment with immunotherapy are eligible to participate.
* Eastern Cooperative Oncology Group (ECOG) \</=2.
* Ability to understand and provide written informed consent.
* Access to an electronic device and internet connection to allow the participant to access the web-based I-Can-Manage Cancer education modules.
* Language and literacy skills consistent with completing validated questionnaires, and willingness to complete questionnaires as required.

Exclusion Criteria:

* Currently participating in a clinical trial involving receipt of an investigational agent.

Primary outcomes:
measure: Reasons for non-participation
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: Reasons for premature discontinuation or withdrawal
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: Recruitment rate
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: Retention rate
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: Usage of I-Can-Manage (intervention arm only)
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: 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.
timeFrame: Assessed at 4-6 months post first dose +/- 2 weeks
Secondary outcomes:
measure: Patient Outcomes - Memorial Symptom Assessment Scale - Short Form (MSAS-SF) to evaluate the impact of the intervention on symptom control
timeFrame: Assessed at 2, 4 and 6 months post first dose +/- 2 weeks
measure: Patient Outcomes - EQ-5D-5L to evaluate the impact of the intervention on health-related quality of life
timeFrame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks
measure: Patient Outcomes - Hospital Anxiety and Depression Scale (HADS) to assess psychological distress
timeFrame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks
measure: Patient Outcomes - Patient Activation Measure (PAM) to evaluate the impact of the intervention on patient activation
timeFrame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks
measure: Patient Outcomes - Patient Reported Outcomes Measurement Information System (PROMIS) short form to evaluate the impact of the intervention on self-efficacy
timeFrame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks
measure: System Outcomes - Impact of the intervention on incidence of emergency department visits and hospitalizations (ED+H) from administrative data.
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: System Outcomes - Impact of the intervention on resource utilization (acute care visits and use of supportive care) from administrative data.
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: Implementation Outcomes - Fidelity of the intervention
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: Implementation Outcomes - Patient adherence to the intervention
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
measure: Implementation Outcomes - Provider adoption of the intervention
timeFrame: Assessed at baseline to 6 months post first dose +/- 2 weeks
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Monika Krzyzanowska, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Doris Howell, PhD
role: PRINCIPAL_INVESTIGATOR
References: