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

NCT ID: NCT03849950

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2020-09-28

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.

Conditions

Lymphoma; Lung Cancer; Colo-rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SMARTCare

1. Training in self-management support (SMS) strategies for ambulatory nursing staff

2. A web-based self-management education (I-Can-Manage Cancer) for patients

3. Telephone-based, nurse-led health coaching

4. Optional end of study patient interview (sub-study)

Group Type: EXPERIMENTAL

SMARTCare

Intervention Type: OTHER

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.

Control

1\. Training in self-management support (SMS) strategies for ambulatory nursing staff

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Care Ontario

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Krzyzanowska, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Doris Howell, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

Howell D, Pond GR, Bryant-Lukosius D, Powis M, McGowan PT, Makuwaza T, Kukreti V, Rask S, Hack S, Krzyzanowska MK. Feasibility and Effectiveness of Self-Management Education and Coaching on Patient Activation for Managing Cancer Treatment Toxicities. J Natl Compr Canc Netw. 2023 Mar;21(3):247-256.e8. doi: 10.6004/jnccn.2022.7095.

Reference Type: DERIVED

PMID: 36898363 (View on PubMed)

Other Identifiers

2018-SMARTCare-001

Identifier Type: -

Identifier Source: org_study_id