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

NCT03849950 | Terminated

• 1 other identifier: 2018-SMARTCare-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphoma; Lung Cancer; Colo-rectal Cancer

Keywords

self-management support; health coaching; patient education; treatment-related toxicities

Outcome Measures

Primary Outcomes (6)

• Reasons for non-participation

  Participating cancer centres will maintain Screening and Enrollment logs for the duration of the study. Reasons for non-participation will be documented on the logs and evaluated as one aspect of feasibility.

  Assessed at baseline to 6 months post first dose +/- 2 weeks

• Reasons for premature discontinuation or withdrawal

  Reasons for premature discontinuation or withdrawal will be captured in MedidataRAVE and evaluated as one aspect of feasibility.

  Assessed at baseline to 6 months post first dose +/- 2 weeks

• Recruitment rate

  Participating cancer centres will maintain Screening and Enrollment logs for the duration of the study. The logs will be used to calculate recruitment rates. The recruitment rate will be calculated as the proportion of patients that have agreed to participate among those approached and evaluated as one aspect of feasibility.

  Assessed at baseline to 6 months post first dose +/- 2 weeks

• Retention rate

  Retention rate will be calculated as the proportion of patients who did not prematurely discontinue or withdraw among those that consented to participate, and evaluated as one aspect of feasibility.

  Assessed at baseline to 6 months post first dose +/- 2 weeks

• Usage of I-Can-Manage (intervention arm only)

  Automated back-end analytics will be utilized to track patterns of usage of the I-Can-Manage Cancer Education Modules.

  Assessed at baseline to 6 months post first dose +/- 2 weeks

• 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.

  Acceptability of the intervention to patients will be evaluated using the Intervention Acceptability Questionnaire that has been developed for the study. The 3-section questionnaire (I-Can-Manage Cancer Modules; Health Coaching Calls; Overall Acceptability) asks patients to rate agreement statements from "Disagree Strongly" to "Agree Strongly". Individual scores for each statement in each section will be recorded. Audio recorded end of study qualitative interviews (approximately 30 minutes) will be conducted by a member of the study steering committee. The interviewer will follow a SMARTCare Patient Interview Guide. The guide consists of open-ended questions focusing on: (1) access, use, content and utility of the I-Can-Manage Cancer Modules; (2) logistics/timing/dose, content and utility of Health Coaching; and (3) General Comments. Interview transcripts will be analyzed in NVIVO to identify common themes.

  Assessed at 4-6 months post first dose +/- 2 weeks

Secondary Outcomes (10)

• Patient Outcomes - Memorial Symptom Assessment Scale - Short Form (MSAS-SF) to evaluate the impact of the intervention on symptom control

  Assessed at 2, 4 and 6 months post first dose +/- 2 weeks

• Patient Outcomes - EQ-5D-5L to evaluate the impact of the intervention on health-related quality of life

  Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks

• Patient Outcomes - Hospital Anxiety and Depression Scale (HADS) to assess psychological distress

  Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks

• Patient Outcomes - Patient Activation Measure (PAM) to evaluate the impact of the intervention on patient activation

  Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks

• Patient Outcomes - Patient Reported Outcomes Measurement Information System (PROMIS) short form to evaluate the impact of the intervention on self-efficacy

  Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks

Study Arms (2)

SMARTCare

EXPERIMENTAL

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)

Other: SMARTCare

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

SMARTCare 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.

SMARTCare

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Cancer Care Ontario: collaborator

Study Sites (3)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M6M2, Canada

Location

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8V5C2, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 36898363 DERIVED

MeSH Terms

Conditions

Lymphoma; Lung Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Monika Krzyzanowska, MD MPH

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Doris Howell, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 21, 2019
• Study Start: June 11, 2019
• Primary Completion: September 28, 2020
• Study Completion: September 28, 2020
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)