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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849950
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Lymphoma Lung Cancer Colo-rectal Cancer Other: SMARTCare Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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)
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Other: 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.

Active Comparator: Control
1. Training in self-management support (SMS) strategies for ambulatory nursing staff
Other: Control
1. Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care.




Primary Outcome Measures :
  1. Reasons for non-participation [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    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.

  2. Reasons for premature discontinuation or withdrawal [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    Reasons for premature discontinuation or withdrawal will be captured in MedidataRAVE and evaluated as one aspect of feasibility.

  3. Recruitment rate [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    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.

  4. Retention rate [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    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.

  5. Usage of I-Can-Manage (intervention arm only) [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    Automated back-end analytics will be utilized to track patterns of usage of the I-Can-Manage Cancer Education Modules.

  6. 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. [ Time Frame: Assessed at 4-6 months post first dose +/- 2 weeks ]

    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.



Secondary Outcome Measures :
  1. Patient Outcomes - Memorial Symptom Assessment Scale - Short Form (MSAS-SF) to evaluate the impact of the intervention on symptom control [ Time Frame: Assessed at 2, 4 and 6 months post first dose +/- 2 weeks ]
    Patient outcomes will be evaluated using a series of questionnaires. To evaluate symptom control, the Memorial Symptom Assessment Scale - Short Form (MSAS-SF) will be administered. The MSAS-SF consists of a list of symptoms that patients answer "yes/no" to if they have experienced them in the past week. For symptoms answered yes, patients rate how much the symptom distressed or bothered them on a scale ranging from "Not at all (0)" to "Very Much (4)". The inclusion of this measure will allow the investigators and the study team to determine the best measure(s) to use as primary endpoint in the definitive trial.

  2. Patient Outcomes - EQ-5D-5L to evaluate the impact of the intervention on health-related quality of life [ Time Frame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks ]
    Patient outcomes will be evaluated using a series of questionnaires. To evaluate health-related quality of life, the EQ-5D-5L will be administered. The EQ-5D-5L consists of a series of headings with statements listed below. Patients are asked to select a box that best describes their health that day from a list of statements respective of each heading. The questionnaire also asks how good or bad their health is that day with 0 being the worst health a patient can imagine and 100 being the best health. The inclusion of this measure will allow the investigators and the study team to determine the best measure(s) to use as primary endpoint in the definitive trial.

  3. Patient Outcomes - Hospital Anxiety and Depression Scale (HADS) to assess psychological distress [ Time Frame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks ]
    Patient outcomes will be evaluated using a series of questionnaires. To evaluate psychological distress, the HADS will be administered. The HADS consists of different statements that patients are asked to respond to using a scale ranging from "Not at All (0)" to "Most of the time (3)". The inclusion of this measure will allow the investigators and the study team to determine the best measure(s) to use as primary endpoint in the definitive trial.

  4. Patient Outcomes - Patient Activation Measure (PAM) to evaluate the impact of the intervention on patient activation [ Time Frame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks ]
    Patient outcomes will be evaluated using a series of questionnaires. To evaluate patient activation, the PAM will be administered. The PAM consists of different statement that people sometimes make when they talk about their health. Patients are asked to respond to these statements using a scale ranging from "Disagree Strongly" to "Agree Strongly", or "N/A". The inclusion of this measure will allow the investigators and the study team to determine the best measure(s) to use as primary endpoint in the definitive trial.

  5. Patient Outcomes - Patient Reported Outcomes Measurement Information System (PROMIS) short form to evaluate the impact of the intervention on self-efficacy [ Time Frame: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks ]
    Patient outcomes will be evaluated using a series of questionnaires. To evaluate self-efficacy, the PROMIS will be administered. The PROMIS consists of different self-efficacy confidence statements that patients are asked to respond to using a scale ranging from "I am not at all confident (1)" to "I am very confident (5)". The inclusion of this measure will allow the investigators and the study team to determine the best measure(s) to use as primary endpoint in the definitive trial.

  6. System Outcomes - Impact of the intervention on incidence of emergency department visits and hospitalizations (ED+H) from administrative data. [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]

    Emergency department visits and hospitalizations (ED+H) will be assessed using administrative data by linking patient-level data from the study to provincial administrative data using OHIP numbers.

    Information on drugs received, dates of treatment and institution where treatment was given will be identified from the Activity Level Reporting (ALR) database. The Ontario Cancer Registry (OCR) and the Collaborative Stage Database (CSD) will be used to confirm the patient has lymphoma, colorectal or lung cancer, as well as staging information. The National Ambulatory Care Reporting System (NACRS) database and Canadian Institutes for Health Information Discharge Abstract Database (CIHI-DAD) will be used to obtain information on ED visits and hospitalizations, respectively. All data analysis using healthcare administrative data will be completed at Cancer Care Ontario.


  7. System Outcomes - Impact of the intervention on resource utilization (acute care visits and use of supportive care) from administrative data. [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]

    Resource utilization will be compared between control and intervention arms using administrative data by linking patient-level data from the study to provincial administrative data using OHIP numbers.

    Information on drugs received, dates of treatment and institution where treatment was given will be identified from the Activity Level Reporting (ALR) database. The Ontario Cancer Registry (OCR) and the Collaborative Stage Database (CSD) will be used to confirm the patient has lymphoma, colorectal or lung cancer, as well as staging information. The National Ambulatory Care Reporting System (NACRS) database and Canadian Institutes for Health Information Discharge Abstract Database (CIHI-DAD) will be used to obtain information on ED visits and hospitalizations, respectively. All data analysis using healthcare administrative data will be completed at Cancer Care Ontario.


  8. Implementation Outcomes - Fidelity of the intervention [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    Members of the steering committee with expertise in health coaching will conduct two unannounced drop-in sessions at each of the participating centres to evaluate the content of the coaching calls, and health coaching reporting form documentation using a standardized evaluation form to take contemporaneous notes.

  9. Implementation Outcomes - Patient adherence to the intervention [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    The proportion of calls delivered per protocol, based on information entered into MedidataRAVE will be calculated for each patient. Computerized back-end analytics will be used to capture how and when aspects of the I-Can-Manage Cancer Education Modules are accessed to evaluate patterns of usage.

  10. Implementation Outcomes - Provider adoption of the intervention [ Time Frame: Assessed at baseline to 6 months post first dose +/- 2 weeks ]
    Uptake of self-management support strategies will be analyzed using anonymous pre- and post-training evaluation form. Field notes will be used to track monthly meetings with participating cancer centres to summarize issues in implementation, and to inform mid-course correction to facilitate adoption of SMARTCare.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849950


Contacts
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Contact: Melanie Powis, MSc 4169464501 ext 4789 melanie.powis@uhn.ca
Contact: Ryan Kirkby, BSc 4169464501 ext 4789 ryan.kirkby@uhn.ca

Locations
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Canada, Ontario
Royal Victoria Regional Health Centre Not yet recruiting
Barrie, Ontario, Canada, L4M6M2
Contact: Christine Di Marco, BSc         
Principal Investigator: Sara Rask, MD         
Hamilton Health Sciences Corporation Recruiting
Hamilton, Ontario, Canada, L8V5C2
Contact: Sarah Rietkoetter, BA BHSc    9053879711 ext 67702    rietkos@mcmaster.ca   
Contact: Laurel Person    9053879711 ext 67707    personml@mcmaster.ca   
Principal Investigator: Denise Bryant-Lukosius, PhD MScN         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Melanie Powis, MSc         
Principal Investigator: Monika Krzyzanowska, MD MPH         
Principal Investigator: Doris Howell, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Cancer Care Ontario
Investigators
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Principal Investigator: Monika Krzyzanowska, MD MPH University Health Network, Toronto
Principal Investigator: Doris Howell, PhD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03849950    
Other Study ID Numbers: 2018-SMARTCare-001
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
self-management support
health coaching
patient education
treatment-related toxicities
Additional relevant MeSH terms:
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Lymphoma
Lung Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases