LymphomaNCT03849950
Self-Management and Activation to Reduce Treatment-Related Toxicities (SMARTCare)
A study testing SMARTCare in people with Lymphoma and Lung Cancer, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lung Cancer, Colo-rectal Cancer
- What is being tested?
- SMARTCare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesCanada
- Study dates
- 11 Jun 2019to 28 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently participating in a clinical trial involving receipt of an investigational agent.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M6M2
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8V5C2
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
About this study
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)
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.
Read the 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
- Being tested
- SMARTCare, Control
- Keywords
- self-management support, health coaching, patient education, treatment-related toxicities
- Medical subject headings
- Lymphoma, Lung Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTCareOther
- Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care.
- 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.
- 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.
- Optional sub-study: A sub-set of patients will participate in an end of study interview to gain further insight into SMARTCare.
ControlOther
- Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: SMARTCare |
| Control | Active comparator | 1. Training in self-management support (SMS) strategies for ambulatory nursing staff Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at baseline and 2, 4 and 6 months post first dose +/- 2 weeks
System Outcomes - Impact of the intervention on incidence of emergency department visits and hospitalizations (ED+H) from administrative data.
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.
Measured: Assessed at baseline to 6 months post first dose +/- 2 weeks
System Outcomes - Impact of the intervention on resource utilization (acute care visits and use of supportive care) from administrative data.
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.
Measured: Assessed at baseline to 6 months post first dose +/- 2 weeks
Implementation Outcomes - Fidelity of the intervention
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.
Measured: Assessed at baseline to 6 months post first dose +/- 2 weeks
Implementation Outcomes - Patient adherence to the intervention
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.
Measured: Assessed at baseline to 6 months post first dose +/- 2 weeks
Implementation Outcomes - Provider adoption of the intervention
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.
Measured: Assessed at baseline to 6 months post first dose +/- 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start11 Jun 2019
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Why it stopped: Recruitment was halted prematurely due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Care Ontario
- Responsible party
- Sponsor
- Investigators
- Monika Krzyzanowska, MD MPH, Principal investigator, University Health Network, TorontoDoris Howell, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849950
- Sponsor's protocol ID
- 2018-SMARTCare-001
- Status last verified
- Sep 2021
- First submitted
- 25 Jan 2019
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36898363
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03849950
- Acronym / sponsor ID
- 2018-SMARTCare-001
- Conditions
- Lymphoma, Lung Cancer, Colo-rectal Cancer
- Keywords
- self-management support, health coaching, patient education, treatment-related toxicities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was halted prematurely due to the COVID-19 pandemic.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Cancer Care Ontario
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMARTCare | Experimental | Other: SMARTCare1. 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) |
| Control | Active comparator | Other: Control1. Training in self-management support (SMS) strategies for ambulatory nursing staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Currently participating in a clinical trial involving receipt of an investigational agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMARTCare1. 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. | Other | SMARTCare |
| Control1. Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care. | Other | Control |
Primary outcome
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.
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.
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.
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.
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.
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.
10 secondary outcomes
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 - 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 - 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 - 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 - 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
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
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
Implementation Outcomes - Fidelity of the intervention
Time frame: Assessed at baseline to 6 months post first dose +/- 2 weeks
Implementation Outcomes - Patient adherence to the intervention
Time frame: Assessed at baseline to 6 months post first dose +/- 2 weeks
Implementation Outcomes - Provider adoption of the intervention
Time frame: Assessed at baseline to 6 months post first dose +/- 2 weeks
Results and safety
The study was stopped early (reason given: Recruitment was halted prematurely due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 36898363Howell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Krzyzanowska, MD MPH principal investigator
University Health Network, Toronto
Doris Howell, PhD principal investigator
University Health Network, Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMARTCare in people with Lymphoma and Lung Cancer, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was halted prematurely due to the COVID-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reasons for non-participation (time frame: Assessed at baseline to 6 months post first dose +/- 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.