NCT Number: NCT07024329
The goal of this study is to understand if the implementation of a remote symptom monitoring and management program improves outcomes. The program will provide patients the opportunity to complete electronic Patient Reported Outcomes (PROs) questionnaires from home between appointments and receive tailored advice from a study nurse. A second goal of this study is to examine the impact of electronic symptom monitoring on clinic efficiencies.
The main question it aims to answer is:
• What impact does implementing digitally enabled remote symptom monitoring and management (RESPONd) between ambulatory oncology visits have on patient outcomes and system efficiencies?
Participants will:
* Report their symptoms and concerns from home by completing the electronic symptom monitoring questionnaire. * Discuss their symptoms and concerns with a study nurse. * Provide feedback about their experience at important timepoints during the study. * Participate as usual in ambulatory clinic appointments.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Arthur J. E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
Rationale:
In recent years, cancer care has increasingly shifted from acute to ambulatory settings as a strategy to manage healthcare costs. While some emergency department (ED) visits are unavoidable due to the complexity of cancer-related issues, many could be prevented through timely symptom management and coordinated care in ambulatory oncology. The integration of Patient Reported Outcomes (PROs) into routine cancer care has been shown to reduce ED visits, enhance quality of life, and improve overall survival.
Within Cancer Care Alberta, PROs are routinely collected during clinic visits and electronically, using a standardized questionnaire that assesses common symptoms and supportive care needs experienced by cancer patients. Despite this, the use of electronic PROs data for real-time symptom management remains inconsistent, and there is currently no established workflow in Alberta for remote symptom monitoring. As a result, healthcare providers often lack advance insight into patients' symptoms prior to appointments.
Study Design:
The study is a stepped-wedge effectiveness-implementation type 1 hybrid design. RESPONd will be implemented over 1.5 years in six clinics, spanning tertiary, regional, and community cancer centres. Study nurses will monitor electronic PROs questionnaires completed between clinic visits and contact patients to provide personalized support. Collected electronic PROs information will also be utilized during weekly triage discussions in each clinic, where the route of care will be tailored for patients based on their symptom complexity. Participant quality of life will be measured at baseline, 3, and 6 months. Health care utilization compared to non-RESPONd patients will be evaluated. The implementation of this study will be evaluated using the RE-AIM framework, utilizing all constructs.
Following completion of the quantitative phase (stepped-wedge effectiveness-implementation type 1 hybrid design), a qualitative component will be conducted using semi-structured interviews with a subset of participants. This phase aims to explain and provide deeper insight into the quantitative results, including patient experiences, contextual factors influencing implementation, and perceived barriers and facilitators to intervention uptake.
Potential impact on practice:
The study will explore a person-centered, proactive approach to remote symptom management and the effects on patient experience, outcomes, and clinical teams. RESPONd represents an innovative opportunity to shift the model of care in oncology clinics to optimize efficiency and utilization of limited clinic resources and create a responsive care team that is ready and able to provide personalized symptom management and supportive care within the cancer journey.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A study nurse will digitally monitor symptom complexity and provide symptom management between clinic visits. This will increase the frequency of collection and use of electronic PROs to provide responsive symptom management. Electronic PROs are collected digitally, and a complexity algorithm is used to flag patients with high symptom complexity. This will allow the study nurse to proactively manage symptoms in a timelier way.
Support will be provided to clinic teams to implement a team huddle (team planning session) one week prior to clinics, to assess how additional electronic PROs data for patients participating in RESPONd impacts their ability to identify stable patients with low symptom complexity who could receive virtual care or Registered Nurse (RN) led clinic care.
Time frame: Baseline, 3 months and 6 months
RESPONd participants will be asked to complete the Euro Quality of Life -EuroQol-5 Dimension 5 Level (EQ-5D-5L) questionnaire. This is a generic measure of QoL often used with cancer patients. Consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with 5 levels (from no problems to extreme problems).
The responses form a 5-digit health state profile (e.g., 11111 = perfect health).
These profiles are converted into a single summary index value (utility score) using a Canadian-specific value set derived through the Time Trade-Off (TTO) method.
Utility Index Score Range (Canada):
Minimum: Less than 0 (indicating a health state considered worse than death) Maximum: 1 (indicating full or perfect health)
Time frame: Baseline, 3 months and 6 months
RESPONd participants will also be asked to complete the Euro Quality of Life (EuroQol) Visual Analog Scale (EQ-VAS) which assesses self-rated health on a vertical scale where respondents rate their overall health on the day of the survey.
Range: 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: Baseline through study completion, an average of 18 months
Frequency of ED usage rate per patient and per 1000
Time frame: Baseline through study completion, an average of 18 months
This will be measured by calculating number of inpatient stays per 1,000 people
Time frame: Baseline through study completion, an average of 18 months
The ICER ratio assesses cost-effectiveness and provides an estimate of the incremental cost for one additional unit of health outcome. To assess the effectiveness of the intervention, the ICER ratio per ED visit and hospital admission avoided will be applied to assess the number of visits avoided due to RESPONd. The number of ED visits and hospital admissions are also included as these are required to calculate the ICER ratio per visit type avoided.
Time frame: Baseline through study completion, an average of 18 months
Quality adjusted life years (QUALYs): A quality-adjusted life year is a summary measure used to evaluate the value of medical interventions in terms of the quality and quantity of life they produce. It combines both the duration of life and the health-related quality of life into a single index number. ICERs and net monetary benefit will be used to report QUALYs.
Time frame: Baseline through study completion, an average of 18 months
Information on the number, length, and type of visit (in-person or virtual; portal, telephone, email, or Zoom; Registered Nurse-led (RN-led) or Medical Oncologist-led (MO-led) will be obtained from the administrative database to assess clinical efficiency.
Time frame: Baseline through study completion, an average of 18 months
The number of patients that required additional intervention after a clinic visit to determine if the triaged care was sufficient. The study nurse will also be required to keep track of the number of times needed to contact the medical oncologist (MO) address out of scope matters to also assess clinical efficiency.
Time frame: Baseline through study completion, an average of 18 months
The study nurse will keep track of the number of times needed to contact the Medical Oncologist (MO) to address out of scope matters to assess clinical efficiency.
Time frame: At baseline, and 6 months/end of the intervention
To understand patient perspectives, a web-based questionnaire will be disseminated to RESPONd participants via REDCap. Thirteen items on the patient experience measure are adapted from the Your Voice Matters patient-reported experience measure, developed by Cancer Care Ontario. Participants will be asked to rate each care experience using a three-point Likert scale:
One question asks participants to measure the overall quality of all of their cancer care in the past 6 months using a five-point Likert scale:
Time frame: Quarterly - from baseline through study completion, an average of 18 months
A researcher-developed web-based questionnaire designed to capture feedback from oncology clinic staff on the implementation and impact of the RESPONd program and the weekly team huddle.
It includes questions on staff roles, clinic location, and perceived impacts on team collaboration, workflow efficiency, and the integration of patient data such as electronic PROs. The survey specifically evaluates how having access to weekly electronic PROs and participating in structured team huddles affects clinical decision-making and communication.
Oncology clinic staff will be asked to rate each experience using a four-point Likert scale:
Contact information is provided by the study sponsor or research team.
Benedicta Asante, RSW, MSW
CONTACT
Chizoba Anyimukwu, MPH, DrPH
CONTACT
University of Calgary
Other
Implementing REmote SymPtom mOnitoring and maNagement (RESPONd): Evaluating the Impact on Cancer Patients, System Efficiency, and Economic Outcomes
Acronym: RESPONd
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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