Clinical trial NCT07024329: Implementing REmote SymPtom mOnitoring and maNagement (RESPONd)
Official title: Implementing REmote SymPtom mOnitoring and maNagement (RESPONd): Evaluating the Impact on Cancer Patients, System Efficiency, and Economic Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Patient Reported Outcomes
Quality of Life
Clinical Decision Making
Patient Reported Outcome Measures
Patient Experience
Health Service Utilization
Symptom Management
PROMs
PROs
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Alberta Innovates Health Solutions
First posted: 2025-06-17
Enrollment: 1055
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Have cancer
* Receiving care in one of the participating clinics.
* Able to sign up for MyAHS Connect and consent.
* Have access to a digital device at home
* Able to complete their electronic PROs questionnaire without support from the clinic team on a weekly (patients on active treatment) or monthly (patients on follow-up) basis, for the duration of the intervention or until they are discharged from the clinic.
* Regular access to a telephone in order for the study nurse to call patients to provide symptom management support.

Exclusion Criteria:

* Patients with cognitive disabilities or who cannot reliably report symptoms independently.
* Patients not residing in Alberta, as government-issued ID is required to register for MyAHS Connect.
* Patients who do not have regular access to a telephone, as the study nurse needs to be able to call patients to provide symptom management support.
* Patients who do not speak English, or who do not have an English-speaking friend, family member, or caregiver to assist them, as the electronic PROs questionnaire is only available in English at this time.

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: Baseline, 3 months and 6 months
measure: Self-rated health
timeFrame: Baseline, 3 months and 6 months
measure: Rate of Emergency department (ED) visits
timeFrame: Baseline through study completion, an average of 18 months
measure: Rate of Hospital admissions
timeFrame: Baseline through study completion, an average of 18 months
measure: Economic outcome measure - Incremental cost-effectiveness ratio (ICER)
timeFrame: Baseline through study completion, an average of 18 months
measure: Economic outcome measures - Quality adjusted life years (QUALYs)
timeFrame: Baseline through study completion, an average of 18 months
Secondary outcomes:
measure: Clinic outcome measure - Patient scheduling and clinic visit type
timeFrame: Baseline through study completion, an average of 18 months
measure: Clinic outcome measure - Number of patients that required additional intervention
timeFrame: Baseline through study completion, an average of 18 months
measure: Clinic outcome measure - Number of times the study nurse needed to contact the Medical Oncologist
timeFrame: Baseline through study completion, an average of 18 months
measure: Patient experience measure
timeFrame: At baseline, and 6 months/end of the intervention
measure: Staff experience measure
timeFrame: Quarterly - from baseline through study completion, an average of 18 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Arthur J. E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: High River
country: Canada
facility: High River Community Cancer Centre
state: Alberta
city: Red Deer
country: Canada
facility: Central Alberta Cancer Centre
state: Alberta
Study officials:
affiliation: Cancer Care Alberta, Alberta Health Services
name: Linda Watson, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Care Alberta, Alberta Health Services
name: Marni Armstrong, PhD
role: STUDY_DIRECTOR
References:
citation: Watson L, Qi S, Link C, DeIure A, Afzal A, Barbera L. Patient-Reported Symptom Complexity and Acute Care Utilization Among Patients With Cancer: A Population-Based Study Using a Novel Symptom Complexity Algorithm and Observational Data. J Natl Compr Canc Netw. 2023 Feb;21(2):173-180. doi: 10.6004/jnccn.2022.7087.