Implementing REmote SymPtom mOnitoring and maNagement (RESPONd)

NCT ID: NCT07024329

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1055 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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RESPONd

Participants will be recruited and supported to complete electronic PROs questionnaires. Study nurses will monitor the electronic PROs completed between clinic visits and contact patients to provide personalized support.

Group Type EXPERIMENTAL

Remote Symptom Monitoring and Management

Intervention Type OTHER

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.

Clinic Team Huddle

Intervention Type OTHER

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.

Non-RESPONd

Usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote Symptom Monitoring and Management

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.

Intervention Type OTHER

Clinic Team Huddle

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Health services

OTHER

Sponsor Role collaborator

Alberta Innovates Health Solutions

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Linda Watson

Executive Director, Supportive Care Services and Patient Experience, Cancer Care Alberta, Alberta Health Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linda Watson, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Care Alberta, Alberta Health Services

Marni Armstrong, PhD

Role: STUDY_DIRECTOR

Cancer Care Alberta, Alberta Health Services

Locations

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Arthur J. E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Site Status NOT_YET_RECRUITING

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

High River Community Cancer Centre

High River, Alberta, Canada

Site Status NOT_YET_RECRUITING

Central Alberta Cancer Centre

Red Deer, Alberta, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Chizoba Anyimukwu, MPH, DrPH

Role: CONTACT

587-943-3556

Benedicta Asante, RSW, MSW

Role: CONTACT

587-943-3562

Facility Contacts

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Chizoba Anyimukwu

Role: primary

587-943-3556

Chizoba Anyimukwu

Role: primary

587-943-3556

Chizoba Anyimukwu

Role: primary

587-943-3556

Chizoba Anyimukwu

Role: primary

587-943-3556

References

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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.

Reference Type BACKGROUND
PMID: 36791760 (View on PubMed)

Other Identifiers

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HREBA.CC-24-0138

Identifier Type: -

Identifier Source: org_study_id

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