Implementing REmote SymPtom mOnitoring and maNagement (RESPONd)

NCT07024329 | Recruiting

• 1 other identifier: HREBA.CC-24-0138
• Study Type: interventional
• Target: 1,055
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (6)

• Quality of Life (QoL)

  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)

  Baseline, 3 months and 6 months

• Self-rated health

  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).

  Baseline, 3 months and 6 months

• Rate of Emergency department (ED) visits

  Frequency of ED usage rate per patient and per 1000

  Baseline through study completion, an average of 18 months

• Rate of Hospital admissions

  This will be measured by calculating number of inpatient stays per 1,000 people

  Baseline through study completion, an average of 18 months

• Economic outcome measure - Incremental cost-effectiveness ratio (ICER)

  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.

  Baseline through study completion, an average of 18 months

• Economic outcome measures - Quality adjusted life years (QUALYs)

  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.

  Baseline through study completion, an average of 18 months

Secondary Outcomes (5)

• Clinic outcome measure - Patient scheduling and clinic visit type

  Baseline through study completion, an average of 18 months

• Clinic outcome measure - Number of patients that required additional intervention

  Baseline through study completion, an average of 18 months

• Clinic outcome measure - Number of times the study nurse needed to contact the Medical Oncologist

  Baseline through study completion, an average of 18 months

• Patient experience measure

  At baseline, and 6 months/end of the intervention

• Staff experience measure

  Quarterly - from baseline through study completion, an average of 18 months

Study Arms (2)

RESPONd

EXPERIMENTAL

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.

Other: Remote Symptom Monitoring and Management; Other: Clinic Team Huddle

Non-RESPONd

NO INTERVENTION

Usual care.

Interventions

Remote Symptom Monitoring and Management 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.

RESPONd

Clinic Team Huddle 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.

RESPONd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator
• Alberta Innovates Health Solutions: collaborator

Study Sites (4)

Arthur J. E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

High River Community Cancer Centre

High River, Alberta, T1V 1B3, Canada

NOT YET RECRUITING

Central Alberta Cancer Centre

Red Deer, Alberta, T4N 6R2, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 36791760 RESULT

MeSH Terms

Conditions

Neoplasms; Patient Acceptance of Health Care

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Linda Watson, RN, PhD

  Cancer Care Alberta, Alberta Health Services

  PRINCIPAL INVESTIGATOR

• Marni Armstrong, PhD

  Cancer Care Alberta, Alberta Health Services

  STUDY DIRECTOR

Central Study Contacts

Chizoba Anyimukwu, MPH, DrPH

CONTACT

587-943-3556; chizoba.anyimukwu@albertahealthservices.ca

Benedicta Asante, RSW, MSW

CONTACT

587-943-3562; benedicta.asante@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director, Supportive Care Services and Patient Experience, Cancer Care Alberta, Alberta Health Services

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 17, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)