Remote Symptom Monitoring for Cancer

(RESPONd Trial)

Recruiting at 3 trial locations

Overseen By Chizoba Anyimukwu, MPH, DrPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Cognitive disabilities, Non-Alberta residents, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1055 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a digital program for monitoring cancer symptoms from home can improve patient care and clinic efficiency. Participants will complete electronic questionnaires about their symptoms and discuss them with a study nurse, all from home. Individuals with cancer who are actively receiving treatment and can use digital devices for weekly or monthly check-ins may be suitable candidates. The trial aims to determine if this remote monitoring approach, called RESPONd, helps patients feel better and streamlines clinic visits. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance cancer care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring symptoms remotely, so you may not need to change your medication routine.

What prior data suggests that this remote symptom monitoring program is safe?

Research has shown that remote symptom monitoring, such as the RESPONd program, is generally safe for patients. Studies have found that electronic tools for reporting symptoms can effectively manage them. For instance, tracking symptoms in this way has reduced hospital visits and helped patients manage treatment side effects. This indicates it is well-tolerated and poses little risk.

In the RESPONd program, patients report symptoms from home and receive advice from a nurse. No reports of serious negative effects have emerged from using this type of digital symptom tracking. Instead, it has demonstrated benefits, such as improving the quality of care. While the main focus isn't on side effects, evidence suggests that this kind of program is a safe option for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RESPONd trial because it introduces a new way of managing cancer symptoms remotely. Unlike usual care, which typically involves in-person monitoring of symptoms during clinic visits, RESPONd uses electronic patient-reported outcomes (PROs) questionnaires completed by patients at home. Study nurses then monitor these responses between visits and offer personalized support, potentially improving communication and response times. This method could pave the way for more proactive and tailored care, making it a promising addition to cancer management strategies.

What evidence suggests that the RESPONd program is effective for remote symptom monitoring in cancer patients?

Research shows that tracking symptoms from home can greatly enhance the lives of cancer patients. A review of several studies found that this method significantly improved the well-being of people with lung cancer. Additionally, patients using remote monitoring had fewer hospital visits. Compared to regular care, remote tracking reduced physical symptoms and improved overall quality of life during cancer treatment. In this trial, participants in the RESPONd arm will use online questionnaires and receive personalized advice from nurses, potentially managing cancer symptoms effectively at home. ^{6 7 8 9 10}

Who Is on the Research Team?

Linda Watson, RN, PhD

Principal Investigator

Cancer Care Alberta, Alberta Health Services

Marni Armstrong, PhD

Principal Investigator

Cancer Care Alberta, Alberta Health Services

Are You a Good Fit for This Trial?

This trial is for cancer patients who are currently receiving outpatient care. Participants should be comfortable using digital tools to report symptoms from home and willing to discuss these with a study nurse. They must also be able to provide feedback during the study.

Inclusion Criteria

Have access to a digital device at home

I am 18 years old or older.

Receiving care in one of the participating clinics

Exclusion Criteria

Patients not residing in Alberta

Patients who do not have regular access to a telephone

I have cognitive disabilities that affect my ability to report symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the RESPONd program where participants complete electronic PROs questionnaires and receive tailored advice from a study nurse.

18 months

Remote monitoring with regular contact from study nurses

Follow-up

Participants are monitored for safety and effectiveness after the implementation of the RESPONd program.

6 months

Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

• RESPONd

Trial Overview The RESPONd program is being tested, which involves patients reporting their symptoms electronically between clinic visits and getting advice from nurses based on their inputs. The study aims to see if this improves patient outcomes and clinic efficiency.

How Is the Trial Designed?

Group I: RESPONd Experimental Treatment 2 Interventions

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 II: Non-RESPONd Active Control 1 Intervention

Usual care.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Alberta Innovates Health Solutions

Collaborator

Trials

54

Recruited

94,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223247/

Effectiveness of symptom monitoring on electronic patient ... The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833891

Remote Symptom Monitoring With Electronic Patient ... This nonrandomized controlled trial found that RSM implementation was associated with reduced risk of hospitalizations for patients with cancer.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208123001171

Effects of Patient-Reported Outcome Tracking and Health ... Compared to standard care, remote patient monitoring via RPMS was related to greater quality of life and lower physical symptom burden during cancer therapy.

4. pcori.org pcori.org/research-results/2016/comparing-effectiveness-electronic-symptom-monitoring-versus-usual-care-improving-survival-among-patients-metastatic-cancer-pro-tect-trial

The PRO-TECT Trial In this study, the research team compared use of a weekly electronic symptom tracking system versus usual care for patients with cancer.

5. trialx.com trialx.com/clinical-trials/listings/299315/implementing-remote-symptom-monitoring-and-management-respond/?&radius=10&place=Putzu&user_country=Taiwan

Implementing REmote SymPtom mOnitoring and ... The program will provide patients the opportunity to complete electronic Patient Reported Outcomes (PROs) questionnaires from home between ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12076171/

Remote Symptom Monitoring With Electronic Patient ... What is the association of electronic patient-reported outcome-based remote symptom monitoring (RSM) with health care utilization in patients with cancer?

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07024329

Implementing REmote SymPtom mOnitoring and ... The goal of this study is to understand if the implementation of a remote symptom monitoring and management program improves outcomes.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208125000944

Integrating Remote Symptom Monitoring, Person-Centered ... Several remote symptom monitoring interventions have demonstrated potential to reduce disease- and treatment-related symptom burden and improve health outcomes ...

9. ascopubs.org ascopubs.org/doi/10.1200/CCI.23.00182

Impact of Remote Symptom Monitoring With Electronic ... Symptom monitoring with ePROs improved quality and value of cancer care delivery by reducing hospitalizations, emergency visits, and deaths ...

10. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/news/grand-rounds-march-17-2023-remote-symptom-monitoring-with-electronic-patient-reported-outcomes-epros-in-oncology-ethan-basch-md-msc/

Remote Symptom Monitoring with Electronic Patient ... Symptom monitoring enables control of chemotherapy side effects, enabling more intensive and longer duration of cancer treatment. The PRO-TECT ...