200 Participants Needed

At-Home vs Clinic-Based Therapy for Advanced Cancer

Recruiting at 1 trial location
CT
RS
RS
Overseen ByRoxana S. Dronca, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mayo Clinic
Must be taking: Chemotherapy, Supportive care
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether receiving cancer treatment at home can improve the quality of life for patients with advanced cancer compared to traditional clinic visits. It aims to determine if home-based care can reduce stress and costs while maintaining treatment effectiveness. The trial includes patients with specific types of cancer, such as breast, lung, or prostate, who are already managing their treatment well and live in areas with reliable internet access for remote monitoring. Participants will either continue their treatment entirely at home (Home Health Encounter) or split it between the clinic (Clinical Encounter) and home. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. In fact, it allows for certain standard of care oral drugs and anti-hormonal agents to be taken alongside the trial treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that receiving cancer treatment at home can be as safe as receiving it in a clinic. For instance, home chemotherapy is a safe alternative to hospital care and helps patients adhere to their treatment plans more effectively. One study found that patients receiving care at home felt safe and satisfied, with fewer subsequent hospital visits.

For those treated in clinics, studies have not identified any major safety concerns. Patients with advanced cancer often visit urgent care clinics without encountering significant safety issues.

Overall, both at-home and clinic-based treatments are well-received, with patients reporting feelings of safety and satisfaction with both options.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a new approach to cancer care that blends at-home and clinic-based treatments. Unlike traditional cancer treatments that require frequent visits to the hospital, this approach allows patients to receive their standard of care treatments at home. For Arm A, patients continue their treatments at home for about 24 weeks with remote monitoring using biometric devices and video consultations with their care team. Arm B starts with 8 weeks of clinic-based treatment, followed by 16 weeks of home-based care, offering a gradual transition to at-home therapy. This flexibility could make cancer treatment more convenient and less stressful, potentially improving the quality of life for patients.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

This trial will compare at-home treatment with a combination of clinic and at-home treatment for advanced cancer. Research has shown that receiving cancer care at home can greatly improve a patient's quality of life. Patients treated at home often remain more active and have lower chances of dying or needing to return to the hospital compared to those treated in a hospital. One study found that 42.2% to 91% of patients avoided hospital readmission when they received care at home. Caregivers also reported feeling safe with home-based care. In contrast, treatments given in clinics can help manage symptoms but do not cure advanced cancer. These findings suggest that home-based care might provide a better overall experience for patients with advanced cancer.678910

Who Is on the Research Team?

RS

Roxana S. Dronca, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancer who live within 35 miles of the clinic, can handle their current chemo well, and plan to continue it for at least 24 weeks. They need Wi-Fi at home and must be able to fill out questionnaires. People needing constant help or on other treatments (except hormone therapy), with severe illnesses, recent serious infections, or unstable heart conditions cannot join.

Inclusion Criteria

I have been confirmed to tolerate standard chemotherapy well without any drug-related reactions.
Signed informed consent form by patient
Residence has Wi-Fi to enable a reliable connection with the remote Command Center
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Exclusion Criteria

I am not on any clinical trial drugs or standard treatments not approved for this study, except hormone therapy for breast or prostate cancer.
I have not had a severe infection or been hospitalized for one in the last 4 weeks.
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Patients receive at least 1 cycle of their standard of care chemotherapy regimen in the clinic

4 weeks

Randomized Treatment

Patients are randomized to receive chemotherapy either at home or in the clinic

24 weeks
Regular visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Clinical Encounter
  • Home Health Encounter
Trial Overview The study compares receiving cancer treatment at home versus in a clinic setting. It aims to see if home-based care reduces stress and improves compliance with treatment plans. Participants will receive either clinical encounters or home health visits along with quality-of-life assessments through questionnaires.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm B (clinic & at-home treatment)Experimental Treatment4 Interventions
Group II: Arm A (at-home treatment)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Published Research Related to This Trial

A project in the Onco Pays-de-la-Loire network successfully administered home-based chemotherapy to 41 cancer patients, with no major issues reported and only 1.9% of drug preparations destroyed.
The initiative not only improved patient care and satisfaction among healthcare professionals but also resulted in reduced costs for outpatient chemotherapy, highlighting the effectiveness of coordinated nursing and pharmaceutical efforts.
[Outpatient chemotherapy and oncology network : Onco Pays-de-la-Loire experiment].Lewden-Bernadac, B., Courant-Menanteau, M., Perrocheau, G., et al.[2022]
The hospital-at-home care program by ANT for advanced cancer patients has successfully treated 5,603 patients from 1985 to 1991, achieving a 70% rate of deaths occurring at home, which indicates a preference for home-based end-of-life care.
Pain control was effectively managed in 95% of cases, highlighting the program's efficacy in symptom management, while suggesting that eligibility for home care should consider not just medical status but also social and psychological factors.
The Bologna Eubiosia Project: hospital-at-home care for advanced cancer patients.Pannuti, F., Tanneberger, S.[2017]
In a study of 261 patients with advanced cancer undergoing chemotherapy, those who utilized home-based nursing services early during treatment were more likely to transition to home care after their last chemotherapy session, with a transfer rate of 17.5% compared to 7.2% in the control group.
The analysis indicated that early use of home-based nursing services significantly increased the odds of transferring to home care, with an odds ratio of 3.077, suggesting that timely nursing support can positively influence post-treatment care options.
Association of a home-based nursing service during chemotherapy with the transfer to home care immediately after the last chemotherapy treatment in patients with advanced cancer.Higashibata, T., Iwata, N., Kazama, I., et al.[2022]

Citations

Home-based supportive care in advanced cancer: systematic ...This study systematically reviewed the literature on the effect of home-based supportive care (HbSC) programmes on the quality of life (QoL) of patients with ...
Outcomes of patients with cancer cared for in a multisite ...Prior research has shown that patients cared for in home hospital have improved physical activity, and lower mortality and readmission rates.
experiences from advanced cancer patients in their last time at ...The aim of this study was to gain insights from experiences of advanced seriously ill cancer patients at home while receiving palliative treatment and being ...
The future of cancer care at home: Findings from an American ...We describe the findings from the first effort of the ACS in convening national leaders across multiple stakeholders, including the provider, payer, government ...
Home Hospitalization in Palliative Care for Advanced ...HHOSP reduced hospital readmissions, with 42.2%–91% of patients avoiding further hospitalizations. Caregivers reported feeling safe and ...
Safety and outcomes of a cancer patient urgent care clinic.UCC users had significantly (p<0.001) more advanced-stage cancer than non-UCC users (37.3% vs 18.9%), but there were no significant differences in mean age, ...
At-Home Cancer Directed Therapy versus in Clinic for the ...This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread.
National Cancer Institute Cancer Treatment Tolerability ...As cancer treatments evolve, there is a growing need to assess, analyze, and integrate measurements of cancer treatment tolerability.
Clinical Outcomes of Patients with Advanced Cancer and ...This article reports on treatment of advanced cancer with anti‐PD1 antibodies, focusing on patients with pre‐existing autoimmune disorders.
At-Home vs Clinic-Based Therapy for Advanced CancerResearch shows that at-home therapy for advanced cancer is generally safe. Studies found no major safety issues, and patients reported high satisfaction and ...
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