At-Home vs Clinic-Based Therapy for Advanced Cancer

Phase 2

Recruiting

Led By Roxana S. Dronca, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effects of giving cancer treatment at-home, instead of in a clinic, to reduce psychological/financial distress & increase treatment compliance.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since patients continue their current chemotherapy regimens, side effects are not introduced by new drugs but may include typical chemo-related issues like nausea, fatigue, hair loss, increased infection risk, and potential infusion reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean patient-reported rating of Cancer Connected Access and Remote Expertise

Secondary study objectives

Emergency room visits and hospitalizations

Incidence of adverse events

Overall survival

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (clinic & at-home treatment)Experimental Treatment4 Interventions

Patients continue receiving their SOC chemotherapy regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (at-home treatment)Experimental Treatment3 Interventions

Patients continue receiving their SOC chemotherapy regimen at home for approximately 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the HHNP, overseen by Mayo Clinic's home health program CCBW Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.

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