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Behavioural Intervention
At-Home vs Clinic-Based Therapy for Advanced Cancer
Phase 2
Recruiting
Led By Roxana S. Dronca, M.D.
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean patient-reported rating of Cancer Connected Access and Remote Expertise
Secondary outcome measures
Emergency room visits and hospitalizations
Incidence of adverse events
Overall survival
+6 moreTrial 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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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,288 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,511 Patients Enrolled for Multiple Myeloma
Roxana S. Dronca, M.D.Principal InvestigatorMayo Clinic
2 Previous Clinical Trials
62 Total Patients Enrolled
Roxana S Dronca, M.D.Principal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been confirmed to tolerate standard chemotherapy well without any drug-related reactions.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.I am 18 years old or older.I am receiving chemotherapy for my confirmed cancer.I do not have any severe illnesses or conditions that would stop me from following the study's requirements.I can take care of myself and am up and about more than half of my waking hours.I am not currently admitted to a hospital.I need help all day with my daily activities.I've tolerated my standard chemotherapy well, without any drug-related reactions.I expect to need major surgery while on the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (clinic & at-home treatment)
- Group 2: Arm A (at-home treatment)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the potential risks of using Arm A (at-home treatment) for patients?
"Our team at Power gave Arm A (at-home treatment) a safety score of 2 on the 1 to 3 scale, as there is sufficient evidence suggesting it is safe but not enough data demonstrating efficacy."
Answered by AI
Are there any available spots in this clinical trial?
"Clinicaltrials.gov shows that this medical trial has stopped recruiting, having been initially posted on September 1st 2023 and last updated on July 24th of the same year. However, there are 7558 other clinical trials actively looking for patients at present."
Answered by AI
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