At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT05969860
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Anal Carcinoma
  • Advanced Appendix Carcinoma
  • Advanced Basal Cell Carcinoma
  • Advanced Biliary Tract Carcinoma
  • Advanced Bladder Carcinoma
  • Advanced Breast Carcinoma
  • Advanced Carcinoid Tumor
  • Advanced Cervical Carcinoma
  • Advanced Cholangiocarcinoma
  • Advanced Colorectal Carcinoma
  • Advanced Endometrial Carcinoma
  • Advanced Esophageal Carcinoma
  • Advanced Fallopian Tube Carcinoma
  • Advanced Gastric Carcinoma
  • Advanced Gastroesophageal Junction Adenocarcinoma
  • Advanced Glioblastoma
  • Advanced HER2 Positive Breast Carcinoma
  • Advanced Head and Neck Carcinoma
  • Advanced Hepatocellular Carcinoma
  • Advanced Liver Carcinoma
  • Advanced Lung Carcinoma
  • Advanced Lung Small Cell Carcinoma
  • Advanced Lymphoma
  • Advanced Malignant Germ Cell Tumor
  • Advanced Malignant Solid Neoplasm
  • Advanced Malignant Testicular Neoplasm
  • Advanced Melanoma
  • Advanced Merkel Cell Carcinoma
  • Advanced Neuroendocrine Carcinoma
  • Advanced Ovarian Carcinoma
  • Advanced Pancreatic Carcinoma
  • Advanced Penile Carcinoma
  • Advanced Primary Malignant Central Nervous System Neoplasm
  • Advanced Prostate Carcinoma
  • Advanced Prostate Small Cell Neuroendocrine Carcinoma
  • Advanced Renal Cell Carcinoma
  • Advanced Sarcoma
  • Advanced Skin Squamous Cell Carcinoma
  • Advanced Urethral Carcinoma
  • Advanced Vaginal Carcinoma
  • Advanced Vulvar Carcinoma
  • Hematopoietic and Lymphoid System Neoplasm
  • Multiple Myeloma
  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clinical Encounter — PROCEDURE
    Receive treatment in clinic
  • Home Health Encounter — OTHER
    Receive at-home treatment
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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 from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.

Key Dates

Start date
Aug 23, 2023
Status verified
Apr 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (at-home treatment)
    Patients continue receiving their SOC treatment 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.
  • Experimental: Arm B (clinic & at-home treatment)
    Patients continue receiving their SOC treatment regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC treatment regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Mean patient-reported rating of Cancer Connected Access and Remote Expertise [ Time Frame: At 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Roxana S. Dronca, MD (PRINCIPAL_INVESTIGATOR)
Altru Cancer CenterGrand ForksNorth Dakota58201
Alexis Tatum
[email protected]
701-780-5400
Grant Seeger, MD (PRINCIPAL_INVESTIGATOR)

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