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

Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic

INTRODUCTION

  • Org Study ID: MC220709
  • Secondary ID: N/A
  • NCT ID: NCT05969860
  • Sponsor: Mayo Clinic

BRIEF SUMMARY

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.

DETAILED DESCRIPTION

PRIMARY OBJECTIVE:

I. To compare mean patient-reported rating of Cancer Connected Access and Remote Expertise (CARE) using a modified question from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey after 8 weeks between patients randomized to receive care at home and care in the clinic.

SECONDARY OBJECTIVES:

I. To evaluate patient preference for location of cancer treatment administration, at the infusion center or in the home.

II. To evaluate level of comfort with receiving infusions at home based on the following measures after 24 weeks of treatment (or at end of study):

IIa. The proportion of patients who indicate a preference for home infusion or no preference versus outpatient infusion unit administration of cancer treatment as assessed via the Patient Preference Questionnaire; IIb. The proportion of patients who indicate comfort (quite a bit or very much) with receiving infusions at home as assessed by the Patient Preference Questionnaire.

III. To describe other patient experience questions within the Patient Preference Questionnaire after 24 weeks of treatment (or at end of study).

IV. To describe whether patients felt that infusions at home was worthwhile, would do it again, and recommend it to others after 24 weeks of treatment (or at end of study) using the Was It Worth It questionnaire.

V. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported function and global health/quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Function 17-Item (EORTC QLQ-F17) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VI. To test whether home-based virtual delivery of cancer directed therapy is superior to standard administration (in clinic) in patient-reported symptoms as measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) after 8 weeks of home versus outpatient infusion unit administration of cancer treatment.

VII. To assess the safety of cancer directed therapy when administered at home by a home health provider with remote patient monitoring and Command Center support, based on the incidence, nature, and severity of the following:

VIIa. Grade 3+ adverse event (AE) clinically graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

VIII. To test whether home-based virtual delivery of cancer directed therapy is superior to standard in clinic administration in the proportion of patients with an emergency room visit or hospitalization at the end of 6 months of study treatment.

IX. Overall survival.

EXPLORATORY OBJECTIVES:

I. To assess the cost of care in first 6 months (data collected out to 1 year). II. To evaluate administration of treatment based on clinical practice data.

OUTLINE:

Patients receive the first 2 cycles of their standard of care (SOC) chemotherapy regimen in the clinic in the absence of disease progression or unacceptable toxicity. Patients are then randomized to 1 of 2 arms.

ARM A: Patients continue receiving their SOC chemotherapy regimen at home for 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 Home Health Nurse Provider (HHNP), overseen by Mayo Clinic's home health program Cancer CARE Beyond Walls (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.

ARM B: Patients continue receiving their SOC chemotherapy regimen in the clinic for 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 additional 16 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study intervention, patients are followed for 1 year.

  • Overall Status
    Recruiting
  • Start Date
    August 23, 2023
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Mean patient-reported rating of Cancer Connected Access and Remote Expertise

Primary Outcome 1 - Timeframe: At 8 weeks

CONDITION

  • Advanced Malignant Solid Neoplasm
  • Anal Carcinoma
  • Biliary Tract Carcinoma
  • Bladder Carcinoma
  • Breast Carcinoma
  • Carcinoid Tumor
  • Cervical Carcinoma
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Glioblastoma
  • Head and Neck Carcinoma
  • HER2-Positive Breast Carcinoma
  • Lung Carcinoma
  • Lung Small Cell Carcinoma
  • Malignant Germ Cell Tumor
  • Neuroendocrine Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Prostate Small Cell Neuroendocrine Carcinoma

ELIGIBILITY

Inclusion Criteria:
* Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible chemotherapy treatment regimens:
* Cisplatin/gemcitabine for bladder, lung, biliary, or breast cancer

- * Gemcitabine for pancreatic or ovarian cancer

- * Cisplatin/etoposide for small cell lung cancer, germ cell carcinoma, small cell prostate cancer, and neuroendocrine/carcinoid cancer

- * Cisplatin for lung, bladder, head and neck, cervical, and breast cancer, and glioblastoma

- * Avastin for glioblastoma, breast, colorectal, and cervical cancer

- * Cisplatin/fluorouracil (5-FU) +/- Avastin for anal cancer

- * 5-FU/leucovorin +/- Avastin for colorectal or gastric cancer

- * FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal cancer

- * Paclitaxel for breast or bladder cancer

- * Trastuzumab maintenance for Her-2 positive breast cancer

- * Trastuzumab + paclitaxel for Her-2 positive breast cancer

- * Leuprolide for prostate and breast cancer

- * Goserelin acetate for breast cancer

- * Patient has had adequate tolerability of their clinical standard of care chemotherapy treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent.

- * Patients have no documented reason to suspect they won't continue the treatment regimen they are currently prescribed

- * Residing within 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network

- * Residence has wireless fidelity (Wi-Fi) to enable a reliable connection with the remote Command Center

- * Age >= 18 years at time of registration

- * Signed informed consent form by patient

- * Willing and able to comply with the study protocol in the investigator's judgment

- * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

- * Ability to complete questionnaire(s)
Exclusion Criteria:
* Receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimens (except hormone therapy for breast or prostate cancer)

- * Requiring 24/7 assistance with activities of daily living (ADLs)

- * Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)

- * 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

- * Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection

- * Symptomatic congestive heart failure

- * Unstable angina pectoris

- * Cardiac arrhythmia

- * Myocardial infarction =< 6 months - * Wound healing disorder - * Or psychiatric illness/social situations that would limit compliance with study requirements - * Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed coronavirus disease 2019 [COVID-19] infection) - * Anticipation of the need for major surgery during the course of study treatment

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Roxana S Dronca, M.D.

Role: Principal Investigator

Affiliation: Mayo Clinic

Overall Contact

Name: Roxana S Dronca, M.D.

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Status: Recruiting Contact: Contact
Clinical Trials Referral Office
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator
Roxana S. Dronca, M.D.