Clinical trial · Interventional

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

NCT05969860CI-TRIAL-00108799recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (44)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Anal Carcinoma	Anal Carcinoma	CURATED_BROADER	0.78
Advanced Appendix Carcinoma	Appendix Carcinoma	CURATED_BROADER	0.78
Advanced Basal Cell Carcinoma	Basal Cell Carcinoma	CURATED_BROADER	0.78
Advanced Biliary Tract Carcinoma	Biliary Tract Carcinoma	CURATED_BROADER	0.78
Advanced Bladder Carcinoma	Bladder Carcinoma	CURATED_BROADER	0.78
Advanced Breast Carcinoma	Breast Carcinoma	CURATED_BROADER	0.78
Advanced Carcinoid Tumor	Neuroendocrine Tumor	CURATED_BROADER	0.78

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Clinical Encounter	Procedure	—	UNRESOLVED
Home Health Encounter	Other	—	UNRESOLVED
Quality-of-Life Assessment	Other	—	UNRESOLVED
Questionnaire Administration	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm A (at-home treatment)
description
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.
interventionNames
1. Other: Home Health Encounter
2. Other: Quality-of-Life Assessment
3. Other: Questionnaire Administration
type
EXPERIMENTAL
label
Arm B (clinic & at-home treatment)
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.
* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.

  * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:
  * Eligible disease cancer types:

    * Anal cancer
    * Appendiceal carcinoma
    * Basal cell carcinoma
    * Bladder cancer
    * Biliary cancer
    * Breast cancer
    * Central Nervous System malignancy including glioblastoma
    * Cervical cancer
    * Cholangiocarcinoma
    * Colorectal carcinoma
    * Endometrial cancer
    * Fallopian tube cancer
    * Gastroesophageal cancer \[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\]
    * Germ cell carcinoma
    * Head and Neck cancer
    * Hepatocellular Carcinoma
    * Liver
    * Lung
    * Lymphoma
    * Melanoma
    * Merkel Cell
    * Multiple Myeloma
    * Myelodysplastic syndrome
    * Myeloid Disorders
    * Neuroendocrine carcinoma
    * Ovarian cancer
    * Pancreatic adenocarcinoma
    * Penile carcinoma
    * Peritoneal carcinoma
    * Prostate cancer
    * Renal cell cancer
    * Sarcoma
    * Squamous cell Carcinoma of the Skin
    * Testicular cancer
    * Urethral carcinoma
    * Vaginal carcinoma
    * Vulvar carcinoma
  * Eligible Regimens

    * Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab
    * 5FU +/- leucovorin +/- bevacizumab +/- nivolumab
    * Atezolizumab +/- bevacizumab
    * Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib
    * Avelumab
    * Avelumab + axitinib
    * Bevacizumab
    * Bevacizumab + capecitabine
    * Bevacizumab + irinotecan (+/- capecitabine)
    * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib
    * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus
    * Bevacizumab + trifluridine/tipiracil
    * Bortezomib
    * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor
    * Bortezomib + venetoclax
    * Carfilzomib
    * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor
    * Carfilzomib + venetoclax
    * Cemiplimab
    * Cisplatin
    * Cisplatin/5-FU
    * Cisplatin/etoposide
    * Cisplatin + durvalumab
    * Cisplatin + gemcitabine
    * Cisplatin + gemcitabine + durvalumab
    * Daratumumab (+ oral \[PO\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
    * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
    * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)
    * Degarelix
    * Durvalumab
    * Durvalumab + tremelimumab
    * Eribulin
    * FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan)
    * Fam-trastuzumab deruxtecan
    * Fulvestrant
    * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib
    * Gemcitabine
    * Gemcitabine + durvalumab
    * Gemcitabine + paclitaxel protein-bound
    * Goserelin acetate
    * Irinotecan
    * Irinotecan + capecitabine
    * Lanreotide
    * Leuprolide
    * Nivolumab
    * Nivolumab + cabozantinib
    * Nivolumab-relatlimab
    * Octreotide
    * Paclitaxel
    * Pembrolizumab
    * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)
    * Pemetrexed
    * Pertuzumab
    * Pemetrexed + pembrolizumab
    * Rituximab
    * Trastuzumab + paclitaxel
    * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)
    * Decitabine
    * These regimens can be used only if patients are receiving one of the regimens above:

      * Darbepoetin-alfa
      * Epoetin
      * Filgrastim
* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:

  * Zoledronic acid
  * Denosumab
* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent
* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.
* Residing within the area serviced by supplier and paramedic network
* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution
* 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 judgement
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
* Ability to complete questionnaire(s) by themselves or with assistance
* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration

Exclusion Criteria:

* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \[IM\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs
* 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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Aug 23, 2023
Primary completion: Jan 1, 2027
Completion: Jan 1, 2027
First posted: Aug 1, 2023
Last update posted: Apr 20, 2026
Enrollment: 220 (estimated)
Lead sponsor: Mayo Clinic OTHER

Data updated 22 days agoSource updated Apr 20, 2026source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	2

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.