At-home cancer treatment versus clinic-based treatment for advanced cancer patients

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

This study tests whether giving cancer treatment at home is better for comfort and satisfaction compared to getting it at a clinic for people with advanced cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Drugs / interventions: nivolumab, pembrolizumab, bevacizumab, trastuzumab, Atezolizumab, Avelumab, Cemiplimab, durvalumab, Daratumumab, tremelimumab, relatlimab, Pertuzumab, Rituximab, Denosumab, cobimetinib, axitinib, lenvatinib, cabozantinib, trametinib, tucatinib, immunotherapy, cyclophosphamide
• Locations: 2 sites (Jacksonville, Florida and 1 other locations)
• Trial ID: NCT05969860 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of administering cancer-directed therapy at home compared to traditional in-clinic treatment for patients with advanced cancer. The study aims to assess patient-reported experiences and preferences regarding the location of treatment administration. Participants will be randomized to receive either home-based or clinic-based therapy, and their comfort, quality of life, and overall satisfaction will be measured over a 24-week period. The trial seeks to explore innovative care delivery models that could alleviate the burden of cancer treatment on patients and their families.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed advanced malignancies currently receiving specific chemotherapy regimens.

Not a fit: Patients who are not currently undergoing chemotherapy or those with non-advanced cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the quality of life for patients by providing more convenient and comfortable treatment options.

How similar studies have performed: Other studies have shown promising results with home-based cancer treatment approaches, indicating potential for success in this novel application.

Eligibility criteria

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

Where this trial is running

Jacksonville, Florida and 1 other locations

• Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
• Altru Cancer Center — Grand Forks, North Dakota, United States (Recruiting)

Study contacts

• Principal investigator: Roxana S. Dronca, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office

Conditions Advanced Anal Carcinoma; Advanced Biliary Tract Carcinoma; Advanced Bladder Carcinoma; Advanced Breast Carcinoma; Advanced Carcinoid Tumor; Advanced Cervical Carcinoma; Advanced Colorectal Carcinoma; Advanced Gastric Carcinoma