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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible treatment regimens. 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

∙ 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 + vermurafenib, atezolizumab +/- bevacizumab + cobimetinib + vermurafenib

∙ 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

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
North Dakota
Altru Cancer Center
RECRUITING
Grand Forks
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-08-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200
Treatments
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.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov