RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-23

Study Completion:2025-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05969860

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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, or biliary cancer * Gemcitabine for pancreatic, biliary 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, or cervical cancer * Avastin for glioblastoma, colorectal, and cervical cancer * Avastin, avastin + temozolomide, avastin + lomustine, or avastin + afinitor for glioblastoma * Cisplatin/fluorouracil (5-FU) for anal cancer * 5-FU/leucovorin +/- Avastin for colorectal, pancreas or gastric cancer * FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal, pancreas cancer * Paclitaxel for breast cancer, bladder cancer * Trastuzumab with or without pertuzumab maintenance (subcutaneously \[SQ\] or intravenously \[IV\]) for HER2 positive breast cancer in the adjuvant or metastatic setting * Trastuzumab + paclitaxel for Her-2 positive breast cancer * Leuprolide for prostate cancer and breast cancer * Degarelix for prostate cancer * Goserelin acetate for breast cancer * Fulvestrant for breast cancer * Bortezomib for multiple myeloma * Carfilzomib for multiple myeloma * Decitabine for myelodysplastic syndrome * Only patients receiving decitabine for myelodysplastic syndrome (MDS) are eligible for these supportive medications: * Darbepoetin-alfa * Epoetin * Filgrastim * Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible supportive care drugs for treatment of bone metastases: * Zoledronic acid * Denosumab * 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 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 * 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) * 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 chemotherapy treatment and no drug-related infusion reactions since pre-registration and prior to registration	* 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 * 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. Note: concomitant radiation therapy during the study period is allowed

Inclusion Criteria

Exclusion 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, or biliary cancer
* Gemcitabine for pancreatic, biliary 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, or cervical cancer
* Avastin for glioblastoma, colorectal, and cervical cancer
* Avastin, avastin + temozolomide, avastin + lomustine, or avastin + afinitor for glioblastoma
* Cisplatin/fluorouracil (5-FU) for anal cancer
* 5-FU/leucovorin +/- Avastin for colorectal, pancreas or gastric cancer
* FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal, pancreas cancer
* Paclitaxel for breast cancer, bladder cancer
* Trastuzumab with or without pertuzumab maintenance (subcutaneously \[SQ\] or intravenously \[IV\]) for HER2 positive breast cancer in the adjuvant or metastatic setting
* Trastuzumab + paclitaxel for Her-2 positive breast cancer
* Leuprolide for prostate cancer and breast cancer
* Degarelix for prostate cancer
* Goserelin acetate for breast cancer
* Fulvestrant for breast cancer
* Bortezomib for multiple myeloma
* Carfilzomib for multiple myeloma
* Decitabine for myelodysplastic syndrome
* Only patients receiving decitabine for myelodysplastic syndrome (MDS) are eligible for these supportive medications:
* Darbepoetin-alfa
* Epoetin
* Filgrastim
* Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the following eligible supportive care drugs for treatment of bone metastases:
* Zoledronic acid
* Denosumab
* 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 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
* 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)
* 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 chemotherapy treatment and no drug-related infusion reactions since pre-registration and prior to registration

* 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
* 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. Note: concomitant radiation therapy during the study period is allowed

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Roxana S. Dronca, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Roxana S. Dronca, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-23

Study Completion Date2025-01-01

Study Record Updates