Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas
Summary
This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.
Arms & interventions
- DrugCancer Therapeutic Procedure
Receive in-home standard of care cancer-treatment
- DrugCancer Therapeutic Procedure
Receive in-clinic standard of care cancer-treatment
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Patient preferences regarding location of cancer treatment delivery
As assessed by a single item asking patients to rate their preferred location for cancer treatment delivery on a 1 to 7 scale: 1 = strongly prefer in clinic, 2 = moderately prefer in clinic, 3 = slightly prefer in clinic, 4 = no preference, 5 = slightly prefer at home, 6 = moderately prefer at home, 7 = strongly prefer at home. Patients who receive any care in the mobile unit will be instructed to consider "at home" to mean receipt of care inside their home or near their home in the mobile unit.
Time frame: At 12 weeks
Adverse Events Related to Location of Treatment
Safety of at-home administration of cancer treatment will be assessed by incidence of grade 3+ adverse events at least possibly related to the location of cancer treatment delivery that occur up to 30 days after the administration of the last dose of study drug/agent or therapy. The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 9 months
Incidence of avoidable acute care visits, emergency room visits, and hospitalizations
Safety of at-home administration of cancer treatment will be assessed by the frequency and proportion of patients who experience an avoidable (in the opinion of the treating physician) acute care visit, emergency room visit, or hospitalization while receiving at-home cancer treatment.
Time frame: Up to 24 weeks
Secondary
Change in Patient-reported Function - EORTC-QLQ-F17
Time frame: Baseline, week 12, and week 24
Change in Patient-reported Global Health/Quality of Life - EORTC-QLQ-F17
Time frame: Baseline, week 12, and week 24
Patient-reported Symptoms - PRO-CTCAE
Time frame: At baseline, week 12, and week 24
Patient-reported Symptoms - FACT GP5
Time frame: Baseline, week 12, and week 24
Patient-reported Satisfaction - Patient Satisfaction & Feedback
Time frame: 12 weeks, 24 weeks
Patient-reported Satisfaction - Was It Worth It
Time frame: 12 weeks, 24 weeks
Eligibility criteria
Study locations (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980