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The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas

ConditionsAmyloidosisBasal Cell CarcinomaBiliary Tract CarcinomaBladder CarcinomaBreast CarcinomaCervical CarcinomaColorectal CarcinomaEndometrial CarcinomaFallopian Tube CarcinomaGastroesophageal Junction CarcinomaGlioblastomaHead and Neck CarcinomaHematopoietic and Lymphatic System NeoplasmHepatocellular CarcinomaHodgkin LymphomaLung CarcinomaMalignant Solid NeoplasmMantle Cell LymphomaMelanomaMerkel Cell CarcinomaMultiple MyelomaMyelodysplastic SyndromeOvarian CarcinomaPancreatic CarcinomaPrimary Peritoneal CarcinomaProstate CarcinomaRenal Cell CarcinomaSquamous Cell CarcinomaUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent

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) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO], American Society of Hematology [ASH], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines

A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician

Disqualifiers

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

Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.

Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial

Individuals who require continuous (24/7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study

Trial design

Design model

Single group

Treatments tested in this trial

  • Cancer Therapeutic Procedure

    Drug

    Receive in-home standard of care cancer-treatment

  • Cancer Therapeutic Procedure

    Drug

    Receive in-clinic standard of care cancer-treatment

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Health services research (CCBW in-home cancer treatment)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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 outcomes

1

Change in Patient-reported Function - EORTC-QLQ-F17

Assessed using the 15 function-related questions from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-F17. The F17 is an abbreviated version of the EORTC-QLQ-C30 questionnaire (30 questions), which is used to assess the quality of life of cancer patients. The F17 is composed solely of items related to function. It also includes two questions related to health status and quality of life (QOL). Fifteen function questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4= very much), and two health/QOL questions are answered on a scale of 1-7 where 1= very poor and 7=excellent. Higher summary scores indicate greater overall function and better health related quality of life.

Time frame
Baseline, week 12, and week 24
2

Change in Patient-reported Global Health/Quality of Life - EORTC-QLQ-F17

Assessed by two questions from the EORTC-QLQ-F17 related to Global Health Status/Quality of Life (QL) scale. These questions are answered on a scale of 1-7 where 1= very poor and 7=excellent. Higher summary scores indicate better health related quality of life.

Time frame
Baseline, week 12, and week 24
3

Patient-reported Symptoms - PRO-CTCAE

As measured by the Patient Reported Outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE scores will be summarized using composite scores. The PRO-CTCAE was developed to assess patient self-reported symptoms in cancer clinical trials. The PRO-CTCAE consists of 27 questions related to symptoms and side effects experienced over the past 7 days. Each question is answered on a 5-point scale (e.g., none/mild/moderate/severe/very severe or never/rarely/occasionally/frequently/almost constantly). The final question is an opportunity to list any other symptoms not included in the assessment. Higher scores indicate experience of worse or more frequent/severe symptoms and side effects.

Time frame
At baseline, week 12, and week 24
4

Patient-reported Symptoms - FACT GP5

As measured by the Functional Assessment of Cancer Therapy General 5 (FACT GP 5), a single question evaluating how much participants were bothered by treatment side effects over the past 7 days. The question is answered on a scale of 0-4, where 0=not at all, 1=a little bit, 2-somewhat, 3-quite a bit, and 4=very much.

Time frame
Baseline, week 12, and week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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