At-Home vs Clinic-Based Therapy for Advanced Cancer

Recruiting at 1 trial location

Overseen By Roxana S. Dronca, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Chemotherapy, Supportive care

Must not be taking: Investigational agents

Disqualifiers: Severe infection, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. In fact, it allows for certain standard of care oral drugs and anti-hormonal agents to be taken alongside the trial treatments.

What data supports the effectiveness of the treatment Clinical Encounter, Home Health Encounter for advanced cancer?

Research shows that home-based care for advanced cancer patients can effectively manage pain and improve quality of life. Studies found that home treatment led to decreased need for strong painkillers, reduced hospital stays, and was well-accepted by patients and families, making it a viable alternative to hospital care. ^{1 2 3 4 5}

Is at-home therapy for advanced cancer safe for patients?

Research shows that at-home therapy for advanced cancer is generally safe. Studies found no major safety issues, and patients reported high satisfaction and improved quality of life with home-based treatment. ^{2 4 6 7 8}

How is the At-Home vs Clinic-Based Therapy for Advanced Cancer treatment different from other treatments for this condition?

This treatment is unique because it allows advanced cancer patients to receive comprehensive care at home, including physical exams, pain management, chemotherapy, and emotional support, provided by a multidisciplinary team. This approach can reduce the need for hospital visits, decrease pain medication use, and improve quality of life, making it a flexible and patient-centered alternative to traditional hospital-based care. ^{2 5 9 10 11}

Research Team

Roxana S. Dronca, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with advanced cancer who live within 35 miles of the clinic, can handle their current chemo well, and plan to continue it for at least 24 weeks. They need Wi-Fi at home and must be able to fill out questionnaires. People needing constant help or on other treatments (except hormone therapy), with severe illnesses, recent serious infections, or unstable heart conditions cannot join.

Inclusion Criteria

I have been confirmed to tolerate standard chemotherapy well without any drug-related reactions.

Signed informed consent form by patient

Residence has Wi-Fi to enable a reliable connection with the remote Command Center

Exclusion Criteria

I am not on any clinical trial drugs or standard treatments not approved for this study, except hormone therapy for breast or prostate cancer.

I have not had a severe infection or been hospitalized for one in the last 4 weeks.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Patients receive at least 1 cycle of their standard of care chemotherapy regimen in the clinic

4 weeks

Randomized Treatment

Patients are randomized to receive chemotherapy either at home or in the clinic

24 weeks

Regular visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Clinical Encounter
• Home Health Encounter

Trial Overview The study compares receiving cancer treatment at home versus in a clinic setting. It aims to see if home-based care reduces stress and improves compliance with treatment plans. Participants will receive either clinical encounters or home health visits along with quality-of-life assessments through questionnaires.

Participant Groups

Group I: Arm B (clinic & at-home treatment) Experimental Treatment 4 Interventions

Patients continue receiving their SOC chemotherapy regimen in the clinic for approximately 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an approximate additional 16 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (at-home treatment) Experimental Treatment 3 Interventions

Patients continue receiving their SOC chemotherapy 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The hospital-at-home care program by ANT for advanced cancer patients has successfully treated 5,603 patients from 1985 to 1991, achieving a 70% rate of deaths occurring at home, which indicates a preference for home-based end-of-life care.

Pain control was effectively managed in 95% of cases, highlighting the program's efficacy in symptom management, while suggesting that eligibility for home care should consider not just medical status but also social and psychological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bologna Eubiosia Project: hospital-at-home care for advanced cancer patients. Pannuti, F., Tanneberger, S.[2017]

A study involving 218 advanced non-ambulatory cancer patients found that comprehensive home treatment led to reduced need for narcotic pain relief, fewer hospitalizations, and improved nutritional status, particularly in female patients.

Home treatment was well-accepted by patients and families, and it proved to be an effective alternative to hospital care, especially for those with better performance status, while not affecting survival rates for patients with lower performance status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative assessment of home versus hospital comprehensive treatment for advanced cancer patients. Vinciguerra, V., Degnan, TJ., Sciortino, A., et al.[2017]

Only 5.0% of patients with advanced solid tumors received outpatient specialty palliative care (OSPC) in 2016, highlighting a significant gap in access to these services.

Patients were 19 times more likely to use OSPC if their oncologist's practice was located in the same facility as the OSPC clinic, and those living closer (under 30 minutes) were also significantly more likely to access these services, indicating that clinic location and travel time are critical factors in OSPC utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

System-Level Factors Associated With Use of Outpatient Specialty Palliative Care Among Patients With Advanced Cancer. Yu, JA., Ray, KN., Park, SY., et al.[2023]

Patients with advanced colorectal cancer receiving home-based chemotherapy reported significantly higher satisfaction scores (3.58) compared to those receiving hospital-based treatment (3.23), indicating a preference for home treatment.

Home-based chemotherapy was also more cost-effective, reducing the average cost per session by 16.6% compared to hospital-based chemotherapy, making it a viable and economical option for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic and patient-reported outcomes of outpatient home-based versus inpatient hospital-based chemotherapy for patients with colorectal cancer. Joo, EH., Rha, SY., Ahn, JB., et al.[2021]

A study involving 220 advanced cancer patients demonstrated that multimodal analgesia services at home significantly improved pain relief compared to standard opioid treatments, with notable differences in pain scores (P < 0.001).

The combination of morphine with 0.4 mg of alprazolam provided better pain alleviation than morphine alone, indicating that adding midazolam can enhance the effectiveness of pain management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Feasibility of multi models targeting home pain alleviation service used on 220 cases with advanced cancer]. Huang, XH., DU, JL., Wu, CX., et al.[2014]

A multicenter study involving 104 patients with newly diagnosed acute myeloid leukemia demonstrated that home-based intensive chemotherapy is feasible and safe, with 67% of treatment days conducted at home using infusion pumps.

Patients reported high satisfaction with home treatment, which positively impacted their quality of life, allowing them to remain socially and physically active during chemotherapy without any unexpected adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia. Nørskov, KH., Fridthjof, K., Kampmann, P., et al.[2022]

A project in the Onco Pays-de-la-Loire network successfully administered home-based chemotherapy to 41 cancer patients, with no major issues reported and only 1.9% of drug preparations destroyed.

The initiative not only improved patient care and satisfaction among healthcare professionals but also resulted in reduced costs for outpatient chemotherapy, highlighting the effectiveness of coordinated nursing and pharmaceutical efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Outpatient chemotherapy and oncology network : Onco Pays-de-la-Loire experiment]. Lewden-Bernadac, B., Courant-Menanteau, M., Perrocheau, G., et al.[2022]

In a study of 175 participants, those receiving ambulatory home-based chemotherapy experienced significantly fewer severe adverse events like anemia, neutropenia, and thrombocytopenia compared to those receiving inpatient chemotherapy.

Patients in the ambulatory home-based chemotherapy group reported better social well-being, indicating that this treatment approach may enhance quality of life despite experiencing more common side effects like nausea and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of adverse events and health-related quality of life in patients with colorectal cancer receiving ambulatory home-based chemotherapy in Thailand. Sirilerttrakul, S., Wannakansophon, N., Utthiya, P., et al.[2021]

In a study of 261 patients with advanced cancer undergoing chemotherapy, those who utilized home-based nursing services early during treatment were more likely to transition to home care after their last chemotherapy session, with a transfer rate of 17.5% compared to 7.2% in the control group.

The analysis indicated that early use of home-based nursing services significantly increased the odds of transferring to home care, with an odds ratio of 3.077, suggesting that timely nursing support can positively influence post-treatment care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of a home-based nursing service during chemotherapy with the transfer to home care immediately after the last chemotherapy treatment in patients with advanced cancer. Higashibata, T., Iwata, N., Kazama, I., et al.[2022]

About 20% of outpatients with advanced cancer reported experiencing moderate to severe pain, highlighting a significant need for improved pain management in palliative care.

While many patients felt respected and had good relationships with medical staff, less than 60% felt free from physical and emotional distress, indicating that there are critical areas for improvement in the quality of palliative care provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain intensity, quality of life, quality of palliative care, and satisfaction in outpatients with metastatic or recurrent cancer: a Japanese, nationwide, region-based, multicenter survey. Yamagishi, A., Morita, T., Miyashita, M., et al.[2022]

In a study involving 97 patients with various advanced cancers, outpatient home anti-cancer chemotherapy showed effective results with no severe side effects, allowing patients to maintain a good quality of life during treatment.

The success of this outpatient approach highlights the importance of establishing dedicated therapy rooms and training expert nurses to ensure safe and effective administration of chemotherapy at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Our outpatient cases for home anti-cancer chemotherapy]. Midorikawa, Y., Suzuki, K., Kasuga, T., et al.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Bologna Eubiosia Project: hospital-at-home care for advanced cancer patients. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

A comparative assessment of home versus hospital comprehensive treatment for advanced cancer patients. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

System-Level Factors Associated With Use of Outpatient Specialty Palliative Care Among Patients With Advanced Cancer. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Economic and patient-reported outcomes of outpatient home-based versus inpatient hospital-based chemotherapy for patients with colorectal cancer. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Feasibility of multi models targeting home pain alleviation service used on 220 cases with advanced cancer]. [2014]

6. England pubmed.ncbi.nlm.nih.gov

A national Danish proof of concept on feasibility and safety of home -based intensive chemotherapy in patients with acute myeloid leukemia. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Outpatient chemotherapy and oncology network : Onco Pays-de-la-Loire experiment]. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of adverse events and health-related quality of life in patients with colorectal cancer receiving ambulatory home-based chemotherapy in Thailand. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Association of a home-based nursing service during chemotherapy with the transfer to home care immediately after the last chemotherapy treatment in patients with advanced cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Pain intensity, quality of life, quality of palliative care, and satisfaction in outpatients with metastatic or recurrent cancer: a Japanese, nationwide, region-based, multicenter survey. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Our outpatient cases for home anti-cancer chemotherapy]. [2006]