At-Home Supportive Cancer Care for Advanced Cancer

Overseen By Ryan D Nipp, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: ICU admission, High oxygen, Angina, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

110 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is evaluating if a program that involves remote monitoring and home-based care may improve the post-discharge care of recently hospitalized patients with advanced cancer. The Supportive Oncology Care at Home intervention consists of three key components: 1. Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight); 2. A Medically Home care model for symptom assessment, evaluation, and management (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified); 3. Structured communication with the oncology team to ensure continuity of care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Supportive Oncology Care at Home for advanced cancer?

Research shows that home treatment for advanced cancer patients can reduce the need for strong pain medications, shorten hospital stays, and improve certain health measures. Patients and families also accept home care well, making it a good alternative to hospital care. ^{1 2 3 4 5}

Is at-home supportive cancer care safe for humans?

Research shows that home-based chemotherapy is generally safe for patients with various types of cancer, including colorectal cancer and acute myeloid leukemia. Studies found no unexpected adverse events, and patients reported high satisfaction and improved quality of life. Home-based treatment allows patients to be more involved in their care and remain socially and physically active. ^{6 7 8 9 10}

How is the treatment 'Supportive Oncology Care at Home' different from other treatments for advanced cancer?

Supportive Oncology Care at Home is unique because it provides comprehensive cancer care directly in the patient's home, involving a multidisciplinary team that offers services like pain control, chemotherapy, and psychosocial support, which can reduce the need for hospital visits and improve quality of life. ^{1 10 11 12 13}

Research Team

Ryan D Nipp, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for English-speaking adults over 18 with advanced cancer, recently hospitalized at MGH without ICU care. They must live within 50 miles of MGH and be discharged home, not to hospice or other locations. Caregivers and clinicians involved in their care are also eligible if they meet similar criteria.

Inclusion Criteria

Caregiver Eligibility

I am diagnosed with advanced cancer and am receiving treatment to ease symptoms.

Patient Eligibility

Exclusion Criteria

I am currently in the intensive care unit.

Caregiver Exclusion

I am scheduled for a surgery or medical procedure that requires a hospital stay.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the Supportive Oncology Care at Home program, which includes remote monitoring and home-based care, for 14 days following hospital discharge

2 weeks

Daily remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after the treatment phase, including assessments of quality of life and symptom burden

4 weeks

Treatment Details

Interventions

• Supportive Oncology Care at Home

Trial Overview The study tests a home-based supportive oncology care program post-discharge involving remote monitoring (symptoms, vitals), Medically Home model for symptom management, and structured communication with the oncology team.

Participant Groups

Group I: Supportive Oncology Care at Home Experimental Treatment 1 Intervention

Participants will receive the Supportive Oncology Care at Home program for 14 days following their discharge from the hospital. The Supportive Oncology Care at Home intervention consists of three key components: * Daily monitoring of patient-reported symptoms, vital signs, and body weight. * Medically Home care based on algorithmic changes in patients' daily symptoms, vital signs, and body weight. * Structured communication with the oncology team regarding care delivered to ensure continuity of care.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Medically Home Group, Inc.

Collaborator

Trials

1

Recruited

110+

Findings from Research

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]

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]

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]

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]

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]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

[Importance of home care personally to individuals with advanced cancer and their families]. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Oral anticancer therapy project: Clinical utility of a specific home care nursing programme on behalf of Italian Association of Medical Oncology (AIOM). [2020]

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

Impact of an educational program on pain management in patients with cancer living at home. [2013]

5. Italy pubmed.ncbi.nlm.nih.gov

[Out-of-the-hospital care for terminal cancer patients. Clinical and organizational features. Our experience]. [2006]

6. 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]

7. 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]

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

Safe chemotherapy in the home environment. [2016]

9. Denmark pubmed.ncbi.nlm.nih.gov

Safety and feasibility of home-based chemotherapy. [2018]

10. Japan pubmed.ncbi.nlm.nih.gov

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

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

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

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

Impact of specialist home-based palliative care services in a tertiary oncology set up: a prospective non-randomized observational study. [2020]

13. Japan pubmed.ncbi.nlm.nih.gov

[Ten years experience of home parenteral nutrition or hydration in advanced cancer patients]. [2006]