Home-Based Supportive Care for Cancer

Overseen By Ryan Nipp, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Uncontrolled psychiatric illness, impaired cognition

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is evaluating a program that entails remote monitoring and home-based care for people with cancer who are receiving chemotherapy, radiotherapy, or chemoradiotherapy.

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 doctor.

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

Research shows that home-based cancer care can improve patient quality of life and autonomy, reduce the need for pain medication, and decrease hospital stays. A study found that comprehensive home treatment by a specialized team is an effective alternative to hospital care for terminal cancer patients, with excellent acceptance by patients and families. ^{1 2 3 4 5}

Is home-based supportive care for cancer safe?

Research shows that home-based chemotherapy, a form of supportive care, is generally safe for cancer patients, with no unexpected events reported. Patients often feel satisfied and experience improved quality of life, suggesting that this approach is safe for use at home. ^{6 7 8 9 10}

How is the Home-Based Supportive Care for Cancer treatment different from other cancer treatments?

This treatment is unique because it allows cancer patients to receive care at home, which can improve their quality of life by keeping them in a familiar environment and reducing hospital visits. It involves a team of healthcare professionals providing coordinated support, including pain management, psychological help, and assistance with daily activities, which is not typically offered in standard cancer treatments. ^{5 11 12 13 14}

Research Team

Ryan Nipp, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with certain cancers (pancreatic, gastroesophageal, rectal, head and neck) who are starting treatment. They must live within 50 miles of Massachusetts General Hospital, speak English fluently, and plan to receive care at MGH.

Inclusion Criteria

I am 18 years old or older.

I am undergoing treatment aimed at curing my cancer in the pancreas, stomach, esophagus, rectum, or head and neck.

Verbally fluent in English

Exclusion Criteria

Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either usual care or supportive oncology care at home, including remote monitoring and questionnaires

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Supportive Oncology Care at Home
• Usual Care

Trial Overview The study is testing a home-based supportive oncology care program against usual care for cancer patients undergoing treatments like chemotherapy or radiotherapy. It involves remote monitoring and home care services.

Participant Groups

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

The research study procedures include: * Remote monitoring of symptoms, vitals, and body weight * Questionnaires asking about demographic information (e.g. gender, ethnicity, income) and experience with cancer (e.g. quality of life, symptoms) * Data collection from medical record

Group II: Usual Care Active Control 1 Intervention

Participants assigned to the standard care arm will receive standard oncology care and attend regular clinic visits. Participants on the standard care arm will complete questionnaires from baseline up to 6 months following enrollment.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Medically Home

Collaborator

Trials

2

Recruited

370+

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]

Supportive cancer care encompasses comprehensive assistance for patients, including pain management, psychological support, and access to therapies, which is crucial for improving quality of life during treatment.

In France, the establishment of supportive care centers in hospitals aims to enhance coordination among multidisciplinary teams, particularly benefiting patients with bone metastasis through tailored interventions like bisphosphonates and physiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Supportive care for urological metastatic patients]. Lebret, T., Di Palma, M., Ripoll, J., et al.[2008]

References

1. 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]

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

The quality of supportive cancer care in the veterans affairs health system and targets for improvement. [2017]

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

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

4. Japan pubmed.ncbi.nlm.nih.gov

[A comparison of the characteristics on cancer and non-cancer in-patients receiving a registration system based home support]. [2011]

5. France pubmed.ncbi.nlm.nih.gov

[Needs assessment for the establishment of an Oral Therapy Unit]. [2023]

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. Denmark pubmed.ncbi.nlm.nih.gov

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

8. Japan pubmed.ncbi.nlm.nih.gov

[Results of survey conducted on perioperative chemotherapy and supportive care in primary breast cancer (JBCRG01)]. [2007]

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

Assessment of adverse events via a telephone consultation service for cancer patients receiving ambulatory chemotherapy. [2018]

10. 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]

11. France pubmed.ncbi.nlm.nih.gov

[Supportive care in oncology: definition, organization, limits]. [2019]

12. France pubmed.ncbi.nlm.nih.gov

[Supportive care for urological metastatic patients]. [2008]

13. England pubmed.ncbi.nlm.nih.gov

Experiences in home care of cancer patients. A new approach in cancer nursing. [2019]

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

[Supportive therapy in oncology]. [2022]