Study Summary
This trial is testing a program of remotely monitoring patients with cancer who are receiving chemo, radiotherapy, or chemoradiotherapy, and providing them with home-based care.
Eligible Conditions
- Gastroesophageal Cancer
- Pancreatic Cancer
- Colorectal Cancer
- Head and Neck Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: baseline to 6 months
baseline to 6 months
Change in Activities of Daily Living (ADLs)
Change in Instrumental Activities of Daily Living (IADLs)
Change in care satisfaction (FAMCARE)
Change in psychological distress (HADS)
Change in quality of life (FACT-G)
Comparison of dose intensity
Proportion of days participants spend outside of the hospital during the study period
Proportion of participants requiring a hospital admission or emergency department visit
Proportion of patients needing an urgent visit to clinic
Rate of treatment delays
Month 6
Change in symptom burden (ESAS)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Usual Care
1 of 2
Supportive Oncology Care at Home
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: Supportive Oncology Care at Home · No Placebo Group · N/A
Supportive Oncology Care at Home
Other
Experimental Group · 1 Intervention: Supportive Oncology Care at Home · Intervention Types: OtherUsual Care
Other
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months
Who is running the clinical trial?
Medically HomeUNKNOWN
1 Previous Clinical Trials
105 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,700 Previous Clinical Trials
30,852,832 Total Patients Enrolled
Ryan Nipp, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
4 Previous Clinical Trials
434 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If you are planning to receive care at Massachusetts General Hospital (MGH), there are a few things you need to know
and Spanish
I am fluent in English and Spanish.
You have received definitive treatment for pancreatic, gastroesophageal, rectal, or head and neck cancer.
References
- Nipp, Ryan D., Eliza Shulman, Melissa Smith, Patricia M. C. Brown, P. Connor Johnson, Eva Gaufberg, Charu Vyas, et al.. 2022. “Supportive Oncology Care at Home Interventions: Protocols for Clinical Trials to Shift the Paradigm of Care for Patients with Cancer”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-022-09461-z.
- Ryan Nipp 2020. "Supportive Oncology Care At Home RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04544046.
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Conditions
Cancer Related
Treatments