Supportive Oncology Care At Home RCT
Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started Sep 2020
Longer than P75 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedStudy Start
First participant enrolled
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 21, 2026
April 1, 2026
6.3 years
September 3, 2020
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants requiring a hospital admission or emergency department visit
Compare the difference between study arms using Fisher's exact tests, and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender).
baseline to 6 months
Secondary Outcomes (10)
Proportion of days participants spend outside of the hospital during the study period
baseline to 6 months
Proportion of patients needing an urgent visit to clinic
baseline to 6 months
Rate of treatment delays
baseline to 6 months
Comparison of dose intensity
baseline to 6 months
Change in symptom burden (ESAS)
baseline up to 6 months
- +5 more secondary outcomes
Study Arms (2)
Usual Care
ACTIVE COMPARATORParticipants 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.
Supportive Oncology Care at Home
EXPERIMENTALThe 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
Interventions
Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.
Standard care arm will receive standard oncology care and attend regular clinic visits.
Eligibility Criteria
You may qualify if:
- To be eligible, patients must be: age 18 or older
- Receiving definitive treatment (i.e. neoadjuvant chemotherapy and/or chemoradiation with curative intent) for pancreatic, gastroesophageal, rectal, head and neck cancer, or lymphoma
- Within two weeks of starting treatment
- Planning to receive care at Massachusetts General Hospital (MGH)
- Verbally fluent in English
- Residing within 50 miles of Massachusetts General Hospital
You may not qualify if:
- Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Medically Homecollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Nipp RD, Shulman E, Smith M, Brown PMC, Johnson PC, Gaufberg E, Vyas C, Qian CL, Neckermann I, Hornstein SB, Reynolds MJ, Greer J, Temel JS, El-Jawahri A. Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer. BMC Cancer. 2022 Apr 9;22(1):383. doi: 10.1186/s12885-022-09461-z.
PMID: 35397575DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Nipp, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 3, 2020
First Posted
September 10, 2020
Study Start
September 16, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.