Supportive Oncology Care At Home RCT

NCT ID: NCT04544046

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Participants receiving treatment for cancer often require multiple care visits and may experience significant symptoms and side-effects related to the cancer and the cancer treatment.

This research study is evaluating if a program that involves remote monitoring and home-based care may improve the quality of life, ability to manage symptoms, and overall care of individuals during cancer treatment. Remote monitoring is broadly defined as a way of monitor outside of conventional clinical settings (e.g. in the home) that often utilizes technology to increase access to care.

Eligible participants will be randomized into one of two groups:

* Usual Care or
* Supportive Oncology Care at Home

It is expected that about 300 people will take part in this research study.

Conditions

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Pancreatic Cancer GastroEsophageal Cancer Rectal Cancer Head and Neck Cancer Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual Care

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Standard care arm will receive standard oncology care and attend regular clinic visits.

Supportive Oncology Care at Home

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 Type EXPERIMENTAL

Supportive Oncology Care at Home

Intervention Type OTHER

Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.

Interventions

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Supportive Oncology Care at Home

Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.

Intervention Type OTHER

Usual Care

Standard care arm will receive standard oncology care and attend regular clinic visits.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medically Home

UNKNOWN

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ryan Nipp

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Nipp, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35397575 (View on PubMed)

Other Identifiers

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20-331

Identifier Type: -

Identifier Source: org_study_id

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