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Home-Based Supportive Care for Cancer

N/A

Waitlist Available

Led By Ryan Nipp, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be age 18 or older

Receiving definitive treatment (i.e. neoadjuvant chemotherapy and/or chemoradiation with curative intent) for pancreatic, gastroesophageal, rectal, or head and neck cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

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.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on supportive care rather than direct medical treatments, side effects may not be as prominent but could include discomfort from remote monitoring devices or stress related to participation in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of participants requiring a hospital admission or emergency department visit

Secondary outcome measures

Change in Activities of Daily Living (ADLs)

Change in Instrumental Activities of Daily Living (IADLs)

Change in care satisfaction (FAMCARE)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Supportive Oncology Care at HomeExperimental Treatment1 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 CareActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medically HomeUNKNOWN

1 Previous Clinical Trials

105 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,055 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

Media Library

Supportive Oncology Care at Home Clinical Trial Eligibility Overview. Trial Name: NCT04544046 — N/A

Gastroesophageal Cancer Research Study Groups: Supportive Oncology Care at Home, Usual Care

Gastroesophageal Cancer Clinical Trial 2023: Supportive Oncology Care at Home Highlights & Side Effects. Trial Name: NCT04544046 — N/A

Supportive Oncology Care at Home 2023 Treatment Timeline for Medical Study. Trial Name: NCT04544046 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are participants engaging in this experiment?

"Affirmative. Clinicaltrials.gov data indicates that, as of November 18th 2022, this medical trial is still recruiting patients. Originally posted on September 16th 2020, the study aims to recruit 300 people from a single site."

Answered by AI

Is this trial accepting new participants at the present time?

"Affirmative, clinicaltrials.gov confirms that this research experiment is in the process of recruitment. It was first posted on September 16th 2020 and most recently edited on November 18th 2022. 300 individuals are needed from a single medical centre for enrolment into the trial."

Answered by AI

Recent research and studies

BMC CancerJournal

Supportive Oncology Care at Home Interventions: Protocols for Clinical Trials to Shift the Paradigm of Care for Patients with Cancer

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.

clinicaltrials.govStudy

Supportive Oncology Care At Home RCT

Ryan Nipp 2020. "Supportive Oncology Care At Home RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04544046.

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