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NCT Number: NCT04544046

Supportive Oncology Care At Home RCT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases GastroEsophageal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supportive Oncology Care at Home

Other

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

Usual Care

Other

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

Primary outcomes

  1. Proportion of participants requiring a hospital admission or emergency department visit

    Time frame: baseline to 6 months

    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).

Secondary outcomes

  1. Proportion of days participants spend outside of the hospital during the study period

    Time frame: baseline to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  2. Proportion of patients needing an urgent visit to clinic

    Time frame: baseline to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  3. Rate of treatment delays

    Time frame: baseline to 6 months

    Compare rates of treatment interruptions (e.g. delays) 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).

  4. Comparison of dose intensity

    Time frame: baseline to 6 months

    Compare dose intensity using linear regression or Poisson regression based on normality of the data adjusted for any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  5. Change in symptom burden (ESAS)

    Time frame: baseline up to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  6. Change in quality of life (FACT-G)

    Time frame: baseline to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  7. Change in psychological distress (HADS)

    Time frame: baseline to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  8. Change in care satisfaction (FAMCARE)

    Time frame: baseline to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  9. Change in Activities of Daily Living (ADLs)

    Time frame: baseline to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).

  10. Change in Instrumental Activities of Daily Living (IADLs)

    Time frame: baseline to 6 months

    Linear regression or Poisson regression based on normality of the data adjusted for baseline values of each respective patient-reported outcome and any potential confounders that are imbalanced between the two groups (e.g. age, gender).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Medically Home

Registry information

Official study title

Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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