Clinical trial NCT03396510: Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Official title: Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Alliance for Clinical Trials in Oncology Cancer Control Program (CCP)
First posted: 2018-01-11
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is evaluating a new way to deliver oncology care for patients with cancer

Detailed description: Patients with cancer may experience a considerable symptom burden, often requiring hospitalizations for symptom management. The study doctors want to know if daily electronic monitoring of the symptoms, such as pain, nausea, constipation, and diarrhea may improve care while participants are hospitalized.

The goal of this study is to evaluate a new way to deliver oncology care where patients' symptoms are systematically monitored during their hospital admission. The investigators are studying whether patients whose clinicians receive their patients' detailed symptom reports each day have improved symptom management compared to those whose clinicians do not receive their patients' detailed symptom reports each day.

The study will use questionnaires to measure the participant symptoms and involves participating in a study for as long as the participants are admitted to the hospital. The information the investigators collect will help them determine if electronic symptom monitoring improves the care of patients with cancer

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosed with advanced cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, oncology clinic notes, and/or trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
* Admitted to the oncology service at Massachusetts General Hospital
* Verbal fluency in English

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Admitted electively
* Participated during a previous admission

Primary outcomes:
measure: Proportion of days with improved symptoms between study arms
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of days with worsened symptoms between study arms
timeFrame: 2 years
measure: Change in patients' symptom scores from baseline to discharge
timeFrame: 2 years
measure: Hospital length of stay (measured continuously as days admitted to the hospital) between study arms
timeFrame: 2 years
measure: Hospital readmissions within 30 days of prior hospital discharge between study arms
timeFrame: 30 days
measure: Hospital readmissions within 90 days of prior hospital discharge between study arms
timeFrame: 90 days
Other outcomes:
measure: Age as a moderator of the effect of IMPROVED on symptom burden
timeFrame: 2 years
measure: Age as a moderator of the effect of IMPROVED on hospital length of stay
timeFrame: 2 years
measure: Age as a moderator of the effect of IMPROVED on hospital readmissions
timeFrame: 2 years
measure: Sex as a moderator of the effect of IMPROVED on symptom burden
timeFrame: 2 years
measure: Sex as a moderator of the effect of IMPROVED on hospital length of stay
timeFrame: 2 years
measure: Sex as a moderator of the effect of IMPROVED on hospital readmissions
timeFrame: 2 years
measure: Cancer type as a moderator of the effect of IMPROVED on symptom burden
timeFrame: 2 years
measure: Cancer type as a moderator of the effect of IMPROVED on hospital readmissions
timeFrame: 2 years
measure: Cancer type as a moderator of the effect of IMPROVED on hospital length of stay
timeFrame: 2 years
measure: Baseline symptom burden as a moderator of the effect of IMPROVED on hospital readmissions
timeFrame: 2 years
measure: Baseline symptom burden as a moderator of the effect of IMPROVED on hospital length of stay
timeFrame: 2 years
measure: Baseline symptom burden as a moderator of the effect of IMPROVED on symptom burden
timeFrame: 2 years
measure: Hospital length of stay as a moderator of the effect of IMPROVED on symptom burden
timeFrame: 2 years
measure: Hospital length of stay as a moderator of the effect of IMPROVED on hospital readmissions
timeFrame: 2 years
measure: Symptom burden as a mediator of the effect of IMPROVED on hospital length of stay
timeFrame: 2 years
measure: Symptom burden as a mediator of the effect of IMPROVED on hospital readmissions
timeFrame: 2 years
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Nipp
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nipp RD, Horick NK, Qian CL, Knight HP, Kaslow-Zieve ER, Azoba CC, Elyze M, Landay SL, Kay PS, Ryan DP, Jackson VA, Greer JA, El-Jawahri A, Temel JS. Effect of a Symptom Monitoring Intervention for Patients Hospitalized With Advanced Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):571-578. doi: 10.1001/jamaoncol.2021.7643.