Electronic Symptom Monitoring Intervention for Hospitalized Patients With Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03396510

Enrollment

390

Registered

2018-01-11

Start date

2018-02-12

Completion date

2022-12-20

Last updated

2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer 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

Interventions

OTHERIMPROVED intervention

Patients randomized to IMPROVED will self-report their symptoms each day using a tablet computer. If any patient refuses or is unable to complete the symptom assessment on the computer, the investigators will permit them to use paper versions. At morning rounds each day, the clinical team will view reports detailing their patients' symptom burden. Patients randomized to IMPROVED will have their symptoms presented to their inpatient oncology team, but the investigators will not provide guidance about what actions to take in response to patients' symptoms.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of days with improved symptoms between study arms	2 years	Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms improved in standard care versus IMPROVED.

Secondary

Measure	Time frame	Description
Proportion of days with worsened symptoms between study arms	2 years	Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms worsened in standard care versus IMPROVED.
Change in patients' symptom scores from baseline to discharge	2 years	Using ESAS and PHQ symptoms, the investigators will compare the average change in symptom burden for patients in standard care versus IMPROVED.
Hospital length of stay (measured continuously as days admitted to the hospital) between study arms	2 years	The investigators will compare hospital length of stay (measured continuously as days admitted to the hospital) between study arms.
Hospital readmissions within 30 days of prior hospital discharge between study arms	30 days	The investigators will compare readmissions within 30 days of prior hospital discharge between study arms.
Hospital readmissions within 90 days of prior hospital discharge between study arms	90 days	The investigators will compare readmissions within 90 days of prior hospital discharge between study arms.

Other

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026

Measure	Time frame	Description
Sex as a moderator of the effect of IMPROVED on hospital readmissions	2 years	The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital readmissions.
Cancer type as a moderator of the effect of IMPROVED on symptom burden	2 years	The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on symptom burden.
Cancer type as a moderator of the effect of IMPROVED on hospital readmissions	2 years	The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital readmissions.
Baseline symptom burden as a moderator of the effect of IMPROVED on hospital readmissions	2 years	The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital readmissions.
Baseline symptom burden as a moderator of the effect of IMPROVED on hospital length of stay	2 years	The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on hospital length of stay.
Cancer type as a moderator of the effect of IMPROVED on hospital length of stay	2 years	The investigators will explore cancer type as a potential moderator on the effect of IMPROVED on hospital length of stay.
Hospital length of stay as a moderator of the effect of IMPROVED on symptom burden	2 years	The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on symptom burden.
Hospital length of stay as a moderator of the effect of IMPROVED on hospital readmissions	2 years	The investigators will explore hospital length of stay as a potential moderator on the effect of IMPROVED on hospital readmissions.
Symptom burden as a mediator of the effect of IMPROVED on hospital length of stay	2 years	The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital length of stay.
Symptom burden as a mediator of the effect of IMPROVED on hospital readmissions	2 years	The investigators will explore whether improvements in symptom burden mediate the benefit of the intervention on hospital readmissions.
Baseline symptom burden as a moderator of the effect of IMPROVED on symptom burden	2 years	The investigators will explore baseline symptom burden as a potential moderator on the effect of IMPROVED on symptom burden.
Age as a moderator of the effect of IMPROVED on symptom burden	2 years	The investigators will explore age as a potential moderator on the effect of IMPROVED on symptom burden.
Age as a moderator of the effect of IMPROVED on hospital length of stay	2 years	The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital length of stay.
Age as a moderator of the effect of IMPROVED on hospital readmissions	2 years	The investigators will explore age as a potential moderator on the effect of IMPROVED on hospital readmissions.
Sex as a moderator of the effect of IMPROVED on symptom burden	2 years	The investigators will explore sex as a potential moderator on the effect of IMPROVED on symptom burden.
Sex as a moderator of the effect of IMPROVED on hospital length of stay	2 years	The investigators will explore sex as a potential moderator on the effect of IMPROVED on hospital length of stay.