Clinical trial NCT02891993: Pilot Study of a Symptom Monitoring Intervention for Hospitalized Patients With Cancer
Official title: Pilot Study of a 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
First posted: 2016-09-08
Enrollment: 150
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: The purpose of this research study is to address the challenge of symptom management for hospitalized patients with cancer.

Detailed description: Patients with cancer may experience a considerable symptom burden, often requiring hospitalizations for symptom management. This study will pilot test an electronic symptom monitoring intervention, "Improving Management of Patient-Reported Outcomes Via Electronic Data (IMPROVED)," versus usual care in hospitalized patients with cancer.

The goal of this study is test a model where patients' symptoms are monitored during their hospital admission electronically via tablet computers. 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 takes place at Massachusetts General Hospital 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 incurable cancer (defined as receiving treatment with palliative intent as per chemotherapy order entry designation, trial consent forms, or not receiving chemotherapy but followed for incurable disease as per oncology clinic notes)
* Admitted to Lunder 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: Rates of participant completion of >2 symptom reports
timeFrame: 2 years
Secondary outcomes:
measure: Rates Of Clinicians Noting Their Patients' Symptom Reports
timeFrame: 2 years
measure: Rates Of Clinicians Developing An Action Plan In Response To Their Patients' Symptom Reports
timeFrame: 2 years
measure: Rates Of Clinicians Discussing Their Patients' Symptom Reports
timeFrame: 2 years
measure: Change In Patients' Symptom Scores
timeFrame: 2 years
measure: Change In Patients' Psychological Distress
timeFrame: 2 years
measure: Change In Patients' Depression Scores
timeFrame: 2 years
measure: Change In Patients' Anxiety Scores
timeFrame: 2 years
measure: Rates Of Moderate/Severe Symptoms
timeFrame: 2 years
measure: Rates Of Depression Symptoms
timeFrame: 2 years
measure: Rates Of Anxiety Symptoms
timeFrame: 2 years
measure: Rates Of Moderate/Severe Psychological Symptoms
timeFrame: 2 years
measure: Rates Of Patient Satisfaction
timeFrame: 2 years
measure: Hospital Length Of Stay
timeFrame: 2 years
measure: 30-Day Readmissions Rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Nipp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nipp RD, El-Jawahri A, Ruddy M, Fuh C, Temel B, D'Arpino SM, Cashavelly BJ, Jackson VA, Ryan DP, Hochberg EP, Greer JA, Temel JS. Pilot randomized trial of an electronic symptom monitoring intervention for hospitalized patients with cancer. Ann Oncol. 2019 Feb 1;30(2):274-280. doi: 10.1093/annonc/mdy488.