NCT02891993

Brief Summary

The purpose of this research study is to address the challenge of symptom management for hospitalized patients with cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2017

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

August 27, 2016

Last Update Submit

November 19, 2021

Conditions

Cancer

Keywords

Cancer Care

Outcome Measures

Primary Outcomes (1)

  • Rates of participant completion of >2 symptom reports

    To determine rates of participant completion of \>2 symptom reports, the investigators will assess the proportion of enrolled participants who complete of \>2 symptom reports.

    2 years

Secondary Outcomes (14)

  • Rates Of Clinicians Noting Their Patients' Symptom Reports

    2 years

  • Rates Of Clinicians Developing An Action Plan In Response To Their Patients' Symptom Reports

    2 years

  • Rates Of Clinicians Discussing Their Patients' Symptom Reports

    2 years

  • Change In Patients' Symptom Scores

    2 years

  • Change In Patients' Psychological Distress

    2 years

  • +9 more secondary outcomes

Study Arms (2)

IMPROVED Intervention

EXPERIMENTAL

* Patients randomized to IMPROVED will self-report their symptoms each day using a tablet computer. * The clinical team will view reports detailing their patients' symptom burden * Clinicians will be provided with a graphic depiction of their patients' daily symptom trajectory for that admission

Other: IMPROVED

Usual Care

ACTIVE COMPARATOR

* Patients randomized to Usual Care will self-report their symptoms each day using a tablet computer * Patients will report their symptoms to their clinicians as they usually would * Clinicians will not be provided with a graphic depiction of their patients' daily symptom trajectory for that admission

Other: Usual Care

Interventions

IMPROVEDOTHER

The electronic symptom monitoring intervention, "Improving Management of Patient-Reported Outcomes Via Electronic Data (IMPROVED)," consists of patients self-reporting their symptoms each day using a tablet computer. At morning rounds each day, the clinical team will view reports detailing their patients' symptom burden.

IMPROVED Intervention
Usual CareOTHER

Participants receiving usual care will also self-report their symptoms each day using tablet computers. However, these patients' clinicians will not receive their symptom reports. Patients randomized to usual care will report their symptoms to their clinicians as they usually would, at their own discretion.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 30395144DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ryan Nipp, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 8, 2016

Study Start

September 1, 2016

Primary Completion

June 23, 2017

Study Completion

December 14, 2017

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)