NCT03396510

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable cancer

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

January 3, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

4 years

First QC Date

January 3, 2018

Last Update Submit

December 21, 2022

Conditions

Cancer

Keywords

Cancer Care

Outcome Measures

Primary Outcomes (1)

  • Proportion of days with improved symptoms between study arms

    Using ESAS and PHQ symptoms, the investigators will compare the proportion of days that symptoms improved in standard care versus IMPROVED.

    2 years

Secondary Outcomes (5)

  • Proportion of days with worsened symptoms between study arms

    2 years

  • Change in patients' symptom scores from baseline to discharge

    2 years

  • Hospital length of stay (measured continuously as days admitted to the hospital) between study arms

    2 years

  • Hospital readmissions within 30 days of prior hospital discharge between study arms

    30 days

  • Hospital readmissions within 90 days of prior hospital discharge between study arms

    90 days

Other Outcomes (16)

  • Age as a moderator of the effect of IMPROVED on symptom burden

    2 years

  • Age as a moderator of the effect of IMPROVED on hospital length of stay

    2 years

  • Age as a moderator of the effect of IMPROVED on hospital readmissions

    2 years

  • +13 more other outcomes

Study Arms (2)

IMPROVED intervention

EXPERIMENTAL

Patients randomized to the IMPROVED intervention 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 study team 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 study team will not provide guidance about what actions to take in response to patients' symptoms.

Other: IMPROVED intervention

Usual Care

NO INTERVENTION

Usual Care per hospital standard will be administered. 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.

Interventions

IMPROVED interventionOTHER

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.

IMPROVED intervention

Eligibility Criteria

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

You may qualify if:

  • 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

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, 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.

    PMID: 35142814DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ryan Nipp

    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

January 3, 2018

First Posted

January 11, 2018

Study Start

February 12, 2018

Primary Completion

January 31, 2022

Study Completion

December 20, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)