NCT00852852

Brief Summary

This research study will test a new online computer program for patients, the Electronic Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and quality of life issues and learn information about how to deal with these experiences. The computer program is being tested to see if it can improve communications between patients and their care team and if it can improve patients' experiences during and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
779

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

2.7 years

First QC Date

February 26, 2009

Last Update Submit

January 30, 2018

Conditions

Cancer

Keywords

ESRA-C 2computerized assessment

Outcome Measures

Primary Outcomes (1)

  • Symptom burden and quality of life 2-4 weeks post treatment

    3 years

Secondary Outcomes (1)

  • To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings.

    3 years

Study Arms (2)

Intervention

EXPERIMENTAL

Patient participants in the intervention arm can access educational information about self-care strategies, track and share reports of their symptoms and quality of life issues over time, and receive coaching on how to discuss these issues with their care team.

Behavioral: Electronic Self-Report Assessment - Cancer (ESRA-C)

Control

NO INTERVENTION

Participants in the control arm access the ESRA-C from home or clinic to self-assess only.

Interventions

Electronic Self-Report Assessment - Cancer (ESRA-C)BEHAVIORAL

The Electronic Self-Report Assessment-Cancer (ESRA-C) is a program allowing patients to report symptoms and quality of life issues and learn information about how to deal with these experiences.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligible clinician participants (Inclusion): * Nurses, physicians, or physician assistants * Perform consults/exams in clinics that have implemented routine use of the ESRA-C 2 screening tool as a standard of care Eligible patient participants (Inclusion): * 18 years of age or older * Diagnosis of malignant disease * Plan to have treatment in a study clinic * Speak and read English at a 6th grade level or higher

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Washington Medical Center

Seattle, Washington, 98115, United States

Location

Related Publications (6)

  • Knoerl R, Hong F, Blonquist T, Berry D. Impact of Electronic Self-Assessment and Self-Care Technology on Adherence to Clinician Recommendations and Self-Management Activity for Cancer Treatment-Related Symptoms: Secondary Analysis of a Randomized Controlled Trial. JMIR Cancer. 2019 Jan 8;5(1):e11395. doi: 10.2196/11395.

    PMID: 30622093DERIVED

  • Knoerl R, Weller E, Halpenny B, Berry D. Exploring the efficacy of an electronic symptom assessment and self-care intervention to preserve physical function in individuals receiving neurotoxic chemotherapy. BMC Cancer. 2018 Dec 4;18(1):1203. doi: 10.1186/s12885-018-5093-z.

    PMID: 30514351DERIVED

  • Siefert ML, Bonquist TM, Berry DL, Hong F. Symptom-related emergency department visits and hospital admissions during ambulatory cancer treatment. J Community Support Oncol. 2015 May;13(5):188-94. doi: 10.12788/jcso.0134.

    PMID: 27119127DERIVED

  • Berry DL, Blonquist TM, Patel RA, Halpenny B, McReynolds J. Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress. J Med Internet Res. 2015 Jun 3;17(6):e136. doi: 10.2196/jmir.4190.

    PMID: 26041682DERIVED

  • Berry DL, Hong F, Halpenny B, Partridge A, Fox E, Fann JR, Wolpin S, Lober WB, Bush N, Parvathaneni U, Amtmann D, Ford R. The electronic self report assessment and intervention for cancer: promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial. BMC Cancer. 2014 Jul 12;14:513. doi: 10.1186/1471-2407-14-513.

    PMID: 25014995DERIVED

  • Hong F, Bosco JL, Bush N, Berry DL. Patient self-appraisal of change and minimal clinically important difference on the European organization for the research and treatment of cancer quality of life questionnaire core 30 before and during cancer therapy. BMC Cancer. 2013 Mar 28;13:165. doi: 10.1186/1471-2407-13-165.

    PMID: 23537330DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Donna L. Berry

    Dana-Farber Cancer Institute

    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
Assoc. Professor, Harvard Medical School; Director, The Phyllis F. Cantor Center, Research in Nursing and Patient Care Services; Affiliate Professor, University of Washington School of Nursing

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

December 1, 2013

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)