NCT00799084

Brief Summary

To improve the management of symptoms, patients with cancer undergoing chemotherapy will be monitored using an automated telephone system to record the severity of 15 prevalent symptoms for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity and improvement in health states.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
526

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2003

Typical duration for phase_2

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

Study Start

First participant enrolled

April 1, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

Enrollment Period

3.6 years

First QC Date

November 25, 2008

Last Update Submit

December 6, 2011

Conditions

Carcinoma

Keywords

symptom managementcancerchemotherapy treatmentBehavioral ResearchPhysiological Effects of DrugsClinical Trial, Phase II

Outcome Measures

Primary Outcomes (1)

  • Lower reported mean severity index among 7 prevalent symptoms

    9 weeks, 15 weeks

Secondary Outcomes (1)

  • Reduced impact of physical role performance, improved social functioning, and reduced emotional distress; improved levels of communication between patients and providers; and improved patient satisfaction with care.

    9 weeks, 15 weeks

Study Arms (2)

Nurse

EXPERIMENTAL

Receives symptom management assistance from an oncology nurse via the telephone

Behavioral: Nurse

AVR

EXPERIMENTAL

Receives symptom management assistance from an Automated telephone system

Behavioral: AVR

Interventions

NurseBEHAVIORAL

Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management

Nurse
AVRBEHAVIORAL

Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management

AVR

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • solid tumor cancer diagnosis
  • receiving chemotherapy treatment

You may not qualify if:

  • Emotional or psychology disorder for which patient is receiving treatment
  • does not speak English
  • does not have access to a telephone
  • difficulty hearing on the telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

CarcinomaNeoplasms

Interventions

Nurses

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Charles Given, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2008

First Posted

November 27, 2008

Study Start

April 1, 2003

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations

US(1)