NCT00006253

Brief Summary

Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care. When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following:

  1. 1.The primary outcome--total number of symptoms reported;
  2. 2.The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and
  3. 3.Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable

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

September 11, 2000

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 1, 2003

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 8, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 7, 2011

Status Verified

December 1, 2011

Enrollment Period

3.6 years

First QC Date

September 11, 2000

Last Update Submit

December 6, 2011

Conditions

Carcinoma

Keywords

symptom managementcancerchemotherapy treatmentBehavioral ResearchPhysiological Effects of DrugsClinical Trial, Phase II

Outcome Measures

Primary Outcomes (1)

  • Primary patient outcome

    Lower reported severity of symptoms

Secondary Outcomes (1)

  • Secondary Patient Outcomes

Study Arms (2)

Nurse

EXPERIMENTAL

Receives symptom management assistance from an oncology nurse via the telephone

Behavioral: Nurse

Non-nurse coach

EXPERIMENTAL

Receives symptom management assistance from a non-nurse coach via telephone

Behavioral: Non-nurse coach

Interventions

NurseBEHAVIORAL

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

Nurse
Non-nurse coachBEHAVIORAL

Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management

Non-nurse coach

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
  • advanced cancer
  • family caregiver

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

  • Barbara A. Given, PhD, RN, FAAN

    Breslin Cancer Center at Ingham Regional Medical Center

    STUDY CHAIR

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
Associate Dean of Research, University Distinguished Professor

Study Record Dates

First Submitted

September 11, 2000

First Posted

March 8, 2004

Study Start

March 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

December 7, 2011

Record last verified: 2011-12

Locations

US(1)