Pain and Fatigue Study

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00006253

First Posted: March 8, 2004

Last Update Posted: December 7, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Barbara Given, Michigan State University

Purpose

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:

The primary outcome--total number of symptoms reported;
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
Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.

Condition	Intervention
Carcinoma	Behavioral: Nurse Behavioral: Non-nurse coach


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care
Official Title:	Family Home Care for Cancer - A Community-Based Model

Further study details as provided by Barbara Given, Michigan State University:

Primary Outcome Measures:

Primary patient outcome
Lower reported severity of symptoms

Secondary Outcome Measures:

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


Enrollment:	350
Study Start Date:	March 2003
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nurse Receives symptom management assistance from an oncology nurse via the telephone	Behavioral: Nurse Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
Experimental: Non-nurse coach Receives symptom management assistance from a non-nurse coach via telephone	Behavioral: Non-nurse coach Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management

Detailed Description:

GOAL: The primary goal of this research is to test a symptom management intervention, delivered by nurses with special training, using a stepped-care approach targeted toward pain and fatigue, followed by fifteen other prevalent cancer symptoms. Second goals are to improve physical and social functioning, lower emotional distress, and improve communication with family caregiver in symptom management, and assist them to reduce their levels of depression and burden. This research is funded through a grant from the National Cancer Institutes, and builds upon the Family Care Research Team's program of supportive cancer-care research.

OUTCOMES: This study tests a stepped-approach intervention to determine if it improves symptom outcomes, especially pain and fatigue. Secondary outcomes addressed by the intervention are physical role impact, social functioning, and emotional distress. These outcomes can have significant impact on patients and family caregivers' well-being as patients undergo chemotherapy. The shorter, more intense intervention corresponds to changes int he clinical management of cancer patient with more intense, shorter chemotherapy treatments; therefore, this intervention will be more easily translatable to the clinical setting.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

21 years of age or older
solid tumor cancer diagnosis
receiving chemotherapy treatment
advanced cancer
family caregiver

Exclusion Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006253

Locations


United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824

Sponsors and Collaborators

Michigan State University

Investigators


Study Chair:	Barbara A. Given, PhD, RN, FAAN	Breslin Cancer Center at Ingham Regional Medical Center

More Information


Responsible Party:	Barbara Given, Associate Dean of Research, University Distinguished Professor, Michigan State University
ClinicalTrials.gov Identifier:	NCT00006253 History of Changes
Other Study ID Numbers:	R01CA079280 ( U.S. NIH Grant/Contract )
First Submitted:	September 11, 2000
First Posted:	March 8, 2004
Last Update Posted:	December 7, 2011
Last Verified:	December 2011

Keywords provided by Barbara Given, Michigan State University:


symptom management cancer chemotherapy treatment	Behavioral Research Physiological Effects of Drugs Clinical Trial, Phase II

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