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Pain and Fatigue Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbara Given, Michigan State University
ClinicalTrials.gov Identifier:
NCT00006253
First received: September 11, 2000
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  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:

  1. The primary outcome--total number of symptoms reported;
  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. 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: Open Label
Primary Purpose: Supportive Care
Official Title: Family Home Care for Cancer - A Community-Based Model

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

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: R01CA79280
Study First Received: September 11, 2000
Last Updated: December 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Michigan State University:
symptom management
cancer
chemotherapy treatment
 Behavioral Research
Physiological Effects of Drugs
Clinical Trial, Phase II

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013