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

September 11, 2000
December 6, 2011
March 2003
October 2006   (final data collection date for primary outcome measure)
Primary patient outcome
Lower reported severity of symptoms
Not Provided
Complete list of historical versions of study NCT00006253 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Pain and Fatigue Study
Family Home Care for Cancer - A Community-Based Model

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Carcinoma
  • Behavioral: Nurse
    Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
  • Behavioral: Non-nurse coach
    Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management
  • Experimental: Nurse
    Receives symptom management assistance from an oncology nurse via the telephone
    Intervention: Behavioral: Nurse
  • Experimental: Non-nurse coach
    Receives symptom management assistance from a non-nurse coach via telephone
    Intervention: Behavioral: Non-nurse coach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006253
R01CA79280
No
Barbara Given, Michigan State University
Michigan State University
Not Provided
Study Chair: Barbara A. Given, PhD, RN, FAAN Breslin Cancer Center at Ingham Regional Medical Center
Michigan State University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP