Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain and Fatigue Study

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.
 
ClinicalTrials.gov Identifier: NCT00006253
Recruitment Status : Completed
First Posted : March 8, 2004
Last Update Posted : December 7, 2011
Sponsor:
Information provided by (Responsible Party):
Barbara Given, Michigan State University

Tracking Information
First Submitted Date  ICMJE September 11, 2000
First Posted Date  ICMJE March 8, 2004
Last Update Posted Date December 7, 2011
Study Start Date  ICMJE March 2003
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
Primary patient outcome
Lower reported severity of symptoms
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain and Fatigue Study
Official Title  ICMJE Family Home Care for Cancer - A Community-Based Model
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. 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2011)
350
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006253
Other Study ID Numbers  ICMJE R01CA079280( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara Given, Michigan State University
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Barbara A. Given, PhD, RN, FAAN Breslin Cancer Center at Ingham Regional Medical Center
PRS Account Michigan State University
Verification Date December 2011

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