Pain and Fatigue Study

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Carcinoma	Behavioral: Nurse; Behavioral: Non-nurse coach	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 350 participants
• 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
• Study Start Date: March 2003
• Actual Primary Completion Date: October 2006
• Actual Study Completion Date: October 2006

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Primary patient outcome
   Lower reported severity of symptoms

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: R01CA079280 ( U.S. NIH Grant/Contract )
• 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