Pain and Fatigue Study

Carcinoma Clinical Trial

Official title:

Family Home Care for Cancer - A Community-Based Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006253
• Other study ID #: R01CA079280
• Status: Completed
• Phase: N/A
• First received: September 11, 2000
• Last updated: December 6, 2011
• Start date: March 2003
• Est. completion date: October 2006

Study information

• Verified date: December 2011
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma

Intervention

Behavioral:
• Nurse
Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
• Non-nurse coach
Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patient outcome	Lower reported severity of symptoms
Secondary	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