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Pain and Fatigue Study

NCT ID: NCT00006253

Last Updated: 2011-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Carcinoma

Keywords

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symptom management cancer chemotherapy treatment Behavioral Research Physiological Effects of Drugs Clinical Trial, Phase II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Nurse

Receives symptom management assistance from an oncology nurse via the telephone

Group Type EXPERIMENTAL

Nurse

Intervention Type BEHAVIORAL

Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management

Non-nurse coach

Receives symptom management assistance from a non-nurse coach via telephone

Group Type EXPERIMENTAL

Non-nurse coach

Intervention Type BEHAVIORAL

Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management

Interventions

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Nurse

Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management

Intervention Type BEHAVIORAL

Non-nurse coach

Receives 6 telephone calls over 8 weeks from a non-nurse coach to assist with symptom management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Barbara Given

Associate Dean of Research, University Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara A. Given, PhD, RN, FAAN

Role: STUDY_CHAIR

Breslin Cancer Center at Ingham Regional Medical Center

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R01CA079280

Identifier Type: NIH

Identifier Source: org_study_id

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