Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

Not Applicable

Completed

• Conditions: Cancer; Psychological Stress; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00377130
• Lead Sponsor: University of South Florida

Brief Summary

RATIONALE: A stress-management program may improve quality of life and reduce anxiety and depression in patients receiving chemotherapy for cancer.

PURPOSE: This randomized clinical trial is studying how well stress management therapy works in patients receiving chemotherapy for cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine if a self-administered stress management intervention is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in Hispanic and non-Hispanic patients receiving cancer chemotherapy.

Secondary

* Determine if the degree of acculturation in Hispanics influences the observed helpfulness of the intervention.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, use of psychotropic drugs (yes vs no), and ethnicity (Hispanic vs non-Hispanic). Patients are randomized to 1 of 2 arms.

* Arm I (self-administered stress management training plus usual psychosocial care): Patients receive a video DVD, audio CD, and brochure that provides information and instruction in 3 stress management training techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills training) to use during chemotherapy. Patients also receive usual psychosocial care.

* Arm II (usual psychosocial care only): Patients receive usual psychosocial care.

Patients complete questionnaires to assess mood, quality of life, and other factors at baseline and before chemotherapy courses 2, 3, and 4.

PROJECTED ACCRUAL: A total of 442 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-15
• Study Start: 2006-12
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-09
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life	After 4th chemotherapy cycle	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Anxiety	after 4th chemotherapy cycle	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Depression	After 4th chemotherapy cycle	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.

Secondary Outcome Measures

Name	Time	Method
Degree of acculturation	After 4th chemotherapy cycle	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.

Trial Locations

Locations (51)

Contra Costa Regional Medical Center; 🇺🇸 Martinez, California, United States

CCOP - Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

Howard University Cancer Center; 🇺🇸 Washington, District of Columbia, United States

John H. Stroger, Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

MBCCOP - JHS Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Savoy Medical Center; 🇺🇸 Mamou, Louisiana, United States

Louisiana State University Health Sciences Center - Monroe; 🇺🇸 Monroe, Louisiana, United States

Veterans Affairs Medical Center - Shreveport; 🇺🇸 Shreveport, Louisiana, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences; 🇺🇸 Shreveport, Louisiana, United States

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