Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

Cancer Clinical Trial

Official title:

Stress Management Therapy for Patients Undergoing Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377130
• Other study ID #: SCUSF 0501
• Secondary ID: SCUSF-0501HLMCC-
• Status: Completed
• Phase: N/A
• First received: September 13, 2006
• Last updated: January 30, 2014
• Start date: December 2006
• Est. completion date: May 2010

Study information

• Verified date: September 2010
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• At least 18 years of age

• Newly diagnosed with cancer

• Scheduled to receive a minimum of 4 cycles of intravenous chemotherapy

• Able and willing to give informed consent to participate

EXCLUSION CRITERIA:

• Had intravenous chemotherapy prior to study entry

• Are scheduled to receive radiotherapy prior to the end of the fourth cycle

• Have severe depression or other severe psychiatric disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Psychological Stress
• Stress, Psychological
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• Self Administered Stress Management
The SSMT kit includes a DVD and booklet will discuss the sources and manifestations of stress during chemotherapy and the potential benefits of stress management training. The videotape/DVD and booklet will also include brief instruction in paced breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements as well as recommendations for practicing the techniques before the start of chemotherapy and using them after the start of treatment. The exercise combines abbreviated progressive muscle relaxation training with use of relaxing mental imagery. The "positive thinking" exercise provides participants with brief instruction in the use of coping self-statements using techniques borrowed from stress inoculation training.

Locations

Country	Name	City	State
Puerto Rico	Andres Grillasca Hospital	Ponce
Puerto Rico	Hato Rey Hematology/Oncology Group, PSC	San Juan
Puerto Rico	I. Gonzalez Martinez Oncologic Hospital	San Juan
Puerto Rico	San Juan City Hospital	San Juan
Puerto Rico	Veterans Affairs Medical Center - San Juan	San Juan
United States	MeritCare Bemidji	Bemidji	Minnesota
United States	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Mount Carmel Hospital East	Columbus	Ohio
United States	Mount Carmel St. Ann's Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Grady Memorial Hospital	Delaware	Ohio
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	High Point Regional Hospital	High Point	North Carolina
United States	Savoy Medical Center	Mamou	Louisiana
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Bay Area Tumor Institute	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Rainier Physicians - NWMS	Puyallup	Washington
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Springfield Regional Cancer Center	Springfield	Ohio
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Scott and White Cancer Institute	Temple	Texas
United States	William Beaumont Hospital - Troy Campus	Troy	Michigan
United States	Howard University Cancer Center	Washington	District of Columbia
United States	Dickstein Cancer Treatment Center at White Plains Hospital Center	White Plains	New York
United States	Southeastern Medical Oncology Center - Wilson	Wilson	North Carolina
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.	After 4th chemotherapy cycle	No
Primary	Anxiety	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.	after 4th chemotherapy cycle	No
Primary	Depression	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.	After 4th chemotherapy cycle	No
Secondary	Degree of acculturation	Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.	After 4th chemotherapy cycle	No