Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

January 30, 2014 updated by: University of South Florida

Stress Management Therapy for Patients Undergoing Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

442

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00733-1324
        • Andres Grillasca Hospital
      • San Juan, Puerto Rico, 00936-7344
        • San Juan City Hospital
      • San Juan, Puerto Rico, 00927-5800
        • Veterans Affairs Medical Center - San Juan
      • San Juan, Puerto Rico, 00917-5025
        • Hato Rey Hematology/Oncology Group, PSC
      • San Juan, Puerto Rico, 00919-1811
        • I. Gonzalez Martinez Oncologic Hospital
  • United States
    • California
      • Martinez, California, United States, 94553
        • Contra Costa Regional Medical Center
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612-9985
        • John H. Stroger, Jr. Hospital of Cook County
      • Chicago, Illinois, United States, 60612
        • MBCCOP - JHS Hospital of Cook County
    • Louisiana
      • Mamou, Louisiana, United States, 70554
        • Savoy Medical Center
      • Monroe, Louisiana, United States, 71210
        • Louisiana State University Health Sciences Center - Monroe
      • Shreveport, Louisiana, United States, 71130-3932
        • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
      • Shreveport, Louisiana, United States, 71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Royal Oak, Michigan, United States, 48073
        • CCOP - Beaumont
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital - Troy Campus
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Bemidji
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
      • Springfield, Missouri, United States, 65804
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804-2263
        • St. John's Regional Health Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Bronx, New York, United States, 10466-2604
        • Our Lady of Mercy Medical Center Comprehensive Cancer Center
      • White Plains, New York, United States, 10601
        • Dickstein Cancer Treatment Center at White Plains Hospital Center
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center - Goldsboro
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Memorial Hospital
      • High Point, North Carolina, United States, 27262
        • High Point Regional Hospital
      • Statesville, North Carolina, United States, 28687-1828
        • Iredell Memorial Hospital
      • Wilson, North Carolina, United States, 27893
        • Southeastern Medical Oncology Center - Wilson
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Regional Cancer Center at Forsyth Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Cancer Center at MeritCare Hospital
    • Ohio
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital at Ohio Health
      • Columbus, Ohio, United States, 43215
        • Mount Carmel Hospital East
      • Columbus, Ohio, United States, 43222
        • Mount Carmel St. Ann's Cancer Center
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Marietta, Ohio, United States, 45750-1635
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Newark, Ohio, United States, 43055-2899
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Springfield, Ohio, United States, 45504
        • Springfield Regional Cancer Center
      • Zanesville, Ohio, United States, 43701
        • Genesis - Good Samaritan Hospital
    • Texas
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
      • Temple, Texas, United States, 76508
        • Scott and White Cancer Institute
    • Washington
      • Puyallup, Washington, United States, 98372
        • Rainier Physicians - NWMS
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm I- Usual psychological care
Usual psychological care- no intervention
Experimental: Self administered Stress Management
Self-Administered Stress Management Training Plus Usual Psychosocial Care
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.
Other Names:
  • self-administered stress management training (SSMT)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of acculturation
Time Frame: After 4th chemotherapy cycle
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
After 4th chemotherapy cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Teletia Taylor, PhD, Howard University Cancer Center
  • Study Chair: Susan McMillan, PhD RN FAAN, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCUSF 0501
  • 5U10CA081920-11 (U.S. NIH Grant/Contract)
  • SCUSF-0501 (Other Identifier: SunCoast CCOP Research Base)
  • HLMCC-0501 (Other Identifier: H. Lee Moffitt Cancer Center Research Base)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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