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Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT00057733
Collaborator
National Cancer Institute (NCI) (NIH)
12
Locations
40
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Stress management techniques such as muscle relaxation, guided imagery, and abdominal breathing may improve quality of life and decrease emotional distress in patients who are undergoing radiation therapy for cancer.

PURPOSE: Randomized clinical trial to determine the effectiveness of stress management training in helping cancer patients cope with the emotional distress of radiation therapy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
 N/A

Detailed Description

OBJECTIVES:

Primary

  • Determine whether a modified version of a self-administered stress management training intervention, previously found to be of benefit in chemotherapy patients, is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in patients with cancer who are undergoing radiotherapy.

Secondary

  • Compare the efficacy of this intervention on improving quality of life and decreasing psychological distress (anxiety and depression) in male vs female patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive self-administered stress management training (SSMT) in 3 stress management techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills) adapted specifically for use during radiotherapy. Patients initially receive a 5-minute standardized presentation regarding the nature and purpose of SSMT. Patients then receive information and instruction regarding the three stress management techniques comprising a videotape, audiotape, and brochure. Patients also receive their institution's usual psychosocial care.

  • Arm II: Patients receive their institution's usual psychosocial care only. Quality of life, anxiety, and depression are assessed at baseline and then at 1, 2, and 3 weeks. Intervention helpfulness is assessed at 3 weeks.

PROJECTED ACCRUAL: A total of 327 patients (approximately 163 per treatment arm) will be accrued for this study within 2 years.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Official Title:
Stress Management Training For Patients Undergoing Radiotherapy
Study Start Date :
Feb 1, 2003
Actual Primary Completion Date :
Apr 1, 2005
Actual Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Diagnosis of cancer

    • Must be scheduled to receive a minimum of 12 radiotherapy treatments over a 21-day period

    • Must not be scheduled to receive CNS irradiation

    • Must not be scheduled to receive radiotherapy as palliative care only

    • Prostate seed implants allowed

    PATIENT CHARACTERISTICS:

    Age

    • 18 and over

    Performance status

    • Not specified

    Life expectancy

    • Not specified

    Hematopoietic

    • Not specified

    Hepatic

    • Not specified

    Renal

    • Not specified

    Other

    • Able to read and speak English
    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • Not specified

    Chemotherapy

    • At least 4 weeks since prior chemotherapy

    • No concurrent cytotoxic chemotherapy

    Endocrine therapy

    • Not specified

    Radiotherapy

    • See Disease Characteristics

    • No prior radiotherapy

    Surgery

    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCOP - Western Regional, Arizona Phoenix Arizona United States 85006-2726
    2 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    3 Howard University Cancer Center at Howard University Hospital Washington District of Columbia United States 20060
    4 MBCCOP - Howard University Cancer Center Washington District of Columbia United States 20060
    5 Comprehensive Cancer Care Center at Bethesda Memorial Hospital Boynton Beach Florida United States 33435
    6 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida United States 33612-9497
    7 Cancer Care and Research Pavilion at St. Joseph's/Candler Savannah Georgia United States 31405
    8 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    9 MBCCOP-Our Lady of Mercy Cancer Center Bronx New York United States 10466
    10 CCOP - Columbus Columbus Ohio United States 43206
    11 CCOP - Scott and White Hospital Temple Texas United States 76508
    12 CCOP - Northwest Tacoma Washington United States 98405-0986

    Sponsors and Collaborators

    • University of South Florida
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Paul Jacobsen, PhD, University of South Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00057733
    Other Study ID Numbers:
    • MCC-0108
    • CDR0000069466
    • NCI-5721
    • NCI-P02-0227
    • TAGH-20291
    First Posted:
    Apr 9, 2003
    Last Update Posted:
    May 30, 2013
    Last Verified:
    Apr 1, 2005
    Keywords provided by , ,
    anxiety disorder
    depression
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Depression
    Anxiety Disorders

    Study Results

    No Results Posted as of May 30, 2013