Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
NCT ID: NCT00057733
Last Updated: 2013-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
INTERVENTIONAL
2003-02-28
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized clinical trial to determine the effectiveness of stress management training in helping cancer patients cope with the emotional distress of radiation therapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Meditation-Based Breathing Training in Improving Target Motion Management and Reducing Distress in Patients With Abdominal or Lung Cancer Undergoing Radiation Therapy
NCT01939210
Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
NCT00377130
Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress
NCT02988271
Effects of Mindfulness Meditation and Stress Management After Breast Cancer
NCT02119481
Music of Choice to Decrease Anxiety During Radiation Treatment
NCT03527225
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Jacobsen, PhD
Role: STUDY_CHAIR
University of South Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Howard University Cancer Center at Howard University Hospital
Washington D.C., District of Columbia, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Comprehensive Cancer Care Center at Bethesda Memorial Hospital
Boynton Beach, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Cancer Care and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
CCOP - Northwest
Tacoma, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000069466
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-5721
Identifier Type: -
Identifier Source: secondary_id
NCI-P02-0227
Identifier Type: -
Identifier Source: secondary_id
TAGH-20291
Identifier Type: -
Identifier Source: secondary_id
MCC-0108
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.