Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

Depression Clinical Trial

Official title:

Stress Management Training For Patients Undergoing Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057733
• Other study ID #: MCC-0108
• Secondary ID: CDR0000069466NCI
• Status: Completed
• Phase: N/A
• First received: April 7, 2003
• Last updated: May 29, 2013
• Start date: February 2003
• Est. completion date: June 2006

Study information

• Verified date: April 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2006
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Comprehensive Cancer Care Center at Bethesda Memorial Hospital	Boynton Beach	Florida
United States	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
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	CCOP - Northwest	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Howard University Cancer Center at Howard University Hospital	Washington	District of Columbia
United States	MBCCOP - Howard University Cancer Center	Washington	District of Columbia

Sponsors (2)

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

Country where clinical trial is conducted

United States,