NCT00057733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 30, 2013

Status Verified

April 1, 2005

Enrollment Period

2.2 years

First QC Date

April 7, 2003

Last Update Submit

May 29, 2013

Conditions

Anxiety DisorderDepressionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

anxiety disorderdepressionunspecified adult solid tumor, protocol specific

Interventions

psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Howard University Cancer Center at Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Comprehensive Cancer Care Center at Bethesda Memorial Hospital

Boynton Beach, Florida, 33435, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Cancer Care and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

MBCCOP-Our Lady of Mercy Cancer Center

The Bronx, New York, 10466, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Paul Jacobsen, PhD

    University of South Florida

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

February 1, 2003

Primary Completion

April 1, 2005

Study Completion

June 1, 2006

Last Updated

May 30, 2013

Record last verified: 2005-04

Locations

US(12)