Stress Management Training in Patients Undergoing Radiation Therapy for Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

April 7, 2003

Last Updated Date

August 19, 2009

Start Date ^ICMJE

February 2003

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00057733 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

Official Title ^ICMJE

Stress Management Training For Patients Undergoing Radiotherapy

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Active Control

Condition ^ICMJE

Anxiety Disorder
Depression
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00057733

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069466, MCC-0108, NCI-5721, NCI-P02-0227, TAGH-20291

Study Sponsor ^ICMJE

H. Lee Moffitt Cancer Center and Research Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Paul Jacobsen, PhD

H. Lee Moffitt Cancer Center and Research Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP