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Stress Management Training For Patients Undergoing Radiotherapy


N/A
18 Years
N/A
Not Enrolling
Both
Anxiety Disorder, Depression, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Stress Management Training For Patients Undergoing Radiotherapy


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized

Principal Investigator

Paul Jacobsen, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of South Florida

Authority:

United States: Federal Government

Study ID:

MCC-0108

NCT ID:

NCT00057733

Start Date:

February 2003

Completion Date:

June 2006

Related Keywords:

  • Anxiety Disorder
  • Depression
  • Unspecified Adult Solid Tumor, Protocol Specific
  • anxiety disorder
  • depression
  • unspecified adult solid tumor, protocol specific
  • Anxiety Disorders
  • Depression
  • Depressive Disorder

Name

Location

CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - NorthwestTacoma, Washington  98405-0986
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Cancer Care and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405-6013
Howard University Cancer Center at Howard University HospitalWashington, District of Columbia  20060
Comprehensive Cancer Care Center at Bethesda Memorial HospitalBoynton Beach, Florida  33435