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Stress Management Therapy for Patients Undergoing Chemotherapy

18 Years
Not Enrolling
Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Stress Management Therapy for Patients Undergoing Chemotherapy



- Determine if a self-administered stress management intervention is effective in
improving quality of life and decreasing psychological distress (anxiety and
depression) in Hispanic and non-Hispanic patients receiving cancer chemotherapy.


- Determine if the degree of acculturation in Hispanics influences the observed
helpfulness of the intervention.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, use of psychotropic drugs (yes vs no), and ethnicity (Hispanic vs
non-Hispanic). Patients are randomized to 1 of 2 arms.

- Arm I (self-administered stress management training plus usual psychosocial care):
Patients receive a video DVD, audio CD, and brochure that provides information and
instruction in 3 stress management training techniques (progressive muscle relaxation
training and guided imagery, abdominal breathing, and coping skills training) to use
during chemotherapy. Patients also receive usual psychosocial care.

- Arm II (usual psychosocial care only): Patients receive usual psychosocial care.

Patients complete questionnaires to assess mood, quality of life, and other factors at
baseline and before chemotherapy courses 2, 3, and 4.

PROJECTED ACCRUAL: A total of 442 patients will be accrued for this study.

Inclusion Criteria


- At least 18 years of age

- Newly diagnosed with cancer

- Scheduled to receive a minimum of 4 cycles of intravenous chemotherapy

- Able and willing to give informed consent to participate


- Had intravenous chemotherapy prior to study entry

- Are scheduled to receive radiotherapy prior to the end of the fourth cycle

- Have severe depression or other severe psychiatric disorders

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Quality of life

Outcome Description:

Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.

Outcome Time Frame:

After 4th chemotherapy cycle

Safety Issue:


Principal Investigator

Teletia Taylor, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Howard University Cancer Center


United States: Federal Government

Study ID:

SCUSF 0501



Start Date:

December 2006

Completion Date:

Related Keywords:

  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • psychosocial effects of cancer and its treatment
  • unspecified adult solid tumor, protocol specific



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