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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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CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
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CCOP - Northwest Tacoma, Washington  98405-0986
CCOP - Beaumont Royal Oak, Michigan  48073-6769
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
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Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx, New York  10466
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Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Howard University Cancer Center Washington, District of Columbia  20060
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Louisiana State University Health Sciences Center - Monroe Monroe, Louisiana  71210
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport, Louisiana  71130-3932
Iredell Memorial Hospital Statesville, North Carolina  28677
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Grant Medical Center Cancer Care Columbus, Ohio  43215
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Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
Scott and White Cancer Institute Temple, Texas  76508
Southeastern Medical Oncology Center - Wilson Wilson, North Carolina  27893
Savoy Medical Center Mamou, Louisiana  70554
Dickstein Cancer Treatment Center at White Plains Hospital Center White Plains, New York  10601
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Rainier Physicians - NWMS Puyallup, Washington  98372