Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

Study Overview
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Brief Summary
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RATIONALE: A stress-management program may improve quality of life and reduce anxiety and depression in patients receiving chemotherapy for cancer. PURPOSE: This randomized clinical trial is studying how well stress management therapy works in patients receiving chemotherapy for cancer.

Detailed Description
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OBJECTIVES: Primary 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. Secondary 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.

Official Title
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Stress Management Therapy for Patients Undergoing Chemotherapy

Conditions
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Cancer, Psychological Stress, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: Self Administered Stress Management


Participation Criteria
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Eligibility Criteria
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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 EXCLUSION CRITERIA: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm I- Usual psychological care<br>Usual psychological care- no intervention | |
| Experimental: Self administered Stress Management<br>Self-Administered Stress Management Training Plus Usual Psychosocial Care | Other: Self Administered Stress Management<br>* The SSMT kit includes a DVD and booklet will discuss the sources and manifestations of stress during chemotherapy and the potential benefits of stress management training. The videotape/DVD and booklet will also include brief instruction in paced breathing, progressive muscle relaxation with guided imagery, and use of coping self-statements as well as recommendations for practicing the techniques before the start of chemotherapy and using them after the start of treatment. The exercise combines abbreviated progressive muscle relaxation training with use of relaxing mental imagery. The positive thinking exercise provides participants with brief instruction in the use of coping self-statements using techniques borrowed from stress inoculation training.<br>* Other names: self-administered stress management training (SSMT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles. | After 4th chemotherapy cycle | 
| Anxiety | Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles. | after 4th chemotherapy cycle | 
| Depression | Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles. | After 4th chemotherapy cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of acculturation | Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles. | After 4th chemotherapy cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific