Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

University of South Florida

Status: Completed

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

Treatments: Other: Self Administered Stress Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00377130

SCUSF 0501

5U10CA081920-11 (U.S. NIH Grant/Contract)

HLMCC-0501 (Other Identifier)

SCUSF-0501 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 442 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

442 participants in 2 patient groups

Arm I- Usual psychological care

No Intervention group

Description:

Usual psychological care- no intervention

Self administered Stress Management

Experimental group

Description:

Self-Administered Stress Management Training Plus Usual Psychosocial Care

Treatment:

Other: Self Administered Stress Management