Clinical trial NCT00377130: Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
Official title: Stress Management Therapy for Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Psychological Stress
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-15
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: After 4th chemotherapy cycle
measure: Anxiety
timeFrame: after 4th chemotherapy cycle
measure: Depression
timeFrame: After 4th chemotherapy cycle
Secondary outcomes:
measure: Degree of acculturation
timeFrame: After 4th chemotherapy cycle
Other outcomes:
Locations:
city: Martinez
country: United States
facility: Contra Costa Regional Medical Center
state: California
city: Oakland
country: United States
facility: CCOP - Bay Area Tumor Institute
state: California
city: Oakland
country: United States
facility: Bay Area Tumor Institute
state: California
city: Washington
country: United States
facility: Howard University Cancer Center
state: District of Columbia
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: MBCCOP - JHS Hospital of Cook County
state: Illinois
city: Mamou
country: United States
facility: Savoy Medical Center
state: Louisiana
city: Monroe
country: United States
facility: Louisiana State University Health Sciences Center - Monroe
state: Louisiana
city: Shreveport
country: United States
facility: Veterans Affairs Medical Center - Shreveport
state: Louisiana
city: Shreveport
country: United States
facility: Feist-Weiller Cancer Center at Louisiana State University Health Sciences
state: Louisiana
city: Royal Oak
country: United States
facility: CCOP - Beaumont
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy Campus
state: Michigan
city: Bemidji
country: United States
facility: MeritCare Bemidji
state: Minnesota
city: Springfield
country: United States
facility: St. John's Regional Health Center
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: Springfield
country: United States
facility: Hulston Cancer Center at Cox Medical Center South
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Our Lady of Mercy Medical Center Comprehensive Cancer Center
state: New York
city: White Plains
country: United States
facility: Dickstein Cancer Treatment Center at White Plains Hospital Center
state: New York
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center - Goldsboro
state: North Carolina
city: Hendersonville
country: United States
facility: Pardee Memorial Hospital
state: North Carolina
city: High Point
country: United States
facility: High Point Regional Hospital
state: North Carolina
city: Statesville
country: United States
facility: Iredell Memorial Hospital
state: North Carolina
city: Wilson
country: United States
facility: Southeastern Medical Oncology Center - Wilson
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Regional Cancer Center at Forsyth Medical Center
state: North Carolina
city: Fargo
country: United States
facility: CCOP - MeritCare Hospital
state: North Dakota
city: Fargo
country: United States
facility: Roger Maris Cancer Center at MeritCare Hospital
state: North Dakota
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital Cancer Care
state: Ohio
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center Cancer Care
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Hospital East
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health - West Hospital
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel St. Ann's Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Doctors Hospital at Ohio Health
state: Ohio
city: Delaware
country: United States
facility: Grady Memorial Hospital
state: Ohio
city: Marietta
country: United States
facility: Strecker Cancer Center at Marietta Memorial Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Cancer Care Program at Licking Memorial Hospital
state: Ohio
city: Springfield
country: United States
facility: Springfield Regional Cancer Center
state: Ohio
city: Zanesville
country: United States
facility: Genesis - Good Samaritan Hospital
state: Ohio
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
city: Temple
country: United States
facility: Scott and White Cancer Institute
state: Texas
city: Puyallup
country: United States
facility: Rainier Physicians - NWMS
state: Washington
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
city: Ponce
country: Puerto Rico
facility: Andres Grillasca Hospital
city: San Juan
country: Puerto Rico
facility: Hato Rey Hematology/Oncology Group, PSC
city: San Juan
country: Puerto Rico
facility: I. Gonzalez Martinez Oncologic Hospital
city: San Juan
country: Puerto Rico
facility: Veterans Affairs Medical Center - San Juan
city: San Juan
country: Puerto Rico
facility: San Juan City Hospital
Study officials:
affiliation: Howard University Cancer Center
name: Teletia Taylor, PhD
role: STUDY_CHAIR
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Susan McMillan, PhD RN FAAN
role: STUDY_CHAIR
References: