Stress Management Therapy in Patients Receiving Chemotherapy for Cancer - Full Text View

Sponsors and Collaborators:	H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00377130

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific	Procedure: counseling Procedure: management of therapy complications Procedure: mind-body intervention procedure Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: study of socioeconomic and demographic variables

MedlinePlus related topics: Anxiety Cancer Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized
Official Title:	Stress Management Therapy for Patients Undergoing Chemotherapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Quality of life [ Designated as safety issue: No ]
Anxiety [ Designated as safety issue: No ]
Depression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Degree of acculturation [ Designated as safety issue: No ]

Estimated Enrollment:	442
Study Start Date:	December 2006
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed with cancer
Scheduled to receive ≥ 4 courses of intravenous chemotherapy
- Not scheduled to receive radiotherapy prior to the end of course 4
No severe depression or other severe psychiatric disorders

PATIENT CHARACTERISTICS:

Able to read and speak English or Spanish

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior intravenous chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377130

Show 53 Study Locations

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:	Teletia Taylor, PhD	Howard University Cancer Center
Investigator:	Susan McMillan, PhD, RN, FAAN	H. Lee Moffitt Cancer Center and Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000485314, MCC-0501
Study First Received:	September 13, 2006
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00377130
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

psychosocial effects/treatment
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Stress

ClinicalTrials.gov processed this record on January 15, 2009