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

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
Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific	Other: Self Administered Stress Management Training

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Stress Management Therapy for Patients Undergoing Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Depression

U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:

Quality of life [ Time Frame: After 4th chemotherapy cycle ] [ Designated as safety issue: No ]
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Anxiety [ Time Frame: after 4th chemotherapy cycle ] [ Designated as safety issue: No ]
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Depression [ Time Frame: After 4th chemotherapy cycle ] [ Designated as safety issue: No ]
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.

Secondary Outcome Measures:

Degree of acculturation [ Time Frame: After 4th chemotherapy cycle ] [ Designated as safety issue: No ]
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.

Enrollment:	442
Study Start Date:	December 2006
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Arm I- Usual psychological care Usual psychological care- no intervention
Experimental: Arm II -Self administered Stress Management Training Self-Administered Stress Management Training Plus Usual Psychosocial Care	Other: Self Administered Stress Management Training 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. Other Name: self-administered stress management training (SSMT)

Arms

Assigned Interventions

No Intervention: Arm I- Usual psychological care

Usual psychological care- no intervention

Experimental: Arm II -Self administered Stress Management Training

Self-Administered Stress Management Training Plus Usual Psychosocial Care

Other: Self Administered Stress Management Training

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.

Other Name: self-administered stress management training (SSMT)

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

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

Contacts and Locations

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

Show 51 Study Locations

Sponsors and Collaborators

University of South Florida

National Cancer Institute (NCI)

Investigators

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

More Information

Additional 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

No publications provided

Responsible Party:	University of South Florida
ClinicalTrials.gov Identifier:	NCT00377130 History of Changes
Other Study ID Numbers:	SCUSF 0501, SCUSF-0501, HLMCC-0501, 5U10CA081920-11
Study First Received:	September 13, 2006
Last Updated:	May 20, 2013
Health Authority:	United States: Federal Government United States: Data and Safety Monitoring Board

Keywords provided by University of South Florida:

psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on May 22, 2013