Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377130
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : January 31, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date  ICMJE September 13, 2006
First Posted Date  ICMJE September 15, 2006
Last Update Posted Date January 31, 2014
Study Start Date  ICMJE December 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
  • Quality of life [ Time Frame: After 4th chemotherapy cycle ]
    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 ]
    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 ]
    Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
Degree of acculturation [ Time Frame: After 4th chemotherapy cycle ]
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
Official Title  ICMJE Stress Management Therapy for Patients Undergoing Chemotherapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Psychological Stress
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE Other: Self Administered Stress Management
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)
Study Arms  ICMJE
  • No Intervention: Arm I- Usual psychological care
    Usual psychological care- no intervention
  • Experimental: Self administered Stress Management
    Self-Administered Stress Management Training Plus Usual Psychosocial Care
    Intervention: Other: Self Administered Stress Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2006)
442
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377130
Other Study ID Numbers  ICMJE SCUSF 0501
SCUSF-0501 ( Other Identifier: SunCoast CCOP Research Base )
HLMCC-0501 ( Other Identifier: H. Lee Moffitt Cancer Center Research Base )
5U10CA081920-11 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Teletia Taylor, PhD Howard University Cancer Center
Study Chair: Susan McMillan, PhD RN FAAN H. Lee Moffitt Cancer Center and Research Institute
PRS Account University of South Florida
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP