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Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00377130
First received: September 13, 2006
Last updated: January 30, 2014
Last verified: September 2010
  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
Psychological Stress
Unspecified Adult Solid Tumor, Protocol Specific
Other: Self Administered Stress Management

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:


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
Study Completion Date: May 2010
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: Self administered Stress Management
Self-Administered Stress Management Training Plus Usual Psychosocial Care
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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 51 Study Locations
Sponsors and Collaborators
University of South Florida
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:
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: January 30, 2014
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

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 20, 2014