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Completed

NCT Number: NCT00377130

Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

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.

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Key information

Conditions

Cancer Behavior Behavioral Symptoms Neoplasms Psychological Stress Stress, Psychological Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andres Grillasca Hospital, Ponce, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self Administered Stress Management

Other

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 names: self-administered stress management training (SSMT)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Stress Management Therapy for Patients Undergoing Chemotherapy

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2006
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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