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Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

Primary Purpose

Cancer, Psychological Stress, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Self Administered Stress Management
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contra Costa Regional Medical Center
  • CCOP - Bay Area Tumor Institute
  • Bay Area Tumor Institute
  • Howard University Cancer Center
  • John H. Stroger, Jr. Hospital of Cook County
  • MBCCOP - JHS Hospital of Cook County
  • Savoy Medical Center
  • Louisiana State University Health Sciences Center - Monroe
  • Veterans Affairs Medical Center - Shreveport
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • CCOP - Beaumont
  • William Beaumont Hospital - Royal Oak Campus
  • William Beaumont Hospital - Troy Campus
  • MeritCare Bemidji
  • St. John's Regional Health Center
  • CCOP - Cancer Research for the Ozarks
  • Hulston Cancer Center at Cox Medical Center South
  • Newark Beth Israel Medical Center
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • Dickstein Cancer Treatment Center at White Plains Hospital Center
  • CCOP - Southeast Cancer Control Consortium
  • Southeastern Medical Oncology Center - Goldsboro
  • Pardee Memorial Hospital
  • High Point Regional Hospital
  • Iredell Memorial Hospital
  • Southeastern Medical Oncology Center - Wilson
  • Forsyth Regional Cancer Center at Forsyth Medical Center
  • CCOP - MeritCare Hospital
  • Roger Maris Cancer Center at MeritCare Hospital
  • Adena Regional Medical Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Medical Center Cancer Care
  • Mount Carmel Hospital East
  • Mount Carmel Health - West Hospital
  • Mount Carmel St. Ann's Cancer Center
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Springfield Regional Cancer Center
  • Genesis - Good Samaritan Hospital
  • CCOP - Scott and White Hospital
  • Scott and White Cancer Institute
  • Rainier Physicians - NWMS
  • CCOP - Northwest
  • Andres Grillasca Hospital
  • Hato Rey Hematology/Oncology Group, PSC
  • I. Gonzalez Martinez Oncologic Hospital
  • Veterans Affairs Medical Center - San Juan
  • San Juan City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm I- Usual psychological care

Self administered Stress Management

Arm Description

Usual psychological care- no intervention

Self-Administered Stress Management Training Plus Usual Psychosocial Care

Outcomes

Primary Outcome Measures

Quality of life
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Anxiety
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Depression
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
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.

Full Information

First Posted
September 13, 2006
Last Updated
January 30, 2014
Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00377130
Brief Title
Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
Official Title
Stress Management Therapy for Patients Undergoing Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Psychological Stress, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I- Usual psychological care
Arm Type
No Intervention
Arm Description
Usual psychological care- no intervention
Arm Title
Self administered Stress Management
Arm Type
Experimental
Arm Description
Self-Administered Stress Management Training Plus Usual Psychosocial Care
Intervention Type
Other
Intervention Name(s)
Self Administered Stress Management
Other Intervention Name(s)
self-administered stress management training (SSMT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life
Description
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Time Frame
After 4th chemotherapy cycle
Title
Anxiety
Description
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Time Frame
after 4th chemotherapy cycle
Title
Depression
Description
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Time Frame
After 4th chemotherapy cycle
Secondary Outcome Measure Information:
Title
Degree of acculturation
Description
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Time Frame
After 4th chemotherapy cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teletia Taylor, PhD
Organizational Affiliation
Howard University Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susan McMillan, PhD RN FAAN
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Howard University Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-9985
Country
United States
Facility Name
MBCCOP - JHS Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Savoy Medical Center
City
Mamou
State/Province
Louisiana
ZIP/Postal Code
70554
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Monroe
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71210
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101-4295
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
CCOP - Beaumont
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital - Troy Campus
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
MeritCare Bemidji
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804-2263
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466-2604
Country
United States
Facility Name
Dickstein Cancer Treatment Center at White Plains Hospital Center
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Southeastern Medical Oncology Center - Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
High Point Regional Hospital
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Iredell Memorial Hospital
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28687-1828
Country
United States
Facility Name
Southeastern Medical Oncology Center - Wilson
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
Forsyth Regional Cancer Center at Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Roger Maris Cancer Center at MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Hospital East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Mount Carmel St. Ann's Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750-1635
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055-2899
Country
United States
Facility Name
Springfield Regional Cancer Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Scott and White Cancer Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Rainier Physicians - NWMS
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States
Facility Name
Andres Grillasca Hospital
City
Ponce
ZIP/Postal Code
00733-1324
Country
Puerto Rico
Facility Name
Hato Rey Hematology/Oncology Group, PSC
City
San Juan
ZIP/Postal Code
00917-5025
Country
Puerto Rico
Facility Name
I. Gonzalez Martinez Oncologic Hospital
City
San Juan
ZIP/Postal Code
00919-1811
Country
Puerto Rico
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
San Juan City Hospital
City
San Juan
ZIP/Postal Code
00936-7344
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

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