Stress Management Therapy in Patients Receiving Chemotherapy for Cancer

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT00377130

Collaborator

National Cancer Institute (NCI) (NIH)

442

Enrollment

Locations

Arms

Duration (Months)

8.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Psychological Stress Unspecified Adult Solid Tumor, Protocol Specific	Other: Self Administered Stress Management	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

442 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Stress Management Therapy for Patients Undergoing Chemotherapy

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: self-administered stress management training (SSMT)

Arm

Intervention/Treatment

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 Names:

self-administered stress management training (SSMT)

Outcome Measures

Primary Outcome Measures

Quality of life [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 [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 [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 Outcome Measures

Degree of acculturation [After 4th chemotherapy cycle]
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contra Costa Regional Medical Center	Martinez	California	United States	94553
2	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
3	Bay Area Tumor Institute	Oakland	California	United States	94609
4	Howard University Cancer Center	Washington	District of Columbia	United States	20060
5	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois	United States	60612-9985
6	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois	United States	60612
7	Savoy Medical Center	Mamou	Louisiana	United States	70554
8	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
9	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71101-4295
10	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
11	CCOP - Beaumont	Royal Oak	Michigan	United States	48073
12	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
13	William Beaumont Hospital - Troy Campus	Troy	Michigan	United States	48085
14	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
15	St. John's Regional Health Center	Springfield	Missouri	United States	65804-2263
16	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65804
17	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
18	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
19	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York	United States	10466-2604
20	Dickstein Cancer Treatment Center at White Plains Hospital Center	White Plains	New York	United States	10601
21	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina	United States	27534-9479
22	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina	United States	27534
23	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
24	High Point Regional Hospital	High Point	North Carolina	United States	27262
25	Iredell Memorial Hospital	Statesville	North Carolina	United States	28687-1828
26	Southeastern Medical Oncology Center - Wilson	Wilson	North Carolina	United States	27893
27	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
28	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
29	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota	United States	58122
30	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
31	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
32	CCOP - Columbus	Columbus	Ohio	United States	43215
33	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
34	Mount Carmel Hospital East	Columbus	Ohio	United States	43215
35	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
36	Mount Carmel St. Ann's Cancer Center	Columbus	Ohio	United States	43222
37	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
38	Grady Memorial Hospital	Delaware	Ohio	United States	43015
39	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750-1635
40	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055-2899
41	Springfield Regional Cancer Center	Springfield	Ohio	United States	45504
42	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
43	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
44	Scott and White Cancer Institute	Temple	Texas	United States	76508
45	Rainier Physicians - NWMS	Puyallup	Washington	United States	98372
46	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
47	Andres Grillasca Hospital	Ponce		Puerto Rico	00733-1324
48	Hato Rey Hematology/Oncology Group, PSC	San Juan		Puerto Rico	00917-5025
49	I. Gonzalez Martinez Oncologic Hospital	San Juan		Puerto Rico	00919-1811
50	Veterans Affairs Medical Center - San Juan	San Juan		Puerto Rico	00927-5800
51	San Juan City Hospital	San Juan		Puerto Rico	00936-7344

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of South Florida

ClinicalTrials.gov Identifier:

NCT00377130

Other Study ID Numbers:

SCUSF 0501
SCUSF-0501
HLMCC-0501
5U10CA081920-11

First Posted:

Sep 15, 2006

Last Update Posted:

Jan 31, 2014

Last Verified:

Sep 1, 2010

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

Study Results

No Results Posted as of Jan 31, 2014