CancerNCT00377130
Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
A study testing Self Administered Stress Management in people with Cancer and Psychological Stress, run by University of South Florida at 51 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Psychological Stress, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Self Administered Stress Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Dec 2006to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States46 sites
MeritCare Bemidji
Bemidji, Minnesota, 56601
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-9985
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, 60612
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998
CCOP - Columbus
Columbus, Ohio, 43215
Grant Medical Center Cancer Care
Columbus, Ohio, 43215
Mount Carmel Hospital East
Columbus, Ohio, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222
Mount Carmel St. Ann's Cancer Center
Columbus, Ohio, 43222
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228
Grady Memorial Hospital
Delaware, Ohio, 43015
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, 58122
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, 27534
Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
High Point Regional Hospital
High Point, North Carolina, 27262
Savoy Medical Center
Mamou, Louisiana, 70554
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750-1635
Contra Costa Regional Medical Center
Martinez, California, 94553
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, 71210
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055-2899
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Bay Area Tumor Institute
Oakland, California, 94609
Rainier Physicians - NWMS
Puyallup, Washington, 98372
CCOP - Beaumont
Royal Oak, Michigan, 48073
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71101-4295
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932
St. John's Regional Health Center
Springfield, Missouri, 65804-2263
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
Springfield Regional Cancer Center
Springfield, Ohio, 45504
Iredell Memorial Hospital
Statesville, North Carolina, 28687-1828
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Scott and White Hospital
Temple, Texas, 76508
Scott and White Cancer Institute
Temple, Texas, 76508
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466-2604
William Beaumont Hospital - Troy Campus
Troy, Michigan, 48085
Howard University Cancer Center
Washington D.C., District of Columbia, 20060
Dickstein Cancer Treatment Center at White Plains Hospital Center
White Plains, New York, 10601
Southeastern Medical Oncology Center - Wilson
Wilson, North Carolina, 27893
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701
Puerto Rico5 sites
Andres Grillasca Hospital
Ponce, 00733-1324
Hato Rey Hematology/Oncology Group, PSC
San Juan, 00917-5025
I. Gonzalez Martinez Oncologic Hospital
San Juan, 00919-1811
Veterans Affairs Medical Center - San Juan
San Juan, 00927-5800
San Juan City Hospital
San Juan, 00936-7344
About this study
Official title: Stress Management Therapy for Patients Undergoing Chemotherapy
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.
Read the 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.
- Being tested
- Self Administered Stress Management
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Neoplasms, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Administered Stress ManagementOther
Also called self-administered stress management training (SSMT)
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm I- Usual psychological care | No intervention | Usual psychological care- no intervention |
| Self administered Stress Management | Experimental | Self-Administered Stress Management Training Plus Usual Psychosocial Care Receives: Other: Self Administered Stress Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Measured: After 4th chemotherapy cycle
Anxiety
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Measured: after 4th chemotherapy cycle
Depression
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Measured: After 4th chemotherapy cycle
Secondary outcomes (1)
Degree of acculturation
Assessed at baseline (before first chemotherapy cycle) and just before the start of the second, third and fourth chemotherapy cycles.
Measured: After 4th chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startDec 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Teletia Taylor, PhD, Study chair, Howard University Cancer CenterSusan McMillan, PhD RN FAAN, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377130
- Sponsor's protocol ID
- SCUSF 0501
- Other IDs
- SCUSF-0501, HLMCC-0501, 5U10CA081920-11
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2006
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management Therapy for Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT00377130
- Acronym / sponsor ID
- SCUSF 0501
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I- Usual psychological care | No intervention | –Usual psychological care- no intervention |
| Self administered Stress Management | Experimental | Other: Self Administered Stress ManagementSelf-Administered Stress Management Training Plus Usual Psychosocial Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self Administered Stress ManagementAlso: self-administered stress management training (SSMT)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 | Self administered Stress Management |
Primary outcome
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.
1 secondary outcome
Degree of acculturation
Time frame: After 4th chemotherapy cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teletia Taylor, PhD study chair
Howard University Cancer Center
Susan McMillan, PhD RN FAAN study chair
H. Lee Moffitt Cancer Center and Research Institute
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Administered Stress Management in people with Cancer and Psychological Stress, run by University of South Florida at 51 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: After 4th chemotherapy cycle). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.