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Breast CancerPhase 2NCT01422551

Facilitating Positive Adaptation to Breast Cancer

A Phase 2 study testing Cognitive Behavioral Stress Management in people with Breast Cancer, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial adaptation and physiological adaptation in women being treated for stage I-III breast cancer. Read more about this study

Who is it for?
Ages 21 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Cognitive Behavioral Stress Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
Sep 1999to Aug 2007
Phase
Phase 2
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 21 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy

Who cannot join

  • prior cancer,
  • prior psychiatric treatment for a serious disorder (e.g., psychosis, suicidality),
  • lack of fluency in English and had begun adjuvant therapy at time of first assessment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Department of Psychology University of Miami

    Coral Gables, Florida, 33124

Other trials in United States

About this study

The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial adaptation and physiological adaptation in women being treated for stage I-III breast cancer.

Read the detailed description

The study tests the effects of a 10-wk group-based cognitive behavioral stress management (CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a single-day psycho-educational seminar (general information about stress and coping) in women who have recently had surgery for breast cancer but have not yet started adjuvant therapy. The study evaluates the effects of CBSM on psychosocial adaptation (includes measures of negative adaptation [distress and social disruption] and positive adaptation [benefit finding and positive affect]) at 6-month and 12-month follow-up. The study also evaluates the effects of CBSM on physiological adaptation (includes levels of PM serum cortisol and T-helper-type 1 (Th1) cytokine [interleukin-2, IL-2, and interferon-gamma, IFN-g, production after anti-CD3 stimulation of peripheral blood mononuclear cells (PBMC).

Conditions
Breast Cancer
Being tested
Cognitive Behavioral Stress Management, a psycho-educational control
Keywords
stress management intervention, breast cancer, quality of life, psychosocial adaptation
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Stress ManagementBehavioural

    10 weekly 2-hour sessions of group-based cognitive behavioral stress management

  • a psycho-educational controlBehavioural

    a single-day psycho-educational seminar

Study groups in NCT01422551
Study groupRoleWhat they receive
Cognitive Behavioral Stress ManagementExperimental10 weekly 2-hour sessions of group-based cognitive behavioral stress management
Receives: Behavioral: Cognitive Behavioral Stress Management
Psycho-educational ControlActive comparatora single day group-based psycho-educational seminar
Receives: Behavioral: a psycho-educational control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect)

    changes in a composite composed of negative affect measures plus a measure of social disruption plus a measure of benefit finding plus a measure of positive affect

    Measured: baseline and 6 and 12 month follow-up

Secondary outcomes (1)

  1. change from baseline to 12 months in physiological adaptation (decreased serum cortisol and increased Th1 cytokine production)

    decreased PM levels of serum cortisol and increased Th1 (interleukin-2, interferon-gamma) cytokine production following anti-CD3 stimulation of peripheral blood mononuclear cells (PBMCs)

    Measured: baseline and 6 and 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2011 (estimated)
  2. Study startSep 1999
  3. Primary completionAug 2007
  4. Study completionAug 2007

Resources

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 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01422551
Sponsor's protocol ID
19930536
Other IDs
R01CA064710
Status last verified
Aug 2011
First submitted
21 Aug 2011
Last updated
24 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Antoni MH, Wimberly SR, Lechner SC, Kazi A, Sifre T, Urcuyo KR, Phillips K, Smith RG, Petronis VM, Guellati S, Wells KA, Blomberg B, Carver CS. Reduction of cancer-specific thought intrusions and anxiety symptoms with a stress management intervention among women undergoing treatment for breast cancer. Am J Psychiatry. 2006 Oct;163(10):1791-7. doi: 10.1176/ajp.2006.163.10.1791.

    PubMed 17012691

  • Antoni MH, Lechner SC, Kazi A, Wimberly SR, Sifre T, Urcuyo KR, Phillips K, Gluck S, Carver CS. How stress management improves quality of life after treatment for breast cancer. J Consult Clin Psychol. 2006 Dec;74(6):1143-52. doi: 10.1037/0022-006X.74.6.1152.

    PubMed 17154743

  • Antoni MH, Lechner S, Diaz A, Vargas S, Holley H, Phillips K, McGregor B, Carver CS, Blomberg B. Cognitive behavioral stress management effects on psychosocial and physiological adaptation in women undergoing treatment for breast cancer. Brain Behav Immun. 2009 Jul;23(5):580-91. doi: 10.1016/j.bbi.2008.09.005. Epub 2008 Sep 20.

    PubMed 18835434

  • Phillips KM, Antoni MH, Lechner SC, Blomberg BB, Llabre MM, Avisar E, Gluck S, DerHagopian R, Carver CS. Stress management intervention reduces serum cortisol and increases relaxation during treatment for nonmetastatic breast cancer. Psychosom Med. 2008 Nov;70(9):1044-9. doi: 10.1097/PSY.0b013e318186fb27. Epub 2008 Oct 8.

    PubMed 18842742

  • Blomberg BB, Alvarez JP, Diaz A, Romero MG, Lechner SC, Carver CS, Holley H, Antoni MH. Psychosocial adaptation and cellular immunity in breast cancer patients in the weeks after surgery: An exploratory study. J Psychosom Res. 2009 Nov;67(5):369-76. doi: 10.1016/j.jpsychores.2009.05.016. Epub 2009 Sep 24.

    PubMed 19837199

  • St Fleur RG, Ream M, Krueger MJ, Crane T, Blomberg BB, Antoni MH. Cognitive behavioral stress management and physical activity in breast cancer survivors: A two-part growth model. Health Psychol. 2026 Aug;45(8):837-847. doi: 10.1037/hea0001584. Epub 2026 Mar 5.

    PubMed 41785110

  • Jutagir DR, Blomberg BB, Carver CS, Lechner SC, Timpano KR, Bouchard LC, Gudenkauf LM, Jacobs JM, Diaz A, Lutgendorf SK, Cole SW, Heller AS, Antoni MH. Social well-being is associated with less pro-inflammatory and pro-metastatic leukocyte gene expression in women after surgery for breast cancer. Breast Cancer Res Treat. 2017 Aug;165(1):169-180. doi: 10.1007/s10549-017-4316-3. Epub 2017 May 30.

    PubMed 28560656

  • Antoni MH, Bouchard LC, Jacobs JM, Lechner SC, Jutagir DR, Gudenkauf LM, Carver CS, Lutgendorf S, Cole SW, Lippman M, Blomberg BB. Stress management, leukocyte transcriptional changes and breast cancer recurrence in a randomized trial: An exploratory analysis. Psychoneuroendocrinology. 2016 Dec;74:269-277. doi: 10.1016/j.psyneuen.2016.09.012. Epub 2016 Sep 24.

    PubMed 27689900

  • Bouchard LC, Antoni MH, Blomberg BB, Stagl JM, Gudenkauf LM, Jutagir DR, Diaz A, Lechner S, Gluck S, Derhagopian RP, Carver CS. Postsurgical Depressive Symptoms and Proinflammatory Cytokine Elevations in Women Undergoing Primary Treatment for Breast Cancer. Psychosom Med. 2016 Jan;78(1):26-37. doi: 10.1097/PSY.0000000000000261.

    PubMed 26569533

  • Stagl JM, Bouchard LC, Lechner SC, Blomberg BB, Gudenkauf LM, Jutagir DR, Gluck S, Derhagopian RP, Carver CS, Antoni MH. Long-term psychological benefits of cognitive-behavioral stress management for women with breast cancer: 11-year follow-up of a randomized controlled trial. Cancer. 2015 Jun 1;121(11):1873-81. doi: 10.1002/cncr.29076. Epub 2015 Mar 23.

    PubMed 25809235

  • Vargas S, Antoni MH, Carver CS, Lechner SC, Wohlgemuth W, Llabre M, Blomberg BB, Gluck S, DerHagopian RP. Sleep quality and fatigue after a stress management intervention for women with early-stage breast cancer in southern Florida. Int J Behav Med. 2014 Dec;21(6):971-81. doi: 10.1007/s12529-013-9374-2.

    PubMed 24318654

  • Antoni MH, Lutgendorf SK, Blomberg B, Carver CS, Lechner S, Diaz A, Stagl J, Arevalo JM, Cole SW. Cognitive-behavioral stress management reverses anxiety-related leukocyte transcriptional dynamics. Biol Psychiatry. 2012 Feb 15;71(4):366-72. doi: 10.1016/j.biopsych.2011.10.007. Epub 2011 Nov 16.

    PubMed 22088795

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cognitive Behavioral Stress Management in people with Breast Cancer, run by University of Miami at 1 site in United States.

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 1 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 24 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect) (time frame: baseline and 6 and 12 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01422551, which also lists 12 linked publications.

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 24 Aug 2011.

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