NCT01422551

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Sep 1999

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
Last Updated

August 24, 2011

Status Verified

August 1, 2011

Enrollment Period

7.9 years

First QC Date

August 21, 2011

Last Update Submit

August 22, 2011

Conditions

Breast Cancer

Keywords

stress management interventionbreast cancerquality of lifepsychosocial adaptation

Outcome Measures

Primary Outcomes (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

    baseline and 6 and 12 month follow-up

Secondary Outcomes (1)

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

    baseline and 6 and 12 months follow-up

Study Arms (2)

Cognitive Behavioral Stress Management

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Stress Management

Psycho-educational Control

ACTIVE COMPARATOR

a single day group-based psycho-educational seminar

Behavioral: a psycho-educational control

Interventions

Cognitive Behavioral Stress ManagementBEHAVIORAL

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

Cognitive Behavioral Stress Management
a psycho-educational controlBEHAVIORAL

a single-day psycho-educational seminar

Psycho-educational Control

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology University of Miami

Coral Gables, Florida, 33124, United States

Location

Related Publications (11)

  • 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.

    PMID: 17012691RESULT

  • 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.

    PMID: 17154743RESULT

  • 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.

    PMID: 18835434RESULT

  • 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.

    PMID: 18842742RESULT

  • 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.

    PMID: 19837199RESULT

  • 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.

    PMID: 28560656DERIVED

  • 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.

    PMID: 27689900DERIVED

  • 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.

    PMID: 26569533DERIVED

  • 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.

    PMID: 25809235DERIVED

  • 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.

    PMID: 24318654DERIVED

  • 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.

    PMID: 22088795DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Antoni, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 21, 2011

First Posted

August 24, 2011

Study Start

September 1, 1999

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

August 24, 2011

Record last verified: 2011-08

Locations

US(1)