Clinical trial · Interventional
Facilitating Positive Adaptation to Breast Cancer
NCT01422551CI-TRIAL-00005395completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| a psycho-educational control | Behavioral | — | UNRESOLVED |
| Cognitive Behavioral Stress Management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive Behavioral Stress Management
- description
- 10 weekly 2-hour sessions of group-based cognitive behavioral stress management
- interventionNames
- Behavioral: Cognitive Behavioral Stress Management
- type
- ACTIVE_COMPARATOR
- label
- Psycho-educational Control
- description
- a single day group-based psycho-educational seminar
- interventionNames
- Behavioral: a psycho-educational control
Primary outcomes (1)
- measure
- change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: -women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy Exclusion Criteria: * 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
References
Publications (12)
- RESULTAntoni 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 17012691
- RESULTAntoni 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 17154743
- RESULTAntoni 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 18835434
- RESULTPhillips 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 18842742
- RESULTBlomberg 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 19837199
- DERIVEDSt 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.