NCT02103387

Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

Completed NA Last updated 10 November 2020

What this trial tests

NA trial testing Cognitive Behavioral Training in Breast Cancer in 194 participants. Completed in 25 February 2014.

Timeline

2 January 2007

Primary endpoint
25 February 2014

25 February 2014

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	194
Start date	2 January 2007
Primary completion	25 February 2014
Estimated completion	25 February 2014
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Behavioral Training
• Relaxation Training
• Health Education Control

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of Miami

Who can join

Adults 21 to 75, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral training or relaxation training) vs. a time-matched 5-wk health education condition on psychosocial adaptation and physiological adaptation in women being treated for breast cancer. Participants assigned to either of the stress management conditions will show improved psychosocial adaptation and physiological adaptation compared to those assigned to the health education condition.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Brief cognitive-behavioral and relaxation training interventions for breast cancer: A randomized controlled trial.
   Gudenkauf LM, Antoni MH, Stagl JM, Lechner SC, et al · · 2015 · cited 76× · PMID 25939017 · DOI 10.1037/ccp0000020
2. The effects of a randomized trial of brief forms of stress management on RAGE-associated S100A8/A9 in patients with breast cancer undergoing primary treatment.
   Taub CJ, Lippman ME, Hudson BI, Blomberg BB, et al · · 2019 · cited 26× · PMID 30633331 · DOI 10.1002/cncr.31965
3. Effects of brief stress management interventions on distress and leukocyte nuclear factor kappa B expression during primary treatment for breast cancer: A randomized trial.
   Diaz A, Taub CJ, Lippman ME, Antoni MH, et al · · 2021 · cited 19× · PMID 33611132 · DOI 10.1016/j.psyneuen.2021.105163
4. Brief relaxation training is associated with long-term endocrine therapy adherence among women with breast cancer: post hoc analysis of a randomized controlled trial.
   Ream ME, Walsh EA, Jacobs JM, Taub C, et al · · 2021 · cited 15× · PMID 34410568 · DOI 10.1007/s10549-021-06361-x
5. Relationships Between Serum Cortisol, RAGE-Associated s100A8/A9 Levels, and Self-Reported Cancer-Related Distress in Women With Nonmetastatic Breast Cancer.
   Taub CJ, Diaz A, Blomberg BB, Jutagir DR, et al · · 2022 · cited 7× · PMID 35980780 · DOI 10.1097/psy.0000000000001109
6. Brief Post-Surgical Stress Management Reduces Pro-Inflammatory Cytokines in Overweight and Obese Breast Cancer Patients Undergoing Primary Treatment.
   Ream M, Saez-Clarke E, Taub C, Diaz A, et al · · 2022 · cited 5× · PMID 35638415 · DOI 10.31083/j.fbl2705148
7. Does the Broaden-and-Build Theory Explain Reduction in Social Disruption After a Brief Relaxation Intervention for Women With Breast Cancer Undergoing Treatment?
   Fisher HM, Taub CJ, Lechner SC, Heller AS, et al · · 2022 · cited 3× · PMID 35987554 · DOI 10.1016/j.beth.2022.04.002
8. Brief Post-Surgical Stress Management Intervention Effects on Positive Psychological Well-Being and Self-Efficacy in Women Being Treated With Adjuvant Endocrine Therapy for Hormone-Receptor Positive Breast Cancer.
   Ream M, Taub CJ, Amonoo HL, Walsh EA, et al · · 2025 · cited 2× · PMID 40846861 · DOI 10.1002/pon.70267