Clinical trial NCT02103387: Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
Official title: Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-04-03
Enrollment: 194
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: This is a randomized controlled trial comparing the effects of 5-wk group-based stress management interventions (cognitive behavioral therapy \[CBT\] or relaxation training \[RT\]) vs a time-matched 5-wk group-based health education (HE) condition on psychosocial adaptation (negative and positive mood, social disruption) and physiological adaptation (cortisol and immune function) in women with non-metastatic breast cancer who are undergoing primary treatment. Participants are recruited in the weeks after surgery and before the start of adjuvant chemotherapy or radiation, are assessed for baseline psychosocial and physiological adaptation indicators, and are then randomly allocated to either CBT, RT or HE. They are re-assessed for psychosocial and physiological adaptation at 6 and 12 month follow-up. Primary hypothesis is that women assigned to CBT or RT will show greater reductions in negative affect and social disruption, and greater increases in positive affect over time compared to women assigned to HE. Secondary hypothesis is that women assigned to CBT or RT will show greater decreases in cortisol and greater increases in immune functioning over time compared to those assigned to HE.

Eligibility criteria: 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

Primary outcomes:
measure: Negative affect as measured by the Affect Balance Scale- Negative Affect subscale
timeFrame: Changes in scores from baseline to 12-month follow-up
measure: Positive affect as measured by the Affect Balance Scale- Positive Affect subscale
timeFrame: Changes in scores from baseline to 12-month follow-up
measure: Social disruption as measure by the Sickness Impact Profile- Social Interaction subscale
timeFrame: Changes in scores from baseline to 12-month follow-up
Secondary outcomes:
measure: Physiological Adaptation
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Department of Psychology
state: Florida
Study officials:
affiliation: University of Miami
name: Michael H Antoni, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ream M, Saez-Clarke E, Taub C, Diaz A, Frasca D, Blomberg BB, Antoni MH. Brief Post-Surgical Stress Management Reduces Pro-Inflammatory Cytokines in Overweight and Obese Breast Cancer Patients Undergoing Primary Treatment. Front Biosci (Landmark Ed). 2022 May 7;27(5):148. doi: 10.31083/j.fbl2705148.
citation: Diaz A, Taub CJ, Lippman ME, Antoni MH, Blomberg BB. Effects of brief stress management interventions on distress and leukocyte nuclear factor kappa B expression during primary treatment for breast cancer: A randomized trial. Psychoneuroendocrinology. 2021 Apr;126:105163. doi: 10.1016/j.psyneuen.2021.105163. Epub 2021 Feb 4.