Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Cognitive Behavioral Training; Behavioral: Relaxation Training; Behavioral: Health Education Control

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33124
      • Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Training; Cognitive Behavioral Training 5 weekly 1.5-hour sessions of group-based cognitive behavioral training	Behavioral: Cognitive Behavioral Training; Cognitive Behavioral Training [CBT] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)
Experimental: Relaxation Training; Relaxation Training 5 weekly 1.5-hour sessions of group-based relaxation training	Behavioral: Relaxation Training; Relaxation Training [RT] (muscle relaxation, deep breathing, guided imagery, meditation)
Active Comparator: Health Education Control; Health Education Control 5 weekly 1.5 sessions of group-based health education training	Behavioral: Health Education Control; Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative affect as measured by the Affect Balance Scale- Negative Affect subscale	Change from baseline to 12-month follow-up in the Affect Balance Scale- Negative Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Negative Affect subscale (i.e., depression, hostility, guilt, anxiety) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more negative affect. Possible scores range from 0-5.	Changes in scores from baseline to 12-month follow-up
Positive affect as measured by the Affect Balance Scale- Positive Affect subscale	Change from baseline to 12-month follow-up in the Affect Balance Scale- Positive Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Positive Affect subscale (i.e., affection, contentment, vigor, joy) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more positive affect. Possible scores range from 0-5.	Changes in scores from baseline to 12-month follow-up
Social disruption as measure by the Sickness Impact Profile- Social Interaction subscale	Change from baseline to 12-month follow-up in the Sickness Impact Profile- Social Interaction subscale, a 16-item subscale measuring the level of disruption in social activities. Respondents are asked statements regarding social disengagement as they specifically apply to their breast cancer (e.g., "I am doing fewer social activities with groups of people") over the past few weeks, and are asked to respond either No (0) or Yes (1), this applies to me. Scores are summed, with higher scores indicating greater social disruption. Possible scores range from 0-16.	Changes in scores from baseline to 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Adaptation	Change from baseline to 12 month follow-up in physiological adaptation (decreased serum cortisol, and increased Th1 cytokine production and lower Th2 cytokine production following anti-CD3 stimulation of peripheral blood mononuclear cells (PBMCs)	12 month follow-up

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michael H Antoni, Ph.D., University of Miami

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2007
• Primary Completion (Actual): February 25, 2014
• Study Completion (Actual): February 25, 2014

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20060496; 2R01CA064710 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No