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Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Training
Relaxation Training
Health Education Control
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Training

Relaxation Training

Health Education Control

Arm Description

Cognitive Behavioral Training 5 weekly 1.5-hour sessions of group-based cognitive behavioral training

Relaxation Training 5 weekly 1.5-hour sessions of group-based relaxation training

Health Education Control 5 weekly 1.5 sessions of group-based health education training

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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)

Full Information

First Posted
March 27, 2014
Last Updated
November 6, 2020
Sponsor
University of Miami
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02103387
Brief Title
Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
Official Title
Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2007 (Actual)
Primary Completion Date
February 25, 2014 (Actual)
Study Completion Date
February 25, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Training
Arm Type
Experimental
Arm Description
Cognitive Behavioral Training 5 weekly 1.5-hour sessions of group-based cognitive behavioral training
Arm Title
Relaxation Training
Arm Type
Experimental
Arm Description
Relaxation Training 5 weekly 1.5-hour sessions of group-based relaxation training
Arm Title
Health Education Control
Arm Type
Active Comparator
Arm Description
Health Education Control 5 weekly 1.5 sessions of group-based health education training
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Training
Intervention Description
Cognitive Behavioral Training [CBT] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Description
Relaxation Training [RT] (muscle relaxation, deep breathing, guided imagery, meditation)
Intervention Type
Behavioral
Intervention Name(s)
Health Education Control
Intervention Description
Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)
Primary Outcome Measure Information:
Title
Negative affect as measured by the Affect Balance Scale- Negative Affect subscale
Description
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.
Time Frame
Changes in scores from baseline to 12-month follow-up
Title
Positive affect as measured by the Affect Balance Scale- Positive Affect subscale
Description
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.
Time Frame
Changes in scores from baseline to 12-month follow-up
Title
Social disruption as measure by the Sickness Impact Profile- Social Interaction subscale
Description
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.
Time Frame
Changes in scores from baseline to 12-month follow-up
Secondary Outcome Measure Information:
Title
Physiological Adaptation
Description
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)
Time Frame
12 month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Antoni, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33124
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35638415
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.
Results Reference
derived
PubMed Identifier
33611132
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.
Results Reference
derived

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Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

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