Five Sessions Intervention to Facilitate Adaptation to Breast Cancer
2 other identifiers
interventional
194
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jan 2007
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2014
CompletedFirst Submitted
Initial submission to the registry
March 27, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedNovember 10, 2020
November 1, 2020
7.2 years
March 27, 2014
November 6, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Physiological Adaptation
12 month follow-up
Study Arms (3)
Cognitive Behavioral Training
EXPERIMENTALCognitive Behavioral Training 5 weekly 1.5-hour sessions of group-based cognitive behavioral training
Relaxation Training
EXPERIMENTALRelaxation Training 5 weekly 1.5-hour sessions of group-based relaxation training
Health Education Control
ACTIVE COMPARATORHealth Education Control 5 weekly 1.5 sessions of group-based health education training
Interventions
Cognitive Behavioral Training \[CBT\] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)
Relaxation Training \[RT\] (muscle relaxation, deep breathing, guided imagery, meditation)
Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)
Eligibility Criteria
You may qualify if:
- women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Department of Psychology
Coral Gables, Florida, 33124, United States
Related Publications (2)
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.
PMID: 35638415DERIVEDDiaz 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.
PMID: 33611132DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael H Antoni, Ph.D.
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 3, 2014
Study Start
January 2, 2007
Primary Completion
February 25, 2014
Study Completion
February 25, 2014
Last Updated
November 10, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share