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Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

NCT ID: NCT02103387

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-02

Study Completion Date

2014-02-25

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Behavioral Training

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

Group Type EXPERIMENTAL

Cognitive Behavioral Training

Intervention Type BEHAVIORAL

Cognitive Behavioral Training \[CBT\] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)

Relaxation Training

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

Group Type EXPERIMENTAL

Relaxation Training

Intervention Type BEHAVIORAL

Relaxation Training \[RT\] (muscle relaxation, deep breathing, guided imagery, meditation)

Health Education Control

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

Group Type ACTIVE_COMPARATOR

Health Education Control

Intervention Type BEHAVIORAL

Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)

Interventions

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Cognitive Behavioral Training

Cognitive Behavioral Training \[CBT\] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)

Intervention Type BEHAVIORAL

Relaxation Training

Relaxation Training \[RT\] (muscle relaxation, deep breathing, guided imagery, meditation)

Intervention Type 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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Michael H. Antoni

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael H Antoni, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Department of Psychology

Coral Gables, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35638415 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33611132 (View on PubMed)

Other Identifiers

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2R01CA064710

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20060496

Identifier Type: -

Identifier Source: org_study_id