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Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

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University of Miami

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Relaxation Training
Behavioral: Health Education Control
Behavioral: Cognitive Behavioral Training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02103387
20060496
2R01CA064710 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

194 patients

Sex

Female

Ages

21 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

194 participants in 3 patient groups

Cognitive Behavioral Training
Experimental group
Description:
Cognitive Behavioral Training 5 weekly 1.5-hour sessions of group-based cognitive behavioral training
Treatment:
Behavioral: Cognitive Behavioral Training
Relaxation Training
Experimental group
Description:
Relaxation Training 5 weekly 1.5-hour sessions of group-based relaxation training
Treatment:
Behavioral: Relaxation Training
Health Education Control
Active Comparator group
Description:
Health Education Control 5 weekly 1.5 sessions of group-based health education training
Treatment:
Behavioral: Health Education Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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