Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer

Study Overview
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Brief Summary
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To test the feasibility of supportive-expressive group intervention (SEGT) for women with primary breast cancer and to provide a preliminary test of its efficacy.

Detailed Description
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This study aims to compare the efficacy of a 16-sessions group intervention (Supportive-Expressive group therapy) versus control group (no intervention) in women with primary breast cancer. This study tries to evaluate the efficacy of SEGT on breast cancer patients' emotion regulation, social support, caregiving, and marital satisfaction, and its improvement on breast cancer patients' life quality. This study also intents to explore the moderating role of attachment on these associations.

Official Title
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Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention (SEGT) for Women With Breast Cancer

Conditions
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Breast Neoplasms, Breast Cancer

Intervention / Treatment
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* Other: Supportive-expressive group therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of primary breast cancer Exclusion Criteria: attendance at a cancer support group or individual psychotherapy diagnosis of recurrent breast cancer severe psychiatric disorder history of drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group - SEGT<br>16 weekly sessions, 90 min of Supportive-expressive group therapy | Other: Supportive-expressive group therapy<br>* The supportive-expressive group therapy (SEGT) is an intervention for women with BC that is designed to build bonds and to facilitate changes in emotional expression and regulation taking into account the role that emotions play in physiologic function, intimately related to the progression of the disease. It is based on seven main themes: building bonds, expressing feelings, detoxifying dying, reordering life priorities, improve support from and communication with family and friends, fortifying families, dealing with doctors, and control pain and anxiety. Although originally developed according to an existential perspective, recently the supportive-expressive group therapy has been used according to an attachment framework.<br>* Other names: SEGT;|
| No Intervention: Control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life across time | The World Health Organization Quality of Life - BREF | T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in emotion suppression across time | The Emotion Regulation Questionnaire | T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later | 
| Change in emotional self-efficacy across time | The Stanford Emotional Self-Efficacy Scale-Cancer | T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later | 
| Change in cognitive emotion across time | The Cognitive Emotion Regulation Questionnaire | T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later | 
| Change in social support across time | The Multidimensional Scale of Perceived Social Support | T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later | 
| Change in caregiving across time | The Caregiving Questionnaire | T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later | 
| Change in marital relationship across time | Relationship Assessment Scale | T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychological intervention, breast cancer, supportive-expressive group therapy, emotion regulation, social support, attachment, quality of life