- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934815
Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer (BC-SEGT)
Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention (SEGT) for Women With Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Porto, Portugal, 4200-135
- Recruiting
- Tânia Brandão
-
Contact:
- Tânia Brandão, PhD Student
- Phone Number: 914169443
- Email: taniabrandao@fpce.up.pt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group
No intervention
|
|
EXPERIMENTAL: Intervention group - SEGT
16 weekly sessions, 90 min of Supportive-expressive group therapy
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life across time
Time Frame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
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
Time Frame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
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
Time Frame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
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
Time Frame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
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
Time Frame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
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
Time Frame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
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
Time Frame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
Relationship Assessment Scale
|
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in group climate across time
Time Frame: T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
The Group Climate Questionnaire
|
T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPCEUP/BreastCancerCare
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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