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

Breast Cancer Clinical Trial

— BC-SEGT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934815
• Other study ID #: FPCEUP/BreastCancerCare
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2016
• Last updated: October 13, 2016
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Data Protection Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Portugal	Tânia Brandão	Porto

Sponsors (5)

Lead Sponsor	Collaborator
Universidade do Porto	Centro Hospitalar De São João, E.P.E., Centro Hospitalar de Vila Nova de Gaia/Espinho, Fundação para a Ciência e a Tecnologia, Mama Help - Support Centre for Breast Cancer Patients

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in group climate across time	The Group Climate Questionnaire	T1 - 2 months later; T2 - 4 months later; T3 - 10 months later	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Change in caregiving across time	The Caregiving Questionnaire	T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later	Yes
Secondary	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	Yes