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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Breast Neoplasms
• Intervention / Treatment: Other: Supportive-expressive group therapy

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • 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: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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

Number of Arms

2

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	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.; Other Names: SEGT

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in group climate across time	The Group Climate Questionnaire	T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): January 1, 2017
• Study Completion (ANTICIPATED): January 1, 2017

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (ESTIMATE): October 17, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; attachment; social support; psychological intervention; emotion regulation; supportive-expressive group therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FPCEUP/BreastCancerCare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO