Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer (BC-SEGT)

October 13, 2016 updated by: Tânia Brandão, Universidade do Porto

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

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-135
        • Recruiting
        • Tânia Brandão
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPCEUP/BreastCancerCare

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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