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

Primary Purpose

Breast Neoplasms, Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Supportive-expressive group therapy
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring psychological intervention, breast cancer, supportive-expressive group therapy, emotion regulation, social support, attachment, quality of life

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tânia BrandãoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group - SEGT

Control group

Arm Description

16 weekly sessions, 90 min of Supportive-expressive group therapy

No intervention

Outcomes

Primary Outcome Measures

Change in quality of life across time
The World Health Organization Quality of Life - BREF

Secondary Outcome Measures

Change in emotion suppression across time
The Emotion Regulation Questionnaire
Change in emotional self-efficacy across time
The Stanford Emotional Self-Efficacy Scale-Cancer
Change in cognitive emotion across time
The Cognitive Emotion Regulation Questionnaire
Change in social support across time
The Multidimensional Scale of Perceived Social Support
Change in caregiving across time
The Caregiving Questionnaire
Change in marital relationship across time
Relationship Assessment Scale

Full Information

First Posted
October 12, 2016
Last Updated
October 13, 2016
Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Centro Hospitalar de Vila Nova de Gaia/Espinho, Centro Hospitalar De São João, E.P.E., Mama Help - Support Centre for Breast Cancer Patients
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1. Study Identification

Unique Protocol Identification Number
NCT02934815
Brief Title
Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer
Acronym
BC-SEGT
Official Title
Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention (SEGT) for Women With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
Collaborators
Fundação para a Ciência e a Tecnologia, Centro Hospitalar de Vila Nova de Gaia/Espinho, Centro Hospitalar De São João, E.P.E., Mama Help - Support Centre for Breast Cancer Patients

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Breast Cancer
Keywords
psychological intervention, breast cancer, supportive-expressive group therapy, emotion regulation, social support, attachment, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group - SEGT
Arm Type
Experimental
Arm Description
16 weekly sessions, 90 min of Supportive-expressive group therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Supportive-expressive group therapy
Other Intervention Name(s)
SEGT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality of life across time
Description
The World Health Organization Quality of Life - BREF
Time Frame
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Secondary Outcome Measure Information:
Title
Change in emotion suppression across time
Description
The Emotion Regulation Questionnaire
Time Frame
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Title
Change in emotional self-efficacy across time
Description
The Stanford Emotional Self-Efficacy Scale-Cancer
Time Frame
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Title
Change in cognitive emotion across time
Description
The Cognitive Emotion Regulation Questionnaire
Time Frame
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Title
Change in social support across time
Description
The Multidimensional Scale of Perceived Social Support
Time Frame
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Title
Change in caregiving across time
Description
The Caregiving Questionnaire
Time Frame
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Title
Change in marital relationship across time
Description
Relationship Assessment Scale
Time Frame
T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Other Pre-specified Outcome Measures:
Title
Change in group climate across time
Description
The Group Climate Questionnaire
Time Frame
T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tânia Brandão
City
Porto
ZIP/Postal Code
4200-135
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tânia Brandão, PhD Student
Phone
914169443
Email
taniabrandao@fpce.up.pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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