Clinical trial NCT02934815: Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer
Official title: Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention (SEGT) for Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Breast Cancer
Keywords: psychological intervention
breast cancer
supportive-expressive group therapy
emotion regulation
social support
attachment
quality of life
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Centro Hospitalar De São João, E.P.E.
name: Mama Help - Support Centre for Breast Cancer Patients
First posted: 2016-10-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in quality of life across time
timeFrame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Secondary outcomes:
measure: Change in emotion suppression across time
timeFrame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
measure: Change in emotional self-efficacy across time
timeFrame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
measure: Change in cognitive emotion across time
timeFrame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
measure: Change in social support across time
timeFrame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
measure: Change in caregiving across time
timeFrame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
measure: Change in marital relationship across time
timeFrame: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Other outcomes:
measure: Change in group climate across time
timeFrame: T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Locations:
city: Porto
country: Portugal
facility: Tânia Brandão
Study officials:
References: