NCT02934815

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 12, 2016

Last Update Submit

October 13, 2016

Conditions

Breast NeoplasmsBreast Cancer

Keywords

psychological interventionbreast cancersupportive-expressive group therapyemotion regulationsocial supportattachmentquality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in emotion suppression across time

    T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

  • Change in emotional self-efficacy across time

    T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

  • Change in cognitive emotion across time

    T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

  • Change in social support across time

    T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

  • Change in caregiving across time

    T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

  • +1 more secondary outcomes

Other Outcomes (1)

  • Change in group climate across time

    T1 - 2 months later; T2 - 4 months later; T3 - 10 months later

Study Arms (2)

Intervention group - SEGT

EXPERIMENTAL

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

Other: Supportive-expressive group therapy

Control group

NO INTERVENTION

No intervention

Interventions

Supportive-expressive group therapyOTHER

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.

Also known as: SEGT
Intervention group - SEGT

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of primary breast cancer

You may not qualify if:

  • attendance at a cancer support group or individual psychotherapy
  • diagnosis of recurrent breast cancer
  • severe psychiatric disorder
  • history of drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tânia Brandão

Porto, Porto District, 4200-135, Portugal

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsEmotional Regulation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSelf-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Student

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 17, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 17, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)