Breast NeoplasmsBC-SEGTNCT02934815
Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer
A study testing Supportive-expressive group therapy in people with Breast Neoplasms and Breast Cancer, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- Supportive-expressive group therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of primary breast cancer
Who cannot join
- attendance at a cancer support group or individual psychotherapy
- diagnosis of recurrent breast cancer
- severe psychiatric disorder
- history of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Tânia Brandão
Porto, Porto District, 4200-135
Tânia Brandão, PhD Student, 914169443, taniabrandao@fpce.up.pt
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasms, Breast Cancer
- Being tested
- Supportive-expressive group therapy
- Keywords
- psychological intervention, breast cancer, supportive-expressive group therapy, emotion regulation, social support, attachment, quality of life
- Medical subject headings
- Breast Neoplasms, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive-expressive group therapyOther
Also called SEGT
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - SEGT | Experimental | 16 weekly sessions, 90 min of Supportive-expressive group therapy Receives: Other: Supportive-expressive group therapy |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life across time
The World Health Organization Quality of Life - BREF
Measured: 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
The Emotion Regulation Questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Change in caregiving across time
The Caregiving Questionnaire
Measured: 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
Measured: T0 - before the intervention; T1 - 2 months later; T2 - 4 months later; T3 - 10 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Tânia Brandão, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934815
- Sponsor's protocol ID
- FPCEUP/BreastCancerCare
- Acronym
- BC-SEGT
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention (SEGT) for Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT02934815
- Acronym / sponsor ID
- BC-SEGT / FPCEUP/BreastCancerCare
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- psychological intervention, breast cancer, supportive-expressive group therapy, emotion regulation, social support, attachment, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- 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
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - SEGT | Experimental | Other: Supportive-expressive group therapy16 weekly sessions, 90 min of Supportive-expressive group therapy |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of primary breast cancer
Key exclusion criteria (4 listed)
- attendance at a cancer support group or individual psychotherapy
- diagnosis of recurrent breast cancer
- severe psychiatric disorder
- history of drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive-expressive group therapyAlso: SEGTThe 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 | Intervention group - SEGT |
Primary outcome
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
6 secondary outcomes
Change in emotion suppression across time
Time frame: 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
Change in cognitive emotion across time
Time frame: 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
Change in caregiving across time
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive-expressive group therapy in people with Breast Neoplasms and Breast Cancer, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.