Condition category
Cancer
Date applied
03/10/2013
Date assigned
19/12/2013
Last edited
19/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Scientific research has found that cancer survivors face worries about the future, depression, post-traumatic symptoms and lower quality of life. Most studies provide support using cognitive-behavioural therapy (CBT) strategies. However, this is not studied in detail for breast cancer survivors especially in Portugal. The current study aims to find out how acceptable and effective the two brief group intervention programs are for breast cancer survivors.

Who can participate?
Women aged 18 years or older who were diagnosed and received treatment for breast cancer in the past and do not have the disease at present.

What does the study involve?
Participants were randomly allocated to one of three groups: a control group, a psychoeducational intervention group or a cognitive-behavior therapy group. Participants were followed up at two different occasions.

What are the possible benefits and risks of participating?
Participants in the intervention groups may have improved quality of life. Participants in the control group will not receive any direct benefit from participation. We do not anticipate any risks, side effects or discomforts as a result of participation.

Where is the study run from?
The study is run from the Portuguese Cancer League and from Hospital of Braga, both in Portugal.

When is study starting and how long is it expected to run for?
The study started in April 2009 and ran until March 2013.

Who is funding the study?
Portuguese Foundation of Science and Technology (Fundação ciência e tecnologia [FCT]) (Portugal).

Who is the main contact?
Dr Natália Amaral

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anabela Pereira

ORCID ID

Contact details

Campus Universitário of Santiago
Department of Education
University of Aveiro
Aveiro
3810-193
Portugal
anabelapereira@ua.pt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of brief group interventions on psychosocial adjustment of breast cancer survivors

Acronym

Study hypothesis

1. Participants treated with brief group interventions will present better psychosocial adjustment and quality of life than the control group.
2. Participants treated with a psychoeducational intervention will present different outcomes to those who participated in cognitive-behaviour group therapy.
3. Participants treated with brief group interventions will present effects until 6 months and there is interference of psychosocial variables on the outcomes of the interventions.

Ethics approval

Portuguese Cancer League, 2008

Study design

Multi-site quasi-experimental trial with equivalent control group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Breast cancer survivors

Intervention

Subjects of the Reach to Recovery Movement of the Portuguese Cancer League were invited to participate in the study, as well as cancer survivors followed up in Senology Unit of the Hospital of Braga. Pre-existent groups were randomly allocated to one of three groups:
1. Control group
2. Psychoeducational intervention
3. Cognitive-behavioral therapy
Psychoeducational intervention and cognitive-behavioral therapy are group interventions, which are weekly structured sessions of 2 hours during 8 weeks.

The Portuguese Cancer League of the centre of Portugal has groups in extensions (the main is in the city of Coimbra, but there are also extensions in another cities: Viseu, Castelo Branco, Guarda, Leiria, Covilhã and Aveiro); these are pre-existent groups that were randomly allocated to the study conditions. The Hospital of Braga also had a pre-existent group, a sample available to the study, who was also allocated to a study condition.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Acceptability and feasibility will be measured:
1. Participant uptake of the intervention
2. Intervention session attendance
3. Rates of participant drop-out

Measured at pre-test, baseline, post-test: final intervention, 3 months follow-up and 6 months follow-up

Secondary outcome measures

1. Cancer Coping Questionnaire (CCQ)
2. Courtauld Emotional Control Scale (CEC)
3. Hospital Anxiety and Depression Scale (HADS)
4. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire with the Supplementary Questionnaire Breast Cancer Module (EORTC QLQ - C30 and BR -23)
5. Self-Concept Clinical Inventory (ICAC)
6. Life Orientation Test - Revised (LOT-R)
7. Patient Health Questionnaire (PHQ-9)
8. Profile of Mood States (POMS)
9. Personal Growth subscale of the Scale of Psychological Well-Being (EBEP)
10. Sub-scale of Spirituality
11. Inventory of State - Trait anxiety (STAI)

Measured at baseline, after 8 weeks, 3 months and 6 months

Overall trial start date

01/04/2009

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 18 years old
2. Received breast cancer diagnosis and treatment
3. Does not present currently signals of disease

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

62

Participant exclusion criteria

1. Younger than 18 years old
2. Inability to participate in groups
3. Conflicts with other members of group
4. History of other psychiatric disorders prior to illness
5. Suicidal ideation
6. Dependence on psychoactive substances (such drugs and alcohol)
7. Organic brain disorders

Recruitment start date

01/04/2009

Recruitment end date

31/03/2013

Locations

Countries of recruitment

Portugal

Trial participating centre

Campus Universitário of Santiago
Aveiro
3810-193
Portugal

Sponsor information

Organisation

Portuguese Foundation of Science and Technology (Fundação ciência e tecnologia) (FCT) (Portugal)

Sponsor details

Av. D. Carlos I
126
Lisbon
1249-074
Portugal
bolsas@fct.pt

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Portuguese Foundation of Science and Technology (Fundação ciência e tecnologia [FCT]) (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Torres, A., Pereira, A. & Monteiro, S. (2011). Efficacy of cognitive behavior group therapy with Portuguese breast cancer survivors. [Abstract] European Psychiatry, 26 (supl. 1):1690. (ISSN: 0924-9338)
2. Torres, A., Pereira, A., Monteiro, S. & Araújo, F. (2011). The effectiveness of psyhosocial groups in Portuguese breast cancer survivors: a pilot study [Abstract]. Psychooncology, 20 (supl.2): 84-85. Doi:10-1002/pon.2076 (ISSN:1057-9249)
3. Torres, A., Pereira, A. & Monteiro, S. (2012). Preliminary assessment of aplicability and effectiveness of group intervention with Portuguese breast cancer survivors. [Abstract] European Psychiatry, 27(supl.1): 1. (ISSN: 0924-9338)
4. Torres, A., Pereira, A. & Monteiro, S. (2012). [Cognitive-behaviour group therapy for breast cancer survivors: description of a program and preliminar evaluation of efficacy] Terapia de grupo cognitivo-comportamental para sobreviventes de cancro da mama: descrição de um programa e avaliação preliminar da sua eficácia. Psychology, Community and Health, 1(3):300-312. http://dx.doi.org/10.5964/pch.v1i3.55
5. Torres, A., Pereira, A., Monteiro, S. (2012). [Applicability and efficacy of the group intervention in the cancer disease; a study with breast cancer survivors] Aplicabilidade e eficácia da intervenção de grupo na doença crónica: estudo com sobreviventes de cancro da mama. [Abstract] Psicologia, Saúde e Doenças, 12(S1): 105-106.

Publication citations

Additional files

Editorial Notes