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.