Brief group interventions with breast cancer survivors

ISRCTN	ISRCTN75243042
DOI	https://doi.org/10.1186/ISRCTN75243042
Secondary identifying numbers	N/A

Submission date: 03/10/2013
Registration date: 19/12/2013
Last edited: 19/12/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Anabela Pereira
Scientific

Campus Universitário of Santiago
Department of Education
University of Aveiro
Aveiro
3810-193
Portugal

Email	anabelapereira@ua.pt

Study information

Study design	Multi-site quasi-experimental trial with equivalent control group
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	The effect of brief group interventions on psychosocial adjustment of breast cancer survivors
Study objectives	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(s)	Portuguese Cancer League, 2008
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2009
Completion date	31/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	62
Key inclusion criteria	1. Over 18 years old 2. Received breast cancer diagnosis and treatment 3. Does not present currently signals of disease
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	31/03/2013

Locations

Countries of recruitment

Portugal

Study participating centre

Campus Universitário of Santiago

Aveiro
3810-193
Portugal

Sponsor information

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

Av. D. Carlos I, 126
Lisbon
1249-074
Portugal

Email	bolsas@fct.pt
"ROR"	https://ror.org/00snfqn58

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Abstract results		01/03/2011	No	No
Abstract results		01/06/2012	No	No
Other publications	Torres, A., Pereira, A. & Monteiro, S. (). [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.	27/11/2012	Yes	No