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A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC): Study protocol
Linköping University, Department of Culture and Communication, Culture and Aesthetics. Linköping University, Faculty of Science & Engineering. Universidade Nova de Lisboa, Lisboa, Portugal.
Institute of Population-Based Cancer Research, Oslo, Norway; University of Tromsø, The Arctic University of Norway, Tromsø, Norway; Karolinska Institutet, Stockholm, Sweden; University of Helsinki, Helsinki, Finland.
Universidade Nova de Lisboa, Lisboa, Portugal.
Linköping University, Department of Behavioural Sciences and Learning, Psychology. Linköping University, Faculty of Arts and Sciences. Region Östergötland, Anaesthetics, Operations and Specialty Surgery Center, Department of Otorhinolaryngology. Karolinska Institutet, Stockholm, Sweden. (Internet, health and clinical psychology research group)ORCID iD: 0000-0003-4753-6745
2019 (English)In: Internet Interventions, ISSN 2214-7829, Internet interventions, ISSN 2214-7829, Vol. 17, article id 100236Article in journal (Refereed) Published
Abstract [en]

Background: Internet-delivered interventions can provide remarkable opportunities in addressing breast cancer survivors' unmet support care needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on improving survivors' psychosocial needs using internet-based tools is scarce and its practical implementation is limited.

Objectives: To study the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, a 10 weeks guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural (CBT) intervention developed to improve mild to moderate anxiety and depression in Breast cancer survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC).

Methods: A two-arm, parallel, open label, multicentre, waiting list randomized controlled trial will be conducted to investigate the efficacy and cost-effectiveness of INNOVBC. The primary outcomes in this research will be anxiety and depression. Secondary outcomes will include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL).

Ethical approval: This study has been reviewed and approved by Comissão Nacional de Proteção de Dados; Instituto Português de Oncologia do Porto Francisco Gentil; Unidade Local de Saúde de Matosinhos, EPE; Centro Hospitalar de São João and Ordem dos Psicólogos ethical committees.

Expected results: It is anticipated that iNNOVBC will show to be an efficacious and cost-effective program in improving the outcomes of interest in this study, as opposed to a WLC under TAU. The results of this research will be published in accordance with CONSORT-EHEALTH guidelines.

Conclusions: This study will inform on the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, in improving psychosocial outcomes in breast cancer survivors when compared to TAU in a WLC. Its conclusions will contribute to understand the idiosyncrasies of designing and implementing internet-delivered interventions in breast cancer survivors.Trial Registration code: INNOVBC (NCT03275727).

Place, publisher, year, edition, pages
Elsevier, 2019. Vol. 17, article id 100236
Keywords [en]
Acceptance and Commitment Therapy (ACT), Breast cancer survivors, Internet psychosocial intervention, Portugal, EU, Randomized controlled trial protocol
National Category
Applied Psychology
Identifiers
URN: urn:nbn:se:liu:diva-160297DOI: 10.1016/j.invent.2019.01.004ISI: 000485180400001PubMedID: 30949435Scopus ID: 2-s2.0-85063066338OAI: oai:DiVA.org:liu-160297DiVA, id: diva2:1351992
Note

Funding agencies: Erasmus + Programme of the European Union

Available from: 2019-09-17 Created: 2019-09-17 Last updated: 2019-09-30Bibliographically approved

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Andersson, Gerhard

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