A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC): Study protocol

Cristina Mendes-Santos, Elisabete Weiderpass, Rui Santana, Gerhard Andersson

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Abstract

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).

Original languageEnglish
Article number100236
JournalInternet Interventions
Volume17
DOIs
Publication statusPublished - 1 Sep 2019

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Acceptance and Commitment Therapy
Internet
Waiting Lists
Survivors
Breast Neoplasms
Cost-Benefit Analysis
Control Groups
Anxiety
Depression
Costs and Cost Analysis
Reproductive Health
Sleep Initiation and Maintenance Disorders
Feasibility Studies
Research
Fatigue
Therapeutics
Survival Rate
Randomized Controlled Trials
Quality of Life
Outcome Assessment (Health Care)

Keywords

  • Acceptance and Commitment Therapy (ACT)
  • Breast cancer survivors
  • Internet psychosocial intervention
  • Portugal, EU
  • Randomized controlled trial protocol

Cite this

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title = "A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC): Study protocol",
abstract = "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 Comiss{\~a}o Nacional de Prote{\cc}{\~a}o de Dados; Instituto Portugu{\^e}s de Oncologia do Porto Francisco Gentil; Unidade Local de Sa{\'u}de de Matosinhos, EPE; Centro Hospitalar de S{\~a}o Jo{\~a}o and Ordem dos Psic{\'o}logos 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).",
keywords = "Acceptance and Commitment Therapy (ACT), Breast cancer survivors, Internet psychosocial intervention, Portugal, EU, Randomized controlled trial protocol",
author = "Cristina Mendes-Santos and Elisabete Weiderpass and Rui Santana and Gerhard Andersson",
year = "2019",
month = "9",
day = "1",
doi = "10.1016/j.invent.2019.01.004",
language = "English",
volume = "17",
journal = "Internet Interventions",
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T1 - A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC)

T2 - Study protocol

AU - Mendes-Santos, Cristina

AU - Weiderpass, Elisabete

AU - Santana, Rui

AU - Andersson, Gerhard

PY - 2019/9/1

Y1 - 2019/9/1

N2 - 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).

AB - 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).

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KW - Breast cancer survivors

KW - Internet psychosocial intervention

KW - Portugal, EU

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