A Guided Internet-delivered Individually-tailored ACT-influenced CBT Intervention to Improve Psychosocial Outcomes in Breast Cancer

Breast Neoplasm Clinical Trial

— INNOVBC  

Official title:

Self-care Programs in Oncology: a Guided Internet-delivered Individually-tailored Acceptance and Commitment Therapy (ACT)-Influenced Cognitive Behavioural Intervention to Improve Psychosocial Outcomes in Breast Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03275727
• Other study ID #: INNOVBC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: September 1, 2017
• Last updated: September 7, 2017
• Start date: February 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2017
• Source: Linkoeping University
• Contact: Cristina M Santos, MsC
• Phone: +351917890798
• Email: cristina.mendes.santos[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in addressing breast cancer (BC) survivors' unmet 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 this field and aiming at improving survivors´ psychosocial needs is scarce and its practical implementation is limited.

Objectives: This study aims at studying BC patients´ and healthcare providers' attitudes towards IDI; exploring BC patients´ unmet support needs and; determining the acceptability, feasibility, efficacy and cost-effectiveness of iACT-BC, a guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention designed to improve psychosocial outcomes in BC survivors when compared to treatment as usual. The primary outcomes in this research are anxiety and depression. Secondary outcomes include psychological flexibility, fatigue, insomnia, Sexual dysfunction (SD) and Health Related Quality of Life.

Methods: A multimethod research design will be applied and two consecutive studies will be performed. Study 1 will explore participants´ attitudes towards IDI as well as, BC patients' psychosocial unmet needs by adopting an exploratory cross-sectional study design. Study 2 will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm, parallel, open label, multicentre, waiting list randomized controlled trial.

Expected Results: It is anticipated that iACT-BC will show to be an effective and cost-effective program in improving anxiety, depression, psychological flexibility, fatigue, insomnia, SD and HRQoL in BC survivors, as opposing to a waiting list control under treatment as usual. The results of this research will be published in accordance with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in February 2020.

Description:

Background: Breast Cancer (BC) ranks as the most frequent and lethal cancer among women, in Portugal. However, advances in cancer detection and treatment contributed to a steady and significant increase in survival over the past years, and 5-year age-standardized relative survival is currently estimated to be 83,4%. This increase translates into a high and growing number of BC survivors, with a considerable proportion of these patients experiencing sequelae of treatment and late effects that can occur immediately to several years after primary treatment ends. Anxiety, depression, fear of recurrence, existential related issues, fatigue, pain, physical and cognitive impairment, tailored information needs, and sexual dysfunction have been reported as the most common unmet support care needs experienced by these women. The answer to these unmet support care needs relies, in part, on delivering comprehensive, highly coordinated, patient-centred care. However, operationalizing such care may prove difficult in a context of competing priorities and constrained health and social care budgets. In this context, connected health, particularly internet-delivered interventions, can provide remarkable opportunities in overcoming the aforementioned constraints, as presenting an effective and innovative healthcare delivery model capable of improving care coordination and providing access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on this field and aiming at improving survivors´ psychosocial needs is scarce and its practical implementation is limited.

Objectives: The objectives of this investigation are: studying BC patients´ and healthcare providers' attitudes towards internet-delivered interventions; exploring breast cancer patients´ unmet support care needs and; determining the acceptability, feasibility, effectiveness and cost-effectiveness of iACT-BC, a guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural intervention designed to improve psychosocial outcomes in BC survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC). The primary outcomes in this research are anxiety and depression. Secondary outcomes include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL).

Hypotheses: We hypothesize that participants in the intervention group will have improved anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL, when compared to a WLC.

Methods: A multimethod research design will be applied and two consecutive studies will be performed: Study 1 - Population characterization study and Study 2 - Efficacy and cost-effectiveness study. Study 1 will explore participants´ attitudes towards internet-delivered interventions as well as, BC patients' psychosocial unmet support needs by adopting an exploratory cross-sectional study design. Study 2 will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm, parallel, open label, multicentre, pragmatic, waiting list randomized controlled trial. A Pilot study, mirroring the conditions applied in Study 2 should be performed in order to evaluate the feasibility and acceptability of iACT-BC. Results from this Pilot study should be appraised and inform execution of Study 2

Ethical approval: This study will soon be submitted to evaluation by CNPD and local ethic committees. Authorization to run the study is expected to be received until January 2018.

Expected Results: It is anticipated that iACT-BC will show to be an effective and cost-effective program in improving psychosocial outcomes such as anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL in BC survivors, as opposing to a WLC under TAU. The results of this research will be published in accordance with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in February 2020.

Keywords: Breast Cancer; Survivors; Internet intervention; Psychosocial intervention; Acceptance and Commitment Therapy (ACT); Randomized controlled trial protocol.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed written informed consent.

• Age = 18 years;

• Ability to read and write in Portuguese.

• History of histologically or cytologically confirmed breast cancer with no evidence of metastatic disease.

• An interval = 6 month from primary adjuvant treatment completion (surgery, chemotherapy and/or radiotherapy), except for hormonal therapy.

• Clinically significant symptoms of at least one of the following conditions: anxiety, depression, fatigue, insomnia and/or sexual dysfunction.

• Ongoing regular psychoactive medication only accepted if dosage has been stable during the last 3 months.

• Daily access to the Internet by computer and/or smartphone.

• Ability to use a computer and/or smartphone and the internet.

• No participation on any other interventional study or clinical trial.

Exclusion Criteria:

• Age = 18 years;

• Inability to co-operate and give informed consent.

• Breast cancer not histologically or cytologically confirmed.

• History of other malignancy within the last 5 years.

• Metastasized breast cancer.

• Current severe, uncontrolled systemic disease or mental disorder.

• Absence of clinically significant symptoms.

• Parallel ongoing psychological treatment.

• Ongoing regular psychoactive medication if dosage has been changed during the last 3 months.

• No access to the internet.

• Inability to use a computer and/or smartphone and the internet.

• Parallel ongoing participation in other interventional study or clinical trial.

• Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Behavioral:
• iACT-BC
A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Escola Nacional de Saúde Pública - Universidade Nova de Lisboa

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' attitudes towards internet interventions	Attitudes towards internet interventions survey (ATTIS)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Other	Breast cancer patients' unmet support needs	Supportive Care Needs Survey Questionnaire (SCNS-SF34)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Other	Intervention cost-effectiveness	Questionnaire on Medical consumption and Productivity losses associated with Psychiatric Illness (TIC-P)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Other	Intervention cost-utility	EuroQol EQ-5D-5L	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Primary	Depression	Patient Health Questionnaire (PHQ-9)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Primary	Anxiety	Generalized Anxiety Disorder Scale (GAD-7)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Secondary	Psychological flexibility	Cancer Acceptance and Action Questionnaire (Cancer AAQ)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Secondary	Fatigue	Brief Fatigue Inventory (BFI)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Secondary	Insomnia	Insomnia Severity Index (ISI)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Secondary	Sexual dysfunction	Female Sexual Function Index (FSFI)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Secondary	Health related quality of life - generic measure	EORTC QLQC30	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Secondary	Health related quality of life - breast cancer specific measure	EORTC QLQBR23	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months

External Links

•   Study website