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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasm
• Intervention / Treatment: Behavioral: iACT-BC

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Cristina M Santos, MsC; Phone Number: +351917890798; Email: cristina.mendes.santos@liu.se
• Study Contact Backup: Name: Gerhard Andersson, PhD; Email: gerhard.andersson@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - iACT-BC experimental group	Behavioral: iACT-BC; A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors
Other: B - Waiting list control group	Behavioral: iACT-BC; A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Health Questionnaire (PHQ-9)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Fatigue	Brief Fatigue Inventory (BFI)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
Insomnia	Insomnia Severity Index (ISI)	Change from baseline to post-intervention (10 weeks after enrollment), Follow-ups at 3, 6 and 12 months
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: Escola Nacional de Saúde Pública - Universidade Nova de Lisboa

Publications and helpful links

General Publications

• Mendes-Santos C, Weiderpass E, Santana R, Andersson G. A guided internet-delivered individually-tailored ACT-influenced cognitive behavioural intervention to improve psychosocial outcomes in breast cancer survivors (iNNOVBC): Study protocol. Internet Interv. 2019 Feb 10;17:100236. doi: 10.1016/j.invent.2019.01.004. eCollection 2019 Sep.

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Breast Cancer; Randomized controlled trial; Acceptance and Commitment Therapy (ACT); Psychosocial intervention; Survivors; Internet intervention
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: INNOVBC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No