A Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients - a Randomised Clinical Trial

Study Overview
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Brief Summary
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Background: Online interventions can be a fast, cost-efficient, and convenient medium for providing breast cancer patients (BCP) with access to evidence-based interventions that address their emotional needs. As true as that may be, online interventions are still a novel research area that struggles in implementation. Objectives: This study aims to determine the acceptability, feasibility, and efficacy of Oncovox, an iACT-BC, a guided internet delivered ACT intervention designed to improve psychosocial outcomes in BCP diagnosed within the last two years when compared to treatment as usual. The primary outcomes in this study are health related quality of life, behavioural activation, symptom interference and reward observation. The secondary outcomes are psychosocial distress, anxiety and depression and psychological flexibility. Methods: A two-arm, parallel, open label, waiting list randomised controlled trial will investigate the effectiveness, feasibility, and acceptability of Oncovox. Expected results: It is anticipated that Oncovox will show to be effective, feasible and acceptable programme in improving health related quality of life, behavioural activation, symptom interference, reward observation, psychological distress, anxiety, depression, and psychological flexibility in BCP diagnosed in the last two years, 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 September 2022.

Official Title
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Oncovox - An Acceptance and Commitment Therapy Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients: a Randomised Clinical Trial

Conditions
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Cancer, Breast, Quality of Life, Distress, Emotional

Intervention / Treatment
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* Behavioral: iACT-BC: Oncovox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent. Age ≥ 18 years Ability to read and write in Romanian History of histologically or cytologically confirmed breast cancer An interval of < 24 months from histologically or cytologically confirmed breast cancer Ongoing curative cancer treatment 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iACT-BC: Oncovox experimental<br>A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years. | Behavioral: iACT-BC: Oncovox<br>* A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years<br>|
| No Intervention: Wait list control group<br>Wait list, treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life - Functional Assessment of Cancer Therapy - Breast (FACT-B) | A a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). | Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months | 
| Behavioral activation - Behavioral activation scale (BAS) | Assessing the appetitive-motivational system that is activated by reward consumption and conditioned signals of reward or non-punishment, triggering approach behaviour. | Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months | 
| Symptom interference - MD Anderson Symptom Inventory (MDASI) | Severity of symptoms experienced by patients with cancer and the interference with daily living caused by these symptoms. | Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months | 
| Reward observation - Environmental reward observation scale (EROS) | Reports on quantity and availability of reinforcement received by patient from environment | Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress - Distress Thermometer (DT) | a multifactorial unpleasant experience of a psychological (i.e., cognitive, behavioral, emotional), social, spiritual and/or physical nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment. | Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months | 
| Anxiety & depression - Hospital Anxiety and Depression Scale (HADS) | Measures anxiety and depression in a general medical population of patients | Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months | 
| Psychological flexibility - Acceptance and Action Questionnaire for Cancer (AAQ-II-C) | Scale used to assess psychological inflexibility. | Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy (ACT), Online intervention, Psychosocial intervention, Breast cancer, Quality of life, Randomized controlled trial