An interventional study of iACT-BC: Oncovox in Cancer, Breast, Quality of Life and Distress, Emotional, sponsored by Babes-Bolyai University. Completed at 1 site in Romania. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Supportive care
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.
An exploratory moderator analysis will be employed to the assess the significance of Time x Group as well as Time x Group x Surgery type interactions for all outcome and process variables. A mediation analysis to assess the effect of psychological flexibility on the outcomes will also be applied.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 150 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Babes-Bolyai University is the lead sponsor of 48 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years.
Behavioral: iACT-BC: Oncovox
Wait list, treatment as usual
A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years
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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
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.
Time frame: 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
Time frame: 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.
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
Participants' attitudes towards internet interventions
Attitudes towards internet interventions survey (ATTIS) Attitudes towards internet interventions survey (ATTIS)
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Babes-Bolyai University