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

Babes-Bolyai University

Status

Completed

Conditions

Cancer, Breast

Quality of Life

Distress, Emotional

Treatments

Behavioral: iACT-BC: Oncovox

Study type

Interventional

Funder types

Other

Identifiers

NCT05161312

BabesBolyaiOncovox

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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