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

February 26, 2024 updated by: Silvia Nicolescu, Babes-Bolyai University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Romania
      • Cluj-Napoca, Romania, 400015
        • Babeș-Bolyai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life - Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
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)
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
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)
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
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)
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
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)
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
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)
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
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)
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
Scale used to assess psychological inflexibility.
Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' attitudes towards internet interventions
Time Frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months

Attitudes towards internet interventions survey (ATTIS)

Attitudes towards internet interventions survey (ATTIS)
Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Babes-Bolyai University

Investigators

  • Principal Investigator: Silvia M Nicolescu, Ms, Babeș-Bolyai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

February 25, 2022

Study Completion (Actual)

May 25, 2022

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BabesBolyaiOncovox

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on iACT-BC: Oncovox

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe