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Completed

NCT Number: NCT05161312

A 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.

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Key information

Conditions

Cancer, Breast Breast Diseases Breast Neoplasms Distress, Emotional Neoplasms Neoplasms by Site Quality of Life Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, 400015, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iACT-BC: Oncovox

Behavioral

A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

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

Acronym: Oncovox

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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