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

Quality of Life Clinical Trial

— Oncovox  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161312
• Other study ID #: BabesBolyaiOncovox
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: February 2024
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Distress, Emotional
• Quality of Life

Intervention

Behavioral:
• iACT-BC: Oncovox
A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' attitudes towards internet interventions	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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