Cancer, BreastOncovoxNCT05161312
A Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients - a Randomised Clinical Trial
A study testing iACT-BC: Oncovox in people with Cancer, Breast and Quality of Life, run by Babes-Bolyai University at 1 site in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cancer, Breast, Quality of Life, Distress, Emotional
- What is being tested?
- iACT-BC: Oncovox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- 15 Nov 2021to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Cancer, Breast, Quality of Life, Distress, Emotional
- Being tested
- iACT-BC: Oncovox
- Keywords
- Acceptance and Commitment Therapy (ACT), Online intervention, Psychosocial intervention, Breast cancer, Quality of life, Randomized controlled trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iACT-BC: OncovoxBehavioural
A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years
| Study group | Role | What they receive |
|---|---|---|
| iACT-BC: Oncovox experimental | Experimental | A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years. Receives: Behavioral: iACT-BC: Oncovox |
| Wait list control group | No intervention | Wait list, treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Nov 2021
- Primary completion25 Feb 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Nicolescu, Babes-Bolyai University
- Investigators
- Silvia M Nicolescu, Ms, Principal investigator, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161312
- Sponsor's protocol ID
- BabesBolyaiOncovox
- Acronym
- Oncovox
- Status last verified
- Feb 2024
- First submitted
- 6 Dec 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncovox - An Acceptance and Commitment Therapy Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05161312
- Acronym / sponsor ID
- Oncovox / BabesBolyaiOncovox
- Conditions
- Cancer, Breast, Quality of Life, Distress, Emotional
- Keywords
- Acceptance and Commitment Therapy (ACT), Online intervention, Psychosocial intervention, Breast cancer, Quality of life, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iACT-BC: Oncovox experimental | Experimental | Behavioral: iACT-BC: OncovoxA guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years. |
| Wait list control group | No intervention | –Wait list, treatment as usual |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iACT-BC: OncovoxA guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years | Behavioural | iACT-BC: Oncovox experimental |
Primary outcome
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).
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.
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.
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
3 secondary outcomes
Distress - Distress Thermometer (DT)
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)
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)
Time frame: Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia M Nicolescu, Ms principal investigator
Babes-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iACT-BC: Oncovox in people with Cancer, Breast and Quality of Life, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.