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

NCT05161312 | Completed DMC

• 1 other identifier: BabesBolyaiOncovox
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• Distress - Distress Thermometer (DT)

  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)

  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)

  Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months

Other Outcomes (1)

• Participants' attitudes towards internet interventions

  Change from baseline to post-intervention (10 weeks after enrollment), Follow ups at 1, 2 and 12 months

Study Arms (2)

iACT-BC: Oncovox experimental

EXPERIMENTAL

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

Behavioral: iACT-BC: Oncovox

Wait list control group

NO INTERVENTION

Wait list, treatment as usual

Interventions

iACT-BC: Oncovox BEHAVIORAL

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

iACT-BC: Oncovox experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only female BC diagnosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, 400015, Romania

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Silvia M Nicolescu, Ms

  Babes-Bolyai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd. Candidate

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: November 15, 2021
• Primary Completion: February 25, 2022
• Study Completion: May 25, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)