Evaluating a Digital Tool for Supporting Breast Cancer Patients

NCT03866655 | Unknown

• 1 other identifier: CCR4965
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomised controlled trial that aims to understand the impact of the OWise breast cancer digital tool in newly diagnosed breast cancer patients. Half the patients will receive the digital tool and half the patients will receive standard information. The study will look at the impact of the digital tool on patient activation, health related quality of life (HRQoL), health status, psychological distress, NHS resource utilisation and health care costs.

Conditions

Breast Cancer

Keywords

Breast Cancer; Digital; eHealth; Supportive Care; Patient Activation; Resource Utilisation

Outcome Measures

Primary Outcomes (1)

• Comparison of the change in patient activation (validated questionnaire: Patient Activation Measure (PAM-13) Survey)

  The Patient Activation Measure (PAM-13) is a 13-item questionnaire measuring confidence in self management and knowledge of health condition. Each item has four possible responses from (1) strongly disagree to (4) strongly agree, with an additional 'not applicable' option. The measure views activation as a developmental process of four different levels, with the lowest scores corresponding to 'not believing activation important' and the highest scores corresponding to 'taking action.' The total score is calculated by dividing the raw score by the number of items answered (excluding items where 'not applicable' was selected) and multiplying by 13. This score is transformed using calibration tables to a scale with a theoretical range of 1-100, with a higher PAM score indicating higher patient activation.

  3 months after diagnosis (primary objective); 6 months and 1 year (secondary objective)

Secondary Outcomes (5)

• Comparison of the change in health status (validated questionnaire: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Survey)

  3 months, 6 months and 1 year after diagnosis

• Comparison of the change in health related quality of life (validated questionnaire: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core30 (EORTC-QLQ-C30 version 3) Survey)

  3 months, 6 months and 1 year after diagnosis

• Comparison of the change in psychological distress (validated questionnaire: HADS)

  3 months, 6 months and 1 year after diagnosis

• Resource Utilisation

  1 year

• Health care costs

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Device: OWise

Control

NO INTERVENTION

Interventions

OWise DEVICE

OWise Breast Cancer is a supportive care digital tool for breast cancer patients. The tool can be accessed as a mobile phone application or as a website. The tool has various tools for self-managing and self-monitoring treatment and symptoms such as an appointment calendar, a symptom-tracker, a modifiable question list and a recording device for consultations.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• adult (age 18 years or over)
• newly diagnosed
• early breast cancer
• first primary cancer diagnosis
• under treatment at one of the participating sites.

You may not qualify if:

• have started anti-cancer treatment
• private patients
• unable to read or write in English
• significant cognitive impairment
• poor mental health
• do not have access to the internet
• confirmed metastatic disease

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Innovate UK: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW9 8LE, United Kingdom

Location

Related Publications (3)

• Vrancken Peeters NJMC, Georgopoulou S, Kulakowski R, Hainsworth E, Lidington E, McGrath SE, Noble J, Azarang L, Husson O, Cruickshank S. Effect of a digital tool on breast cancer specific health-related quality of life and psychological distress: secondary results from the ADAPT study. Support Care Cancer. 2025 Oct 8;33(11):916. doi: 10.1007/s00520-025-09968-8.

  PMID: 41060446 DERIVED

• Vrancken Peeters NJMC, Husson O, Kulakowski R, Hainsworth E, Lidington E, McGrath SE, Noble J, Azarang L, Cruickshank S, Georgopoulou S. Evaluating a digital tool for supporting people affected by breast cancer: a prospective randomized controlled trial-the ADAPT study. Support Care Cancer. 2024 Oct 21;32(11):740. doi: 10.1007/s00520-024-08923-3.

  PMID: 39432189 DERIVED

• Lidington E, McGrath SE, Noble J, Stanway S, Lucas A, Mohammed K, van der Graaf W, Husson O. Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT). Trials. 2020 Jan 15;21(1):86. doi: 10.1186/s13063-019-3971-6.

  PMID: 31941539 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Olga Husson, PhD

  Institute of Cancer Research, United Kingdom

  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: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 7, 2019
• Study Start: October 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available one year after study closure.
• Access Criteria: The registry is accessible based on approval of specific research questions from the PROFILES Review and Management Group.

Locations

GB (1)