Clinical trial · Interventional
Evaluating a Digital Tool for Supporting Breast Cancer Patients
Evaluating a Digital Tool for Supporting Breast Cancer Patients: A Prospective Randomised Controlled Trial
NCT03866655CI-TRIAL-00056641ADAPTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OWise | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- interventionNames
- Device: OWise
- type
- NO_INTERVENTION
- label
- Control
Primary outcomes (1)
- measure
- Comparison of the change in patient activation (validated questionnaire: Patient Activation Measure (PAM-13) Survey)
- timeFrame
- 3 months after diagnosis (primary objective); 6 months and 1 year (secondary objective)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * female * adult (age 18 years or over) * newly diagnosed * early breast cancer * first primary cancer diagnosis * under treatment at one of the participating sites. Exclusion Criteria: * 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
References
Publications (3)
- DERIVEDVrancken 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
- DERIVEDVrancken 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
- DERIVEDLidington 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