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Breast CancerADAPTNCT03866655

Evaluating a Digital Tool for Supporting Breast Cancer Patients

A study testing OWise in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
OWise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteUnited Kingdom
Study dates
1 Oct 2019to 30 Dec 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Royal Marsden NHS Foundation Trust

    London, SW9 8LE

Other trials in United Kingdom

About this study

Official title: Evaluating a Digital Tool for Supporting Breast Cancer Patients: A Prospective Randomised Controlled Trial

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
Being tested
OWise
Keywords
Breast Cancer, Digital, eHealth, Supportive Care, Patient Activation, Resource Utilisation
Medical subject headings
Breast Neoplasms, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OWiseDevice

    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.

Study groups in NCT03866655
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Device: OWise
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

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

    The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire measures health status and includes the descriptive system and the EuroQol visual analogue scale (EQ VAS). The descriptive system has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of response resulting in a single digit number that expresses the level for that dimension (1-5): no problems, slight problems, moderate problems, severe problems and extreme problems. Combined, the digits for the 5 dimensions create a 5-digit number that describes the patient's health state. For each health state, a corresponding index value will be determined.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The worst health you can imagine' and 'The best health you can imagine' with numbers between 0 and 100. This score is a quantitative measure of health outcome that reflects the patient's own judgement.

    Measured: 3 months, 6 months and 1 year after diagnosis

  2. 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)

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core30 (EORTC-QLQ-C30 version 3) is a 30-item questionnaire measuring quality of life. It consists of five functional scales (physical, role, cognitive, emotional and social), a global quality of life scale, three symptom scales (fatigue, pain, nausea and vomiting), single items assessing common symptoms (dyspnea, loss of appetite, sleep disturbance, constipation and diarrhea) and a single item assessing perceived financial impact.

    After linear transformation, all scales and single item measures range in score from 0-100. A higher score on the functional scales and global quality of life scale indicates better function and HRQoL. A higher score on the symptom scales and items indicates higher symptom burden.

    Measured: 3 months, 6 months and 1 year after diagnosis

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

    The Hospital Anxiety and Distress Scale (HADS) questionnaire is a 14-item instrument measuring anxiety, depression and overall psychological distress, with seven items assessing anxiety and seven items assessing depression. Each item is scored from 0-3 and meaning a person can score between 0 and 21 for either anxiety or depression. The summed total score reflects the level of psychological distress. Higher total scores are indicative of more psychological distress.

    We will compare the mean change in each of the three scale scores in the intervention and control arm in simple and multiple linear regression models including potential covariates. Based on the continuous overall psychological distress score, patients are classified as 'distressed' when they have a score of ≥8, and 'not distressed' when they have a score <8.

    Measured: 3 months, 6 months and 1 year after diagnosis

  4. Resource Utilisation

    Number of primary, secondary and social care visits consumed by each patient. We will extract the total number of clinic or hospital visits to the general practitioner, secondary care, emergency departments, urgent care and social care. We will extract the average number of resources consumed by each patient and the average cost associated with each patient in total and stratified by commissioning group and secondary hospital.

    We will present the mean rate of resource utilisation in the two groups for the various types of resources (primary, secondary and social care) and for the total National Health Service (NHS) resources. The secondary analysis will compare the mean rate of total resource utilisation in the two groups in simple and multiple linear regression models including potential covariates.

    Measured: 1 year

  5. Health care costs

    Cost per patient according to clinical commissioning group. We will extract the average number of resources consumed by each patient and the average cost associated with each patient in total and stratified by commissioning group and secondary hospital.

    We will present the mean cost per patient in the two groups for the various types of resources (primary, secondary and social care) and for the total NHS resources. The secondary analysis will compare the mean cost per patient in the two groups in simple and multiple linear regression models including potential covariates.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start1 Oct 2019
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

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
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03866655
Sponsor's protocol ID
CCR4965
Acronym
ADAPT
Status last verified
Feb 2022
First submitted
19 Feb 2019
Last updated
21 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The patient reported outcomes will be available via the PROFILES Registry at the Royal Marsden NHS Foundation Trust.

Publications

  • 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.

    PubMed 41060446

  • 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.

    PubMed 39432189

  • 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.

    PubMed 31941539

Questions about this trial

What is this clinical trial studying?

A study testing OWise in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Feb 2022. 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 United Kingdom. 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?

Results are not available in the source record.

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?

Comparison of the change in patient activation (validated questionnaire: Patient Activation Measure (PAM-13) Survey) (time frame: 3 months after diagnosis (primary objective); 6 months and 1 year (secondary objective)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03866655, which also lists 3 linked publications.

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 21 Feb 2022.

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