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Randomised controlled trial of Vinehealth® digital health cancer solution

Multi-centre randomised controlled trial of Vinehealth® digital health cancer solution for cancer patients commencing chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44293246
Enrollment
180
Registered
2022-06-15
Start date
2022-06-17
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal, breast and lung cancer patients commencing adjuvant systemic treatment Cancer Malignant neoplasm of breast, Malignant neoplasm of bronchus and lung

Interventions

180 colorectal, breast and lung cancer patients commencing adjuvant systemic treatment (chemotherapy+/-targeted therapies) will be enrolled into a prospective, multi-centre two-arm parallel-group RCT

Sponsors

University of Surrey
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with breast, colorectal and lung cancer who have just had surgery for their primary cancer and are about to commence adjuvant chemotherapy as part of their treatment will be approached in oncology clinics to see if they would like to participate: 1. Adults (age >18 years) commencing adjuvant cytotoxic chemotherapy at participating site for the minimum planned duration of 12 weeks 2. Breast, colorectal or lung cancer diagnosis 3. Primary disease completely excised R0 with no evidence of macroscopic residual or metastatic disease 4. Smartphone access that conforms to the following specifications: 4.1. Apple devices running iOS 9.2 (or later) or devices running Android 4.4 (or later) 4.2. Screen size of at least 4.7 inches (equivalent to an iPhone 6) 5. Able to read and write in English (Information will be provided in the Welsh language if requested for the Welsh site) 6. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Systemic anti-cancer treatment to palliate incurable cancer for this malignancy 2. No longer undergoing systemic therapy 3. No smartphone access 4. Unable to read or write in English 5. Significant cognitive impairment

Design outcomes

Primary

MeasureTime frame
1. Health-related QoL measured using FACT-G (PWB) at baseline, (then 6, 12, 18) and 24 weeks

Secondary

MeasureTime frame
1.1. Patient compliance with patient-reported outcome (PRO) data collection measured using FACT-G (PWB), EQ5D, QLQ-C30 at baseline, then 6, 12, 18 and 24 weeks 1.2. Patient self-management of symptoms measured using EQ-5D-5L and EORTC QLQ-C30 at baseline, then 6, 12, 18 and 24 weeks 2. Process of care and emergency healthcare utilisation (medication adherence, A&E/GP visits/admissions, acute oncology hotline utilisation, concomitant medications) measured by asking participants (at their clinic visits) and reviewing their medical records at baseline, then 6, 12, 18 and 24 weeks

Countries

England, United Kingdom, Wales

Contacts

Public ContactAgnieszka Michael
a.michael@surrey.ac.uk+44 (0)1483688546

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026