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APPROACH: a mobile phone app to encourage increased health & wellbeing after cancer

APPROACH: an app for health & wellbeing after cancer – a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14149329
Enrollment
472
Registered
2023-09-11
Start date
2023-10-23
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Cancer Cancer

Interventions

Participants will be randomised into intervention or control groups using minimisation with a 1:1 allocation ratio. Stratification factors will be cancer type (breast, prostate or colorectal) and hosp

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: Note, points 1 and 2 are checked by the clinical care team in the initial medical record eligibility screening. 1. Diagnosed with breast, prostate or colorectal cancer within the last 2 and a half years at a participating hospital site 2. Aged 16 years or older 3. Own a smartphone (that uses Android or iOS (Apple) operating systems) 4. Willing and able to provide informed consent 5. Has access to a computer or tablet and an email address, and is willing to complete online questionnaires. 6. Willing to wear an accelerometer for a week at the assessment points

Exclusion criteria

Exclusion criteria: Note, points 1a, 4, 5, 6 and 13 are checked by the clinical care team in the initial medical record eligibility screening. 1. Patients who are more than 2 years post-diagnosis at the point of screening by hospital staff. Due to the potential time gap between screening/inviting participants and then consenting we will exclude patients who are more than 2 and a half years post-diagnosis at consent. 2. Unable to understand spoken/written English 3. ECOG status > 3 4. Diagnosed cognitive impairment (e.g. dementia) 5. Cognitive and/or physical impairment that prevents participation in brisk walking 6. Those who have a current diagnosis of metastatic disease 7. Due to have surgery to remove cancer in the next 5 months 8. < 6 weeks after surgery to remove cancer at consent 9. Reports achieving 150 minutes of at least moderate intensity PA weekly [80] 10. Report previous/current use of the study app app 11. Current participation in a health behaviour change study 12. Live with someone already participating in the trial 13. Incarcerated (i.e. address is a prison) 14. Already participated in the APPROACH pilot study (only applies at the pilot hospital site)

Design outcomes

Primary

MeasureTime frame
Daily average minutes of brisk walking (=100 steps per minute) measured using an objective measure (an activPAL accelerometer), worn for 7 days at baseline, 3 and 6 months

Secondary

MeasureTime frame
1. Average total steps, minutes of light physical activity, standing time and sitting time measured using an activPAL accelerometer at baseline, 3 and 6 months 2. Body Mass Index (BMI) self-reported using scales provided by the study at baseline, 3 and 6 months 3. Waist circumference self-reported using tape measure provided by the study at baseline, 3 and 6 months 4. Self-reported physical activity measured using the Godin Leisure Time Exercise Questionnaire (GLTEQ) at baseline, 3 and 6 months 5. Self-reported health status (using the five-level EuroQol-5D questionnaire,EQ-5D-5L), cancer-specific quality of life (using the Functional Assessment of Cancer Therapy-general, FACT-G), fatigue (FACT-F), sleep quality (Pittsburgh Sleep Quality Index, PSQI), anxiety (Generalised Anxiety Disorder Assessment, GAD-7), depression (Patient Health Questionnaire, PHQ-9), social support (brief form of the Perceived Social Support Questionnaire, F-Soz-UK-6), self-efficacy to manage cancer (Cancer Survivorship Self-Efficacy Scale, CS-SES) and physical activity self-efficacy (Physical Activity Appraisal Inventory, PAAI) at baseline, 3 and 6 months 6. Habit strength for walking measured using the Self-Report Behavioural Automaticity Index (SRBAI) at baseline, 3 and 6 months 7. App usage (in the intervention group) measured using questions from the Digital Behaviour Change Interventions Engagement Scale at 3 and 6 months 8. Health and social care service use measured using the Client Service Receipt Inventory (CSRI) at baseline, 3 and 6 months 9. Hospital service use measured using medical records over the 30 weeks after randomisation

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026