A pilot trial to investigate the impact of a personalised self-management lifestyle programme using mobile technology on the health and wellbeing of cancer survivors

Not Applicable

Completed

• Conditions: Overweight/obese cancer survivors; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN18676721
• Lead Sponsor: ational University of Ireland, Galway

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31444876/ (added 05/10/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33591290/ Acceptability (added 05/10/2022) 2021 Results article in https://doi.org/10.2196/24915 Effectiveness (added 05/10/2022)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-02
• Study Completion: 2018-09-13
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Adults with a solid cancer diagnosis with a calculated BMI > 25 post completion of acute cancer treatment who attend Oncology in Letterkenny University Hospital during the recruitment phase

Exclusion Criteria

1. <18 years old or >70 years old
2. Performance status of 2 or more (ECOG scale)
3. Terminally unwell
4. Those who do not wish to use mobile technology
5. Those whose English is not of sufficient standard to provide informed consent or receive education

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Average daily step count, measured via Fitbit device continuously for 6 months<br> 2. BMI and weight, recorded at baseline, three month follow-up (Time 1), and six month follow-up (Time 2)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Sleep quality, measured via Fitbit device continuously for 6 months<br> The following measures are recorded at baseline, three month follow-up (Time 1), and six month follow-up (Time 2):<br> 2. Physical fitness, measured using 6-minute walk test - resting HR, BP, Sp02, recovery HR, BP, Sp02<br> 3. Dietary behaviour, measured using Food Frequency Questionnaire (Mulligan, Luben, Bhaniani et al., 2014)<br> 4. General health status (MOS SF-36; Ware et al, 2000), fatigue (Mendoza, Wang, Cleeland, et al., 1999), self-efficacy (Schwarzer & Jerusalem, 2010), exercise self-efficacy (Bandura, 2006), exercise-related social support (Sallis et al., 1987)<br>