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Register:	ISRCTN
Last refreshed on:	17 October 2022
Main ID:	ISRCTN18676721
Date of registration:	02/05/2018
Prospective Registration:	No
Primary sponsor:	National University of Ireland, Galway
Public title:	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
Scientific title:	A pilot trial evaluating an intervention using Behaviour Change Techniques (information, goal-setting, graded tasks, self-monitoring, review and feedback) and mobile technology versus standard care to increase physical activity, reduce BMI, and improve the health and wellbeing of overweight/obese cancer survivors
Date of first enrolment:	01/12/2017
Target sample size:	120
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN18676721
Study type:	Interventional
Study design:	Randomised controlled trial (Other)
Phase:	Not Applicable

Countries of recruitment
Ireland

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Jenny Groarke
Address:	School of Psychology University Road NUI, Galway 091 Galway Ireland
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Overweight/obese cancer survivors
Nutritional, Metabolic, Endocrine
Obesity

Intervention(s)

The study is employing a 2 groups (experimental and control) x 3 time-points (baseline, 3 months, 6 months) mixed Analysis of Variance design to investigate the impact of a personalised solution versus standard care on primary and secondary health outcomes. Participants are randomly allocated to control or intervention group.

Participants in the intervention condition will wear a Fitbit activity monitor for the duration of the 6-month study. Summary data will be visible on the tracker’s display and additional physical activity (step count) and sleep data will be available on the Fitbit application for the study condition. The FitBit device allows for an assessment of the behaviour change strategies of self-monitoring, combined with other self-regulatory skills (e.g., goal setting, frequent behavioural feedback) (Cadmus-Bertram, et al., 2015). The experimental group will received a personalised dietary and physical activity intervention which will employ an educational component along with a shared decision-making and a goal-setting model. The self management programme is interdisciplinary in nature and will be delivered by a host of healthcare professionals (Nurses, Physiotherapists, Dieticians, and Psychologists). Participants will attend group educational sessions (n=15 approx per group). In these sessions, lifestyle education and advice will be given with an opportunity for individualised advice/support. This self-management programme will provide the structure for interventions to include imparting knowledge, empowering an individual to make lifestyle change, motivating behavioural change and sustaining such positive lifestyle choices going forward.

Weekly goals and overall targets for physical activity will be agre

Primary Outcome(s)

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

Secondary Outcome(s)

1. Sleep quality, measured via Fitbit device continuously for 6 months
The following measures are recorded at baseline, three month follow-up (Time 1), and six month follow-up (Time 2):
2. Physical fitness, measured using 6-minute walk test - resting HR, BP, Sp02, recovery HR, BP, Sp02
3. Dietary behaviour, measured using Food Frequency Questionnaire (Mulligan, Luben, Bhaniani et al., 2014)
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)

Secondary ID(s)

LET17RIC

Source(s) of Monetary Support

Irish Cancer Society

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

National University of Ireland, Galway Research Ethics Committee, 12/09/2017, ref: 17-May-20

Results

Results available:	Yes
Date Posted:
Date Completed:	13/09/2018
URL:

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