Clinical trial NCT03036436: The IMPETUS Cancer Trial. A Technology Delivered Physical Activity Intervention in Cancer
Official title: Investigating the Feasibility and Acceptability of a Technology Delivered Physical Activity (PA) Intervention in Cancer: The IMPETUS Cancer Trial. (IMproving Physical Activity and Exercise With Technology Use in Cancer Survivors)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Breast
Cancer, Colorectal
Malignancy
Keywords: Cancer
EHealth
Cancer Survivor
Rehabilitation
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. The PA tracker will also include a smartphone or web-based application, where participants can upload their exercise performed each day, and keep up to date with their goals using their smartphone or by logging on to their computer. The aim of the study is to find out how useful and effective technology with support from a healthcare professional is in helping cancer survivors to become more physically active.

This study will measure objective PA levels of the participants at the start of the study and at the end. The acceptability of using this intervention to promote PA in cancer survivors will also be investigated.

Detailed description: The overall aim is to determine the feasibility of a specific PA intervention, combining technology and professional input, in the cancer survivor population.

Study Design: A single arm feasibility trial of a PA intervention using technology and behavioural change theories as tools to achieve increased PA. Participants in the study will receive 12 weeks of the intervention. Outcomes will be measured at baseline, 12 weeks and 24 weeks (+/- 2 weeks) post baseline.

Patient recruitment: Participants will be recruited from those attending the St. James' Hospital oncology and haematology services. Study personnel will provide further information to these patients and assess them for eligibility. Informed consent will be gained from each participant.

Sample size: Proposed sample size is 60 (based on Sim and Lewis, 2012 recommendations) and allowing for 20% drop-out.

Intervention: This study will use the commercially available 'Fitbit' wearable technology with its paired smartphone application. PA goals will be prescribed by a qualified, chartered physiotherapist using the American Cancer Society (ACS) guidelines (Doyle et al 2006). Participants will use the Fitbit and its paired application for 12 weeks. The Fitbit device is a tool for motivation and monitoring of PA behaviours in this intervention.

This study will also use evidence-based psychological behavioural change theory. Behavioural change techniques include 'self-monitoring of behaviour', 'goal-setting', 'feedback on behaviour' and 'information about health consequences'.

Procedures: This study includes time-points at baseline, 12 weeks (Intervention end) and 24 weeks post baseline (+/- 2 weeks (Follow-up).

Pre-intervention:Consent and PA measurement

* Consent: Study personnel meets potential participants at their outpatient appointment. The agreement of the patient's consultant to exercise has been obtained before the patient information leaflet (PIL) is provided. The researcher explains the study and gives the potential participant a consent form and a patient information leaflet and a verbal explanation of the study.
* Initial PA measurement: Participants who consent are given an Actigraph PA monitor which they will be instructed to wear for 7 days to measure their baseline physical activity levels. Participants who wish to consider the study can take the PIL home, post it back, and receive the Actigraph by post.

Baseline Session:

Participants attend

* 1) An educational session, delivered by the lead researcher, a chartered physiotherapist. This is a group information session on PA following cancer treatment.
* 2) Educational session to introduce the technological component to the participants and instruct them in use and upload of Fitbit data to allow monitoring by researcher(s).
* 3) Measurement of height, weight, BMI and body composition and 6 minute walk test During intervention. (week 1-12)
* Participants wear Fitbit and upload data for self-monitoring and monitoring by chartered physiotherapist researcher.
* Participants receive scheduled structured telephone calls, giving them feedback on their achievement of goals and reminders about uploading data as follows; 2 calls each week till week 4, 1 call a week between week 4 and 8 and 2 calls, 2 weeks apart between week 8 and week 12.

After intervention ends (12 weeks):

* Measurement of height, weight, BMI and body composition and 6 minute walk test
* Participants wear Actigraph x 7 days

  12 weeks after end of intervention:
* Measurement of height, weight, BMI and body composition and 6 minute walk test
* Participants wear Actigraph x 7 days

Eligibility criteria: Inclusion Criteria:

* Agreement of the participant's cancer clinician that he/she can participate, including medical clearance to exercise
* Aged \>18 years
* Completed chemotherapy or radiotherapy with curative intent within the preceding 3 years. Patients may have had chemotherapy or radiotherapy as the sole treatment for cancer, but not surgery alone. Patients who are still on adjuvant hormone therapy and/or adjuvant Her2-directed therapy are eligible (with physician agreement as above).
* Able to understand English
* Owns or has access to a device which is compatible with the Fitbit app i.e. smartphone, tablet or computer.

Exclusion Criteria:

* Diagnosis of prostate cancer or upper gastro-intestinal cancer.
* Chronic medical and orthopaedic conditions that would preclude exercise (e.g uncontrolled congestive heart failure or angina, recent MI within 6 months recent Pulmonary embolism within 3 months, breathing difficulties requiring oxygen use or hospitalization, osteoarthritis causing significant mobility issues).
* Confirmed pregnancy
* Dementia, cognitive impairment or psychiatric illness that would preclude ability to participate in study.
* Incomplete haematological recovery after chemotherapy (WCC \< 3, Hb \< 10 or Platelets \< 100).
* Patients\<18 years
* Evidence of active cancer

Primary outcomes:
measure: Change in Physical Activity (Objective)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Evaluation of recruitment capability and resulting sample characteristics
timeFrame: 12 weeks
measure: Data collection procedures and outcome measures
timeFrame: 12 weeks
measure: Acceptability and suitability of the intervention and study procedures
timeFrame: 12 weeks
measure: Use of resources and ability to manage and implement the study and intervention
timeFrame: 12 weeks
measure: Preliminary evaluation of participant responses to intervention
timeFrame: 12 weeks
measure: Change in body composition
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in self-report PA
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in quality of life
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in aerobic capacity/endurance
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change in BMI
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Body Weight (kg)
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change in waist circumference
timeFrame: Baseline,12 weeks and 24 weeks
measure: Change in quality of life
timeFrame: Baseline,12 weeks and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James's Hospital Dublin
Study officials:
affiliation: University of Dublin, Trinity College
name: Ciaran Haberlin, BSc(Physiotherapy)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
citation: Doyle C, Kushi LH, Byers T, Courneya KS, Demark-Wahnefried W, Grant B, McTiernan A, Rock CL, Thompson C, Gansler T, Andrews KS; 2006 Nutrition, Physical Activity and Cancer Survivorship Advisory Committee; American Cancer Society. Nutrition and physical activity during and after cancer treatment: an American Cancer Society guide for informed choices. CA Cancer J Clin. 2006 Nov-Dec;56(6):323-53. doi: 10.3322/canjclin.56.6.323.
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citation: Haberlin C, Broderick J, Guinan EM, Darker C, Hussey J, O'Donnell DM. eHealth-based intervention to increase physical activity levels in people with cancer: protocol of a feasibility trial in an Irish acute hospital setting. BMJ Open. 2019 Mar 8;9(3):e024999. doi: 10.1136/bmjopen-2018-024999.