The IMPETUS Cancer Trial. A Technology Delivered Physical Activity Intervention in Cancer

Sponsor

University of Dublin, Trinity College (Other)

Overall Status

Unknown status

CT.gov ID

NCT03036436

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast Cancer, Colorectal Malignancy	Behavioral: Intervention	N/A

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.
1. 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).
1. 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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)

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants in this group will receive the intervention. They will receive a Fitbit activity tracker, and will also receive support and goal setting with a view to improving their daily physical activity.	Behavioral: Intervention A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.

Arm

Intervention/Treatment

Experimental: Intervention

Participants in this group will receive the intervention. They will receive a Fitbit activity tracker, and will also receive support and goal setting with a view to improving their daily physical activity.

Behavioral: Intervention

A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.

Outcome Measures

Primary Outcome Measures

Change in Physical Activity (Objective) [Baseline, 12 weeks, 24 weeks]
Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.
Evaluation of recruitment capability and resulting sample characteristics [12 weeks]
The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.
Data collection procedures and outcome measures [12 weeks]
Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes
Acceptability and suitability of the intervention and study procedures [12 weeks]
Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed
Use of resources and ability to manage and implement the study and intervention [12 weeks]
The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention
Preliminary evaluation of participant responses to intervention [12 weeks]
The qualitative outcome in this feasibility study will invite participants' to provide feedback on the intervention's likelihood of being successful. Satisfaction with the technological intervention will be measured using a questionnaire given to participants at study end (12 weeks).
Change in body composition [Baseline, 12 weeks and 24 weeks]
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in percentage body fat.
Change in self-report PA [Baseline, 12 weeks and 24 weeks]
A modified version of the Godin Leisure Time Exercise Questionnaire will be used.
Change in quality of life [Baseline, 12 weeks and 24 weeks]
The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.
Change in aerobic capacity/endurance [Baseline,12 weeks and 24 weeks]
This will be measured using the 6MWT (Six minute walk test).
Change in BMI [Baseline, 12 weeks and 24 weeks]
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg/m^2.
Change in Body Weight (kg) [Baseline,12 weeks and 24 weeks]
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.
Change in waist circumference [Baseline,12 weeks and 24 weeks]
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.
Change in quality of life [Baseline,12 weeks and 24 weeks]
The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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