<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036436</url>
  </required_header>
  <id_info>
    <org_study_id>IMPETUS-01</org_study_id>
    <nct_id>NCT03036436</nct_id>
  </id_info>
  <brief_title>The IMPETUS Cancer Trial. A Technology Delivered Physical Activity Intervention in Cancer</brief_title>
  <acronym>IMPETUS</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Dublin, Trinity College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Dublin, Trinity College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants will take part in a 12 week intervention, with at least one follow up at 24 +/-&#xD;
      2 weeks. Each participant will be provided with support, motivation and professional guidance&#xD;
      about improving physical activity (PA) levels and will be given a commercially available PA&#xD;
      tracker. The PA tracker will also include a smartphone or web-based application, where&#xD;
      participants can upload their exercise performed each day, and keep up to date with their&#xD;
      goals using their smartphone or by logging on to their computer. The aim of the study is to&#xD;
      find out how useful and effective technology with support from a healthcare professional is&#xD;
      in helping cancer survivors to become more physically active.&#xD;
&#xD;
      This study will measure objective PA levels of the participants at the start of the study and&#xD;
      at the end. The acceptability of using this intervention to promote PA in cancer survivors&#xD;
      will also be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall aim is to determine the feasibility of a specific PA intervention, combining&#xD;
      technology and professional input, in the cancer survivor population.&#xD;
&#xD;
      Study Design: A single arm feasibility trial of a PA intervention using technology and&#xD;
      behavioural change theories as tools to achieve increased PA. Participants in the study will&#xD;
      receive 12 weeks of the intervention. Outcomes will be measured at baseline, 12 weeks and 24&#xD;
      weeks (+/- 2 weeks) post baseline.&#xD;
&#xD;
      Patient recruitment: Participants will be recruited from those attending the St. James'&#xD;
      Hospital oncology and haematology services. Study personnel will provide further information&#xD;
      to these patients and assess them for eligibility. Informed consent will be gained from each&#xD;
      participant.&#xD;
&#xD;
      Sample size: Proposed sample size is 60 (based on Sim and Lewis, 2012 recommendations) and&#xD;
      allowing for 20% drop-out.&#xD;
&#xD;
      Intervention: This study will use the commercially available 'Fitbit' wearable technology&#xD;
      with its paired smartphone application. PA goals will be prescribed by a qualified, chartered&#xD;
      physiotherapist using the American Cancer Society (ACS) guidelines (Doyle et al 2006).&#xD;
      Participants will use the Fitbit and its paired application for 12 weeks. The Fitbit device&#xD;
      is a tool for motivation and monitoring of PA behaviours in this intervention.&#xD;
&#xD;
      This study will also use evidence-based psychological behavioural change theory. Behavioural&#xD;
      change techniques include 'self-monitoring of behaviour', 'goal-setting', 'feedback on&#xD;
      behaviour' and 'information about health consequences'.&#xD;
&#xD;
      Procedures: This study includes time-points at baseline, 12 weeks (Intervention end) and 24&#xD;
      weeks post baseline (+/- 2 weeks (Follow-up).&#xD;
&#xD;
      Pre-intervention:Consent and PA measurement&#xD;
&#xD;
        -  Consent: Study personnel meets potential participants at their outpatient appointment.&#xD;
           The agreement of the patient's consultant to exercise has been obtained before the&#xD;
           patient information leaflet (PIL) is provided. The researcher explains the study and&#xD;
           gives the potential participant a consent form and a patient information leaflet and a&#xD;
           verbal explanation of the study.&#xD;
&#xD;
        -  Initial PA measurement: Participants who consent are given an Actigraph PA monitor which&#xD;
           they will be instructed to wear for 7 days to measure their baseline physical activity&#xD;
           levels. Participants who wish to consider the study can take the PIL home, post it back,&#xD;
           and receive the Actigraph by post.&#xD;
&#xD;
      Baseline Session:&#xD;
&#xD;
      Participants attend&#xD;
&#xD;
        -  1) An educational session, delivered by the lead researcher, a chartered&#xD;
           physiotherapist. This is a group information session on PA following cancer treatment.&#xD;
&#xD;
        -  2) Educational session to introduce the technological component to the participants and&#xD;
           instruct them in use and upload of Fitbit data to allow monitoring by researcher(s).&#xD;
&#xD;
        -  3) Measurement of height, weight, BMI and body composition and 6 minute walk test During&#xD;
           intervention. (week 1-12)&#xD;
&#xD;
        -  Participants wear Fitbit and upload data for self-monitoring and monitoring by chartered&#xD;
           physiotherapist researcher.&#xD;
&#xD;
        -  Participants receive scheduled structured telephone calls, giving them feedback on their&#xD;
           achievement of goals and reminders about uploading data as follows; 2 calls each week&#xD;
           till week 4, 1 call a week between week 4 and 8 and 2 calls, 2 weeks apart between week&#xD;
           8 and week 12.&#xD;
&#xD;
      After intervention ends (12 weeks):&#xD;
&#xD;
        -  Measurement of height, weight, BMI and body composition and 6 minute walk test&#xD;
&#xD;
        -  Participants wear Actigraph x 7 days&#xD;
&#xD;
           12 weeks after end of intervention:&#xD;
&#xD;
        -  Measurement of height, weight, BMI and body composition and 6 minute walk test&#xD;
&#xD;
        -  Participants wear Actigraph x 7 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Physical Activity (Objective)</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of recruitment capability and resulting sample characteristics</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Data collection procedures and outcome measures</measure>
    <time_frame>12 weeks</time_frame>
    <description>Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability and suitability of the intervention and study procedures</measure>
    <time_frame>12 weeks</time_frame>
    <description>Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of resources and ability to manage and implement the study and intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preliminary evaluation of participant responses to intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>Baseline, 12 weeks and 24 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-report PA</measure>
    <time_frame>Baseline, 12 weeks and 24 weeks</time_frame>
    <description>A modified version of the Godin Leisure Time Exercise Questionnaire will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline, 12 weeks and 24 weeks</time_frame>
    <description>The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in aerobic capacity/endurance</measure>
    <time_frame>Baseline,12 weeks and 24 weeks</time_frame>
    <description>This will be measured using the 6MWT (Six minute walk test).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in BMI</measure>
    <time_frame>Baseline, 12 weeks and 24 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Body Weight (kg)</measure>
    <time_frame>Baseline,12 weeks and 24 weeks</time_frame>
    <description>This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Baseline,12 weeks and 24 weeks</time_frame>
    <description>This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline,12 weeks and 24 weeks</time_frame>
    <description>The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cancer, Breast</condition>
  <condition>Cancer, Colorectal</condition>
  <condition>Malignancy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agreement of the participant's cancer clinician that he/she can participate, including&#xD;
             medical clearance to exercise&#xD;
&#xD;
          -  Aged &gt;18 years&#xD;
&#xD;
          -  Completed chemotherapy or radiotherapy with curative intent within the preceding 3&#xD;
             years. Patients may have had chemotherapy or radiotherapy as the sole treatment for&#xD;
             cancer, but not surgery alone. Patients who are still on adjuvant hormone therapy&#xD;
             and/or adjuvant Her2-directed therapy are eligible (with physician agreement as&#xD;
             above).&#xD;
&#xD;
          -  Able to understand English&#xD;
&#xD;
          -  Owns or has access to a device which is compatible with the Fitbit app i.e.&#xD;
             smartphone, tablet or computer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of prostate cancer or upper gastro-intestinal cancer.&#xD;
&#xD;
          -  Chronic medical and orthopaedic conditions that would preclude exercise (e.g&#xD;
             uncontrolled congestive heart failure or angina, recent MI within 6 months recent&#xD;
             Pulmonary embolism within 3 months, breathing difficulties requiring oxygen use or&#xD;
             hospitalization, osteoarthritis causing significant mobility issues).&#xD;
&#xD;
          -  Confirmed pregnancy&#xD;
&#xD;
          -  Dementia, cognitive impairment or psychiatric illness that would preclude ability to&#xD;
             participate in study.&#xD;
&#xD;
          -  Incomplete haematological recovery after chemotherapy (WCC &lt; 3, Hb &lt; 10 or Platelets &lt;&#xD;
             100).&#xD;
&#xD;
          -  Patients&lt;18 years&#xD;
&#xD;
          -  Evidence of active cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ciaran Haberlin, BSc(Physiotherapy)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Dublin, Trinity College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. James's Hospital Dublin</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <reference>
    <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>
    <PMID>22169081</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17135691</PMID>
  </reference>
  <reference>
    <citation>Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.</citation>
    <PMID>6863699</PMID>
  </reference>
  <reference>
    <citation>Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ, US, Prentice-Hall, Inc.</citation>
  </reference>
  <reference>
    <citation>Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.</citation>
    <PMID>23512568</PMID>
  </reference>
  <reference>
    <citation>Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.</citation>
    <PMID>4053261</PMID>
  </reference>
  <reference>
    <citation>Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.</citation>
    <PMID>8445433</PMID>
  </reference>
  <reference>
    <citation>Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.</citation>
    <PMID>1285753</PMID>
  </reference>
  <reference>
    <citation>BALKE B. A SIMPLE FIELD TEST FOR THE ASSESSMENT OF PHYSICAL FITNESS. REP 63-6. Rep Civ Aeromed Res Inst US. 1963 Apr:1-8. No abstract available.</citation>
    <PMID>14131272</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>July 23, 2018</last_update_submitted>
  <last_update_submitted_qc>July 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Dublin, Trinity College</investigator_affiliation>
    <investigator_full_name>Ciaran Haberlin</investigator_full_name>
    <investigator_title>PhD Candidate, Chartered Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>EHealth</keyword>
  <keyword>Cancer Survivor</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036436
org study id: IMPETUS-01
nct id: NCT03036436
lead sponsor: 
has dmc: No
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.
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Physical Activity (Objective)
time frame: Baseline, 12 weeks, 24 weeks
description: Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.
measure: Evaluation of recruitment capability and resulting sample characteristics
time frame: 12 weeks
description: The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.
measure: Data collection procedures and outcome measures
time frame: 12 weeks
description: Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes
measure: Acceptability and suitability of the intervention and study procedures
time frame: 12 weeks
description: Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed
measure: Use of resources and ability to manage and implement the study and intervention
time frame: 12 weeks
description: The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention
measure: Preliminary evaluation of participant responses to intervention
time frame: 12 weeks
description: 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).
measure: Change in body composition
time frame: Baseline, 12 weeks and 24 weeks
description: 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.
measure: Change in self-report PA
time frame: Baseline, 12 weeks and 24 weeks
description: A modified version of the Godin Leisure Time Exercise Questionnaire will be used.
measure: Change in quality of life
time frame: Baseline, 12 weeks and 24 weeks
description: The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.
measure: Change in aerobic capacity/endurance
time frame: Baseline,12 weeks and 24 weeks
description: This will be measured using the 6MWT (Six minute walk test).
measure: Change in BMI
time frame: Baseline, 12 weeks and 24 weeks
description: 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.
measure: Change in Body Weight (kg)
time frame: Baseline,12 weeks and 24 weeks
description: This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.
measure: Change in waist circumference
time frame: Baseline,12 weeks and 24 weeks
description: This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.
measure: Change in quality of life
time frame: Baseline,12 weeks and 24 weeks
description: The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.
arm group label: Intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Intervention
description: A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ciaran Haberlin, BSc(Physiotherapy)
role: Principal Investigator
affiliation: University of Dublin, Trinity College
facility: 
country: Ireland
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.
PMID: 22169081
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.
PMID: 17135691
citation: Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.
PMID: 6863699
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responsible party type: Principal Investigator
investigator affiliation: University of Dublin, Trinity College
investigator full name: Ciaran Haberlin
investigator title: PhD Candidate, Chartered Physiotherapist
mesh term: Breast Neoplasms
mesh term: Colorectal Neoplasms
sharing ipd: Undecided