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

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ClinicalTrials.gov Identifier: NCT03036436
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ciaran Haberlin, University of Dublin, Trinity College

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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Physical Activity (Objective) [ Time Frame: 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.

  2. Evaluation of recruitment capability and resulting sample characteristics [ Time Frame: 12 weeks ]
    The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.

  3. Data collection procedures and outcome measures [ Time Frame: 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

  4. Acceptability and suitability of the intervention and study procedures [ Time Frame: 12 weeks ]
    Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed

  5. Use of resources and ability to manage and implement the study and intervention [ Time Frame: 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

  6. Preliminary evaluation of participant responses to intervention [ Time Frame: 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).

  7. Change in body composition [ Time Frame: 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.

  8. Change in self-report PA [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    A modified version of the Godin Leisure Time Exercise Questionnaire will be used.

  9. Change in quality of life [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.

  10. Change in aerobic capacity/endurance [ Time Frame: Baseline,12 weeks and 24 weeks ]
    This will be measured using the 6MWT (Six minute walk test).

  11. Change in BMI [ Time Frame: 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.

  12. Change in Body Weight (kg) [ Time Frame: 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.

  13. Change in waist circumference [ Time Frame: 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.

  14. Change in quality of life [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036436


Locations
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Ireland
St. James's Hospital Dublin
Dublin, Ireland
Sponsors and Collaborators
University of Dublin, Trinity College
Investigators
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Principal Investigator: Ciaran Haberlin, BSc(Physiotherapy) Trinity College Dublin

Publications:
Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ, US, Prentice-Hall, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ciaran Haberlin, PhD Candidate, Chartered Physiotherapist, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT03036436     History of Changes
Other Study ID Numbers: IMPETUS-01
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ciaran Haberlin, University of Dublin, Trinity College:
Cancer
EHealth
Cancer Survivor
Rehabilitation

Additional relevant MeSH terms:
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Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases