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

NCT03036436 | Unknown

• 1 other identifier: IMPETUS-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cancer, Colorectal; Malignancy

Keywords

Cancer; EHealth; Cancer Survivor; Rehabilitation

Outcome Measures

Primary Outcomes (14)

• Change in Physical Activity (Objective)

  Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.

  Baseline, 12 weeks, 24 weeks

• Evaluation of recruitment capability and resulting sample characteristics

  The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.

  12 weeks

• Data collection procedures and outcome measures

  Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes

  12 weeks

• Acceptability and suitability of the intervention and study procedures

  Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed

  12 weeks

• Use of resources and ability to manage and implement the study and intervention

  The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention

  12 weeks

• Preliminary evaluation of participant responses to intervention

  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).

  12 weeks

• Change in body composition

  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.

  Baseline, 12 weeks and 24 weeks

• Change in self-report PA

  A modified version of the Godin Leisure Time Exercise Questionnaire will be used.

  Baseline, 12 weeks and 24 weeks

• Change in quality of life

  The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.

  Baseline, 12 weeks and 24 weeks

• Change in aerobic capacity/endurance

  This will be measured using the 6MWT (Six minute walk test).

  Baseline,12 weeks and 24 weeks

• Change in BMI

  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.

  Baseline, 12 weeks and 24 weeks

• Change in Body Weight (kg)

  This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.

  Baseline,12 weeks and 24 weeks

• Change in waist circumference

  This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.

  Baseline,12 weeks and 24 weeks

• Change in quality of life

  The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.

  Baseline,12 weeks and 24 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

St. James's Hospital Dublin

Dublin, Ireland

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 23512568 BACKGROUND

• 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.

  PMID: 4053261 BACKGROUND

• 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.

  PMID: 8445433 BACKGROUND

• 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.

  PMID: 1285753 BACKGROUND

• 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.

  PMID: 14131272 BACKGROUND

• 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.

  PMID: 30852540 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ciaran Haberlin, BSc(Physiotherapy)

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Chartered Physiotherapist

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 30, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

IE (1)