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Oncology
Research
CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
  1. Vicki Tsianakas1,
  2. Jenny Harris1,
  3. Emma Ream2,
  4. Mieke Van Hemelrijck3,
  5. Arnie Purushotham4,
  6. Lorelei Mucci5,
  7. James S A Green6,7,
  8. Jacquetta Fewster8,
  9. Jo Armes1
  1. 1Florence Nightingale Faculty of Nursing and Midwifery, Kings College London, Kings Health Partners, London, UK
  2. 2Faculty of Health and Medical Sciences, University of Surrey, School of Health Sciences, Guildford, UK
  3. 3Division of Cancer Studies, Cancer Epidemiology Group, King's College London, Kings Health Partners, London, UK
  4. 4Division of Cancer Studies, Cancer Epidemiology Group, King's College London, Guys Hospital, UK
  5. 5Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, Massachusetts, USA
  6. 6Department of Urology, Whipps Cross University Hospital, Barts Health NHS Trust, London, UK
  7. 7London South Bank University, London, UK
  8. 8Wellbeing and Support Department, Macmillan Cancer Support, Physical Activity Team, London, UK
  1. Correspondence to Dr Jo Armes; jo.armes{at}kcl.ac.uk

Abstract

Objectives Walking is an adaptable, inexpensive and accessible form of physical activity. However, its impact on quality of life (QoL) and symptom severity in people with advanced cancer is unknown. This study aimed to assess the feasibility and acceptability of a randomised controlled trial (RCT) of a community-based walking intervention to enhance QoL in people with recurrent/metastatic cancer.

Design We used a mixed-methods design comprising a 2-centre RCT and nested qualitative interviews.

Participants Patients with advanced breast, prostate, gynaecological or haematological cancers randomised 1:1 between intervention and usual care.

Intervention The intervention comprised Macmillan's ‘Move More’ information, a short motivational interview with a recommendation to walk for at least 30 min on alternate days and attend a volunteer-led group walk weekly.

Outcomes We assessed feasibility and acceptability of the intervention and RCT by evaluating study processes (rates of recruitment, consent, retention, adherence and adverse events), and using end-of-study questionnaires and qualitative interviews. Patient-reported outcome measures (PROMs) assessing QoL, activity, fatigue, mood and self-efficacy were completed at baseline and 6, 12 and 24 weeks.

Results We recruited 42 (38%) eligible participants. Recruitment was lower than anticipated (goal n=60), the most commonly reported reason being unable to commit to walking groups (n=19). Randomisation procedures worked well with groups evenly matched for age, sex and activity. By week 24, there was a 45% attrition rate. Most PROMs while acceptable were not sensitive to change and did not capture key benefits.

Conclusions The intervention was acceptable, well tolerated and the study design was judged acceptable and feasible. Results are encouraging and demonstrate that exercise was popular and conveyed benefit to participants. Consequently, an effectiveness RCT is warranted, with some modifications to the intervention to include greater tailoring and more appropriate PROMs selected.

Trial registration number ISRCTN42072606.

  • feasibility studies
  • quality of life
  • walking
  • metastatic and recurrent cancer
  • randomised controlled trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-013719

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    Footnotes

    • Twitter Follow Vicki Tsianakas, Jenny Harris and Jo Armes @CancerCareKCL

    • Contributors VT and JH recruited participants and were responsible for day-to-day study coordination, delivery of the intervention and drafted the manuscript. JA is the study chief investigator and provided the concept, hypotheses, study design and methods, recruitment of participants, is responsible for the overall study management and drafted and critically revised the manuscript. ER, MVH, AP, LM, JSAG and JF participated in the design of the study, critically revised the protocol and the manuscript. All authors read and approved the final manuscript.

    • Funding This work was supported by Dimbleby Cancer Care. The full study report was submitted to the funding body—Dimbleby Cancer Care—in 2015.

    • Disclaimer The study was designed and conceived independently of the study funder and sponsor, and neither had any role in the collection, management, analysis, interpretation of the data or writing of the full report.

    • Competing interests None declared.

    • Ethics approval Ethical approval was gained from the National Research Ethics Service (Ref. 13/NW/0860) and research governance approval granted by both NHS Trusts.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.