CanWalk: study protocol for a randomized feasibility trial of a walking intervention for people with recurrent or metastatic cancerReport as inadecuate




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Pilot and Feasibility Studies

, 1:7

First Online: 12 March 2015Received: 10 November 2014Accepted: 11 February 2015DOI: 10.1186-s40814-015-0003-5

Cite this article as: Harris, J., Tsianakas, V., Ream, E. et al. Pilot Feasibility Stud 2015 1: 7. doi:10.1186-s40814-015-0003-5

Abstract

BackgroundIncreasing numbers of people in the UK are living with recurrent or metastatic cancer, many of whom experience reduced quality of life resulting from the physical and psychosocial consequences of cancer and its treatment. While drug treatments are important at alleviating some symptoms, there is increasing evidence of the benefits of exercise in enhancing quality of life and health outcomes. Walking is an inexpensive and accessible form of exercise. To our knowledge, no studies have investigated whether a walking intervention is sufficient to enhance quality of life and alleviate symptoms in people with recurrent or metastatic cancer across a range of tumor types. This paper describes the CanWalk study protocol, which aims to assess the feasibility and acceptability of undertaking a randomized controlled trial of a community-based walking program to enhance quality of life and well-being in people with recurrent or metastatic cancer.

MethodsA mixed methods feasibility study includes an exploratory two-center randomized controlled trial and qualitative interviews. A minimum of 60 participants will be recruited from two London NHS Trusts and randomized 1:1 between the walking intervention and standard care using minimization. The walking intervention consists of the initial provision of written-online information followed by a short motivational interview. Participants are instructed to walk for 30 min on alternate days and attend an organized volunteer-led walk once a week. Half of all participants will be asked to use a pedometer. Postal questionnaires will be completed at baseline pre-randomization and at 6, 12 and 24 weeks. A subsample of participants and stakeholders will be interviewed at the end of the study.

ResultsPrimary outcomes will be the acceptability and feasibility of the intervention and trial. A range of secondary outcome assessments needed to design a main study, including estimates of recruitment, adherence and variability in quality of life, will be evaluated.

ConclusionsData from this study will be used to refine the walking intervention, investigate the acceptability of the intervention and study design, and determine the most appropriate outcome measures thereby providing estimates of the factors needed to design the main study.

Trial registrationISRCTN42072606.

KeywordsRandomized controlled trial Feasibility studies Qualitative evaluation Metastatic cancer Recurrent cancer Secondary cancer Walking AbbreviationsQoLquality of life

NHSNational Health Service

NRESNational Research Ethics Service

NICENational Institute for Health and Clinical Excellence

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Author: Jenny Harris - Vicki Tsianakas - Emma Ream - Mieke Van Hemelrijck - Arnie Purushotham - Lorelei Mucci - James SA Green - K

Source: https://link.springer.com/







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