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CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer

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)...

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Autores principales: Tsianakas, Vicki, Harris, Jenny, Ream, Emma, Van Hemelrijck, Mieke, Purushotham, Arnie, Mucci, Lorelei, Green, James S A, Fewster, Jacquetta, Armes, Jo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5318561/
https://www.ncbi.nlm.nih.gov/pubmed/28202500
http://dx.doi.org/10.1136/bmjopen-2016-013719
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author Tsianakas, Vicki
Harris, Jenny
Ream, Emma
Van Hemelrijck, Mieke
Purushotham, Arnie
Mucci, Lorelei
Green, James S A
Fewster, Jacquetta
Armes, Jo
author_facet Tsianakas, Vicki
Harris, Jenny
Ream, Emma
Van Hemelrijck, Mieke
Purushotham, Arnie
Mucci, Lorelei
Green, James S A
Fewster, Jacquetta
Armes, Jo
author_sort Tsianakas, Vicki
collection PubMed
description 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.
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spelling pubmed-53185612017-02-27 CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer Tsianakas, Vicki Harris, Jenny Ream, Emma Van Hemelrijck, Mieke Purushotham, Arnie Mucci, Lorelei Green, James S A Fewster, Jacquetta Armes, Jo BMJ Open Oncology 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. BMJ Publishing Group 2017-02-15 /pmc/articles/PMC5318561/ /pubmed/28202500 http://dx.doi.org/10.1136/bmjopen-2016-013719 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ 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/
spellingShingle Oncology
Tsianakas, Vicki
Harris, Jenny
Ream, Emma
Van Hemelrijck, Mieke
Purushotham, Arnie
Mucci, Lorelei
Green, James S A
Fewster, Jacquetta
Armes, Jo
CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
title CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
title_full CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
title_fullStr CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
title_full_unstemmed CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
title_short CanWalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
title_sort canwalk: a feasibility study with embedded randomised controlled trial pilot of a walking intervention for people with recurrent or metastatic cancer
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5318561/
https://www.ncbi.nlm.nih.gov/pubmed/28202500
http://dx.doi.org/10.1136/bmjopen-2016-013719
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