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Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial
BACKGROUND: Peer-based exercise interventions that cultivate new opportunities for support with a fellow cancer survivor may result in increased exercise volume. It is not clear whether adding qualified exercise professional (QEP) support to peer-based interventions improves health outcomes. Therefo...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8515152/ https://www.ncbi.nlm.nih.gov/pubmed/34649590 http://dx.doi.org/10.1186/s13102-021-00341-w |
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author | Smith-Turchyn, Jenna McCowan, Michelle E. O’Loughlin, Erin Fong, Angela J. McDonough, Meghan H. Santa Mina, Daniel Arbour-Nicitopoulos, Kelly P. Trinh, Linda Jones, Jennifer M. Bender, Jackie L. Culos-Reed, S. Nicole Tomasone, Jennifer R. Vani, Madison F. Sabiston, Catherine M. |
author_facet | Smith-Turchyn, Jenna McCowan, Michelle E. O’Loughlin, Erin Fong, Angela J. McDonough, Meghan H. Santa Mina, Daniel Arbour-Nicitopoulos, Kelly P. Trinh, Linda Jones, Jennifer M. Bender, Jackie L. Culos-Reed, S. Nicole Tomasone, Jennifer R. Vani, Madison F. Sabiston, Catherine M. |
author_sort | Smith-Turchyn, Jenna |
collection | PubMed |
description | BACKGROUND: Peer-based exercise interventions that cultivate new opportunities for support with a fellow cancer survivor may result in increased exercise volume. It is not clear whether adding qualified exercise professional (QEP) support to peer-based interventions improves health outcomes. Therefore, the purpose of this study is to determine whether breast cancer survivor (BCS) dyads who receive 10 weekly sessions of virtually delivered QEP support have improved outcomes compared to BCS dyads who do not receive QEP support. METHODS: Participants Adult BCS with medical clearance for exercise, who have an internet-connected device, and currently engage in < 150 min of moderate-intensity exercise per week. Intervention BCS will be matched using evidence-based criteria. The intervention group will receive dyadic exercise information sessions and a program tailored by a QEP for 10 weeks (intervention period) and have access to the QEP for an additional 4 weeks (tapering period). The control will not receive any QEP support. Outcomes The primary outcome is post-intervention self-reported exercise volume. Secondary outcomes include device-assessed exercise volume (i.e., Fitbit), social support, and health-related quality of life. Randomization 108 participants, matched in dyads, will be randomized 1:1 to the MatchQEP or Match groups using a web-based scheme. Statistical analysis Outcomes will be measured at baseline, post-intervention, post-tapering, and at 12 weeks post-intervention follow-up. DISCUSSION: The findings from this RCT will determine if matched BCS dyads who receive 10 weeks of virtually delivered QEP support have higher levels of self-report and device-measured exercise, social support, and health related quality of life compared to matched dyads without QEP-delivered exercise guidance. To our knowledge this will be the first study to assess the combined effect of peer- and QEP support on exercise volume. Project findings will inform and optimize intervention methods aimed to increase exercise among BCS through accessible exercise supports. Trial Registration: The study is registered on ClinicalTrials.gov (study identifier: NCT04771975, protocol Version Number: 2, date: July 22, 2021). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13102-021-00341-w. |
format | Online Article Text |
id | pubmed-8515152 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-85151522021-10-14 Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial Smith-Turchyn, Jenna McCowan, Michelle E. O’Loughlin, Erin Fong, Angela J. McDonough, Meghan H. Santa Mina, Daniel Arbour-Nicitopoulos, Kelly P. Trinh, Linda Jones, Jennifer M. Bender, Jackie L. Culos-Reed, S. Nicole Tomasone, Jennifer R. Vani, Madison F. Sabiston, Catherine M. BMC Sports Sci Med Rehabil Study Protocol BACKGROUND: Peer-based exercise interventions that cultivate new opportunities for support with a fellow cancer survivor may result in increased exercise volume. It is not clear whether adding qualified exercise professional (QEP) support to peer-based interventions improves health outcomes. Therefore, the purpose of this study is to determine whether breast cancer survivor (BCS) dyads who receive 10 weekly sessions of virtually delivered QEP support have improved outcomes compared to BCS dyads who do not receive QEP support. METHODS: Participants Adult BCS with medical clearance for exercise, who have an internet-connected device, and currently engage in < 150 min of moderate-intensity exercise per week. Intervention BCS will be matched using evidence-based criteria. The intervention group will receive dyadic exercise information sessions and a program tailored by a QEP for 10 weeks (intervention period) and have access to the QEP for an additional 4 weeks (tapering period). The control will not receive any QEP support. Outcomes The primary outcome is post-intervention self-reported exercise volume. Secondary outcomes include device-assessed exercise volume (i.e., Fitbit), social support, and health-related quality of life. Randomization 108 participants, matched in dyads, will be randomized 1:1 to the MatchQEP or Match groups using a web-based scheme. Statistical analysis Outcomes will be measured at baseline, post-intervention, post-tapering, and at 12 weeks post-intervention follow-up. DISCUSSION: The findings from this RCT will determine if matched BCS dyads who receive 10 weeks of virtually delivered QEP support have higher levels of self-report and device-measured exercise, social support, and health related quality of life compared to matched dyads without QEP-delivered exercise guidance. To our knowledge this will be the first study to assess the combined effect of peer- and QEP support on exercise volume. Project findings will inform and optimize intervention methods aimed to increase exercise among BCS through accessible exercise supports. Trial Registration: The study is registered on ClinicalTrials.gov (study identifier: NCT04771975, protocol Version Number: 2, date: July 22, 2021). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13102-021-00341-w. BioMed Central 2021-10-14 /pmc/articles/PMC8515152/ /pubmed/34649590 http://dx.doi.org/10.1186/s13102-021-00341-w Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Smith-Turchyn, Jenna McCowan, Michelle E. O’Loughlin, Erin Fong, Angela J. McDonough, Meghan H. Santa Mina, Daniel Arbour-Nicitopoulos, Kelly P. Trinh, Linda Jones, Jennifer M. Bender, Jackie L. Culos-Reed, S. Nicole Tomasone, Jennifer R. Vani, Madison F. Sabiston, Catherine M. Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial |
title | Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial |
title_full | Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial |
title_fullStr | Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial |
title_full_unstemmed | Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial |
title_short | Connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial |
title_sort | connecting breast cancer survivors for exercise: protocol for a two-arm randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8515152/ https://www.ncbi.nlm.nih.gov/pubmed/34649590 http://dx.doi.org/10.1186/s13102-021-00341-w |
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