Study protocol: a pilot quasi-experimental trial of tele-rehabilitation and tele-drain care post-mastectomy.
Breast cancer
Pilot trial
Tele-rehabilitation
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
01 Feb 2021
01 Feb 2021
Historique:
received:
09
07
2020
accepted:
18
01
2021
entrez:
1
2
2021
pubmed:
2
2
2021
medline:
2
2
2021
Statut:
epublish
Résumé
Breast cancer is the leading cancer affecting women in Singapore. Its survivors commonly experience decline in physical function and quality of life post-mastectomy, due to their upper limb morbidity and wound issues. Rehabilitation can address the aforementioned issues. When rehabilitation is accessible and easy to adhere, it can optimize recovery. Home-based tele-rehabilitation guided by healthcare professionals and self-managed by patients can potentially optimize the patients' adherence to rehabilitation and recovery. With that in mind, a team of breast cancer specialists (oncologists, nurses, and therapists) in Singapore has developed one of the first tele-rehabilitation systems for local women undergoing a unilateral mastectomy. To our knowledge, no such systems have been evaluated or proven effective as a treatment option among local breast cancer patients with acute disabilities. This is a pilot quasi-experimental trial that aims to evaluate the feasibility of tele-rehabilitation and tele-drain care compared to usual care. Up to 40 patients (20 per group) will be recruited for this trial. They will be assigned to an intervention group that receives rehabilitation via a tele-rehabilitation system or a control group that receives rehabilitation in person at their clinic. The primary outcome of this trial is rehabilitation participation (i.e., the time spent on rehabilitation). The secondary outcomes are upper extremity functioning, perceived health, and quality of life. As part of this pilot trial, patients who opt in for the tele-rehabilitation will be asked to share their experience with and thoughts on the tele-rehabilitation system. With the evidence obtained from the tele-rehabilitation patients of this trial, we will be able to improve the current system for our future trial. Further, our additional data on rehabilitation participation, physical function, and quality of life will help us design a sufficiently powered future main trial. The trial was approved by the National Healthcare Group's Domain Specific Review Board (#2019/00283) and registered with www.ClinicalTrials.gov (# NCT04269967 ) in February 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Breast cancer is the leading cancer affecting women in Singapore. Its survivors commonly experience decline in physical function and quality of life post-mastectomy, due to their upper limb morbidity and wound issues. Rehabilitation can address the aforementioned issues. When rehabilitation is accessible and easy to adhere, it can optimize recovery. Home-based tele-rehabilitation guided by healthcare professionals and self-managed by patients can potentially optimize the patients' adherence to rehabilitation and recovery. With that in mind, a team of breast cancer specialists (oncologists, nurses, and therapists) in Singapore has developed one of the first tele-rehabilitation systems for local women undergoing a unilateral mastectomy. To our knowledge, no such systems have been evaluated or proven effective as a treatment option among local breast cancer patients with acute disabilities.
METHODS
METHODS
This is a pilot quasi-experimental trial that aims to evaluate the feasibility of tele-rehabilitation and tele-drain care compared to usual care. Up to 40 patients (20 per group) will be recruited for this trial. They will be assigned to an intervention group that receives rehabilitation via a tele-rehabilitation system or a control group that receives rehabilitation in person at their clinic. The primary outcome of this trial is rehabilitation participation (i.e., the time spent on rehabilitation). The secondary outcomes are upper extremity functioning, perceived health, and quality of life.
DISCUSSION
CONCLUSIONS
As part of this pilot trial, patients who opt in for the tele-rehabilitation will be asked to share their experience with and thoughts on the tele-rehabilitation system. With the evidence obtained from the tele-rehabilitation patients of this trial, we will be able to improve the current system for our future trial. Further, our additional data on rehabilitation participation, physical function, and quality of life will help us design a sufficiently powered future main trial.
TRIAL REGISTRATION
BACKGROUND
The trial was approved by the National Healthcare Group's Domain Specific Review Board (#2019/00283) and registered with www.ClinicalTrials.gov (# NCT04269967 ) in February 2020.
Identifiants
pubmed: 33522962
doi: 10.1186/s40814-021-00776-5
pii: 10.1186/s40814-021-00776-5
pmc: PMC7849141
doi:
Banques de données
ClinicalTrials.gov
['NCT04269967']
Types de publication
Journal Article
Langues
eng
Pagination
39Subventions
Organisme : Ministry of Education Tier 1 (Singapore)
ID : FY18
Organisme : Singapore Cancer Society
ID : Research Grant 2018
Références
CA Cancer J Clin. 2016 Jul;66(4):271-89
pubmed: 27253694
Ann Acad Med Singap. 2014 Mar;43(3):136-44
pubmed: 24714707
J Bone Joint Surg Am. 2005 May;87(5):1038-46
pubmed: 15866967
Res Nurs Health. 2008 Apr;31(2):180-91
pubmed: 18183564
Eur J Phys Rehabil Med. 2017 Oct;53(5):633-642
pubmed: 28322035
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Qual Life Res. 2005 May;14(4):1181-6
pubmed: 16041912
BMC Musculoskelet Disord. 2006 May 18;7:44
pubmed: 16709254
Cancer. 2016 Oct 15;122(20):3166-3174
pubmed: 27332968
Rev Bras Epidemiol. 2013 Jun;16(2):352-63
pubmed: 24142007
Lymphat Res Biol. 2005;3(4):208-17
pubmed: 16379589
Breast Cancer Res Treat. 2017 Feb;161(3):443-452
pubmed: 27933450
Arch Phys Med Rehabil. 2014 Mar;95(3):493-8
pubmed: 24095658
PLoS One. 2014 May 09;9(5):e96748
pubmed: 24816774
Pilot Feasibility Stud. 2019 Feb 28;5:37
pubmed: 30858987
Cancer Treat Rev. 2010 Apr;36(2):185-94
pubmed: 19962830
J Med Internet Res. 2014 Dec 18;16(12):e295
pubmed: 25525672
Phys Ther. 1987 Dec;67(12):1867-72
pubmed: 3685114
Springerplus. 2015 Nov 10;4:685
pubmed: 26576328
Ann Surg Oncol. 2009 Oct;16(10):2682-90
pubmed: 19653046
Health Qual Life Outcomes. 2015 Dec 23;13:203
pubmed: 26694964