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A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial
BACKGROUND: The-Optimal-Lymph-Flow (TOLF) is a patient-centered, web- and mobile-based mHealth system that delivers safe, easy, and feasible digital therapy of lymphatic exercises and limb mobility exercises. OBJECTIVE: The purpose of this randomized clinical trial (RCT) was to evaluate the effectiv...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8893593/ https://www.ncbi.nlm.nih.gov/pubmed/35037883 http://dx.doi.org/10.2196/29485 |
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author | Fu, Mei Rosemary Axelrod, Deborah Guth, Amber A Scagliola, Joan Rampertaap, Kavita El-Shammaa, Nardin Qiu, Jeanna M McTernan, Melissa L Frye, Laura Park, Christopher S Yu, Gary Tilley, Charles Wang, Yao |
author_facet | Fu, Mei Rosemary Axelrod, Deborah Guth, Amber A Scagliola, Joan Rampertaap, Kavita El-Shammaa, Nardin Qiu, Jeanna M McTernan, Melissa L Frye, Laura Park, Christopher S Yu, Gary Tilley, Charles Wang, Yao |
author_sort | Fu, Mei Rosemary |
collection | PubMed |
description | BACKGROUND: The-Optimal-Lymph-Flow (TOLF) is a patient-centered, web- and mobile-based mHealth system that delivers safe, easy, and feasible digital therapy of lymphatic exercises and limb mobility exercises. OBJECTIVE: The purpose of this randomized clinical trial (RCT) was to evaluate the effectiveness of the web- and mobile-based TOLF system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference measured by infrared perometer, BMI, and quality of life (QOL) related to pain. We hypothesized that participants in the intervention group would have improved pain and symptom experiences, limb volume difference, BMI, and QOL. METHODS: A parallel RCT with a control–experimental, pre- and posttest, and repeated-measures design were used. A total of 120 patients were recruited face-to-face at the point of care during clinical visits. Patients were randomized according to pain in a 1:1 ratio into either the arm precaution (AP) control group to improve limb mobility and arm protection or The-Optimal-Lymph flow (TOLF) intervention group to promote lymph flow and limb mobility. Trial outcomes were evaluated at baseline and at week 12 after the intervention. Descriptive statistics, Fisher exact tests, Wilcoxon rank-sum tests, t test, and generalized linear mixed effects models were performed for data analysis. RESULTS: At the study endpoint of 12 weeks, significantly fewer patients in the TOLF intervention group compared with the AP control group reported chronic pain (45% [27/60] vs 70% [42/60]; odds ratio [OR] 0.39, 95% CI 0.17-0.90; P=.02). Patients who received the TOLF intervention were significantly more likely to achieve a complete reduction in pain (50% [23/46] vs 22% [11/51]; OR 3.56, 95% CI 1.39-9.76; P=.005) and soreness (43% [21/49] vs 22% [11/51]; OR 2.60, 95% CI 1.03-6.81; P=.03). Significantly lower median severity scores were found in the TOLF group for chronic pain (MedTOLF=0, IQR 0-1 vs MedAP=1, IQR 0-2; P=.02) and general bodily pain (MedTOLF=1, IQR=0-1.5 vs MedAP=1, IQR 1-3; P=.04). Compared with the AP control group, significantly fewer patients in the TOLF group reported arm/hand swelling (P=.04), heaviness (P=.03), redness (P=.03), and limited movement in shoulder (P=.02) and arm (P=.03). No significant differences between the TOLF and AP groups were found in complete reduction of aching (P=.12) and tenderness (P=.65), mean numbers of lymphedema symptom reported (P=.11), ≥5% limb volume differences (P=.48), and BMI (P=.12). CONCLUSIONS: The TOLF intervention had significant benefits for breast cancer survivors to manage chronic pain, soreness, general bodily pain, arm/hand swelling, heaviness, and impaired limb mobility. The intervention resulted in a 13% reduction (from 40% [24/60] to 27% [16/60]) in proportions of patients who took pain medications compared with the AP control group, which had a 5% increase (from 40% [24/60] to 45% [27/60]). A 12% reduction (from 27% [16/60] to 15% [9/60]) in proportions of patients with ≥5% limb volume differences was found in the TOLF intervention, while a 5% increase in the AP control group (from 40% [24/60] to 45% [27/60]) was found. In conclusion, the TOLF intervention can be a better choice for breast cancer survivors to reduce chronic pain and limb volume. TRIAL REGISTRATION: Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.5104 |
format | Online Article Text |
id | pubmed-8893593 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-88935932022-03-10 A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial Fu, Mei Rosemary Axelrod, Deborah Guth, Amber A Scagliola, Joan Rampertaap, Kavita El-Shammaa, Nardin Qiu, Jeanna M McTernan, Melissa L Frye, Laura Park, Christopher S Yu, Gary Tilley, Charles Wang, Yao JMIR Cancer Original Paper BACKGROUND: The-Optimal-Lymph-Flow (TOLF) is a patient-centered, web- and mobile-based mHealth system that delivers safe, easy, and feasible digital therapy of lymphatic exercises and limb mobility exercises. OBJECTIVE: The purpose of this randomized clinical trial (RCT) was to evaluate the effectiveness of the web- and mobile-based TOLF system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference measured by infrared perometer, BMI, and quality of life (QOL) related to pain. We hypothesized that participants in the intervention group would have improved pain and symptom experiences, limb volume difference, BMI, and QOL. METHODS: A parallel RCT with a control–experimental, pre- and posttest, and repeated-measures design were used. A total of 120 patients were recruited face-to-face at the point of care during clinical visits. Patients were randomized according to pain in a 1:1 ratio into either the arm precaution (AP) control group to improve limb mobility and arm protection or The-Optimal-Lymph flow (TOLF) intervention group to promote lymph flow and limb mobility. Trial outcomes were evaluated at baseline and at week 12 after the intervention. Descriptive statistics, Fisher exact tests, Wilcoxon rank-sum tests, t test, and generalized linear mixed effects models were performed for data analysis. RESULTS: At the study endpoint of 12 weeks, significantly fewer patients in the TOLF intervention group compared with the AP control group reported chronic pain (45% [27/60] vs 70% [42/60]; odds ratio [OR] 0.39, 95% CI 0.17-0.90; P=.02). Patients who received the TOLF intervention were significantly more likely to achieve a complete reduction in pain (50% [23/46] vs 22% [11/51]; OR 3.56, 95% CI 1.39-9.76; P=.005) and soreness (43% [21/49] vs 22% [11/51]; OR 2.60, 95% CI 1.03-6.81; P=.03). Significantly lower median severity scores were found in the TOLF group for chronic pain (MedTOLF=0, IQR 0-1 vs MedAP=1, IQR 0-2; P=.02) and general bodily pain (MedTOLF=1, IQR=0-1.5 vs MedAP=1, IQR 1-3; P=.04). Compared with the AP control group, significantly fewer patients in the TOLF group reported arm/hand swelling (P=.04), heaviness (P=.03), redness (P=.03), and limited movement in shoulder (P=.02) and arm (P=.03). No significant differences between the TOLF and AP groups were found in complete reduction of aching (P=.12) and tenderness (P=.65), mean numbers of lymphedema symptom reported (P=.11), ≥5% limb volume differences (P=.48), and BMI (P=.12). CONCLUSIONS: The TOLF intervention had significant benefits for breast cancer survivors to manage chronic pain, soreness, general bodily pain, arm/hand swelling, heaviness, and impaired limb mobility. The intervention resulted in a 13% reduction (from 40% [24/60] to 27% [16/60]) in proportions of patients who took pain medications compared with the AP control group, which had a 5% increase (from 40% [24/60] to 45% [27/60]). A 12% reduction (from 27% [16/60] to 15% [9/60]) in proportions of patients with ≥5% limb volume differences was found in the TOLF intervention, while a 5% increase in the AP control group (from 40% [24/60] to 45% [27/60]) was found. In conclusion, the TOLF intervention can be a better choice for breast cancer survivors to reduce chronic pain and limb volume. TRIAL REGISTRATION: Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.5104 JMIR Publications 2022-01-17 /pmc/articles/PMC8893593/ /pubmed/35037883 http://dx.doi.org/10.2196/29485 Text en ©Mei Rosemary Fu, Deborah Axelrod, Amber A Guth, Joan Scagliola, Kavita Rampertaap, Nardin El-Shammaa, Jeanna M Qiu, Melissa L McTernan, Laura Frye, Christopher S Park, Gary Yu, Charles Tilley, Yao Wang. Originally published in JMIR Cancer (https://cancer.jmir.org), 17.01.2022. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Cancer, is properly cited. The complete bibliographic information, a link to the original publication on https://cancer.jmir.org/, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Fu, Mei Rosemary Axelrod, Deborah Guth, Amber A Scagliola, Joan Rampertaap, Kavita El-Shammaa, Nardin Qiu, Jeanna M McTernan, Melissa L Frye, Laura Park, Christopher S Yu, Gary Tilley, Charles Wang, Yao A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial |
title | A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial |
title_full | A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial |
title_fullStr | A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial |
title_full_unstemmed | A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial |
title_short | A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial |
title_sort | web- and mobile-based intervention for women treated for breast cancer to manage chronic pain and symptoms related to lymphedema: results of a randomized clinical trial |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8893593/ https://www.ncbi.nlm.nih.gov/pubmed/35037883 http://dx.doi.org/10.2196/29485 |
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