An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients (EORTC QLQ-BC23) - EORTC QLQ-BR45

Bjelic‐Radisic, Vesna; Bottomley, Andrew; Cardoso, Fátima; Cameron, David; Brain, Étienne; Kuljanić, Karin; Costa, Renata Gomes da; Conroy, Thierry; Inwald, Elisabeth C.; Serpentini, Samantha; Pinto, Monica; Weis, Joachim; Morag, Ofir; Astrup, G.; Tomaszweksi, K.; Pogoda, Katarzyna; Sinai, Parisa; Sprangers, M. A. G.; Aaronson, Neil K.; Greimel, Elfriede

doi:10.1093/annonc/mdy270.267

“…The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 version 3) and Updated Breast Cancer Module (EORTC QLQ-BR45) The EORTC QLQ C-30 is a 30-item instrument measuring HRQoL with five functional scales (physical, role, cognitive, emotional, and social), a global quality of life scale, eight symptom scales or items (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, sleep disturbance, constipation and diarrhea) and a single item assessing perceived financial impact [32]. The EORTC QLQ-BR45 contains five functional scales or items (body image, future perspective, sexual functioning, sexual enjoyment, and breast satisfaction) and seven symptom scales or items (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, and endocrine sexual symptoms) [33]. Scores will be calculated according to EORTC guidelines [34].…”

Section: Secondary Outcome Measuresmentioning

confidence: 99%

“…Higher scores on symptom scales and items indicate higher symptom burden [35]. The measures have strong evidence of validity and reliability in early stage breast cancer patients and have been used in a number of clinical trials allowing for comparisons [33,36].…”

Section: Secondary Outcome Measuresmentioning

confidence: 99%

Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)

Lidington

¹

,

McGrath

²

,

Noble

³

et al. 2020

Trials

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Background: There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. Methods: This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results. Discussion: This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination. Trial registration: The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.

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“…a single item assessing perceived financial impact [32]. The QLQ-BR45 contains five functional scales or items (body image, future perspective, sexual functioning, sexual enjoyment and breast satisfaction) and 7 symptom scales or items (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms and endocrine sexual symptoms) [33]. Scores will be calculated according to EORTC guidelines [34].…”

Section: Measures Primary Outcome Measure Patient Activation Measure mentioning

confidence: 99%

Evaluating a digital tool for supporting breast cancer patients: a randomised controlled trial protocol (ADAPT)

Lidington

¹

,

McGrath

²

,

Noble

³

et al. 2019

Preprint

0

View full text Add to dashboard Cite

Background: There is a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. Methods: This randomised controlled trial with early-stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status and NHS health resource utilisation over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3 months, 6 months and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilisation data from Discover, an integrated care record of primary, secondary and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results. Discussion: This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumour types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate and assess the effects of contamination. Trial registration: The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.

show abstract

“…This 30-item instrument measuring HRQoL has five functional scales (physical, role, cognitive, emotional and social), a global quality of life scale, eight symptom scales or items (fatigue, pain, nausea and vomiting, dyspnoea, loss of appetite, sleep disturbance, constipation and diarrhoea) and a single item assessing perceived financial impact [32]. The QLQ-BR45 contains five functional scales or items (body image, future perspective, sexual functioning, sexual enjoyment and breast satisfaction) and 7 symptom scales or items (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms and endocrine sexual symptoms) [33]. Scores will be calculated according to EORTC guidelines [34].…”

Section: Primary Outcome Measurementioning

confidence: 99%

“…Higher scores on symptom scales and items indicate higher symptom burden [35]. The measures have strong evidence of validity and reliability in early-breast cancer patients and have been used in a number of clinical trials allowing for comparisons [33,36].…”

Section: Primary Outcome Measurementioning

confidence: 99%

Evaluating a digital tool for supporting breast cancer patients: a randomised controlled trial protocol (ADAPT)

Lidington

¹

,

McGrath

²

,

Noble

³

et al. 2019

Preprint

0

View full text Add to dashboard Cite

Background: There is a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. Methods: This randomised controlled trial with early-stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status and NHS health resource utilisation over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3 months, 6 months and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilisation data from Discover, an integrated care record of primary, secondary and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results. Discussion: This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumour types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate and assess the effects of contamination.

show abstract

An international update of the EORTC questionnaire for assessing quality of life in breast cancer patients (EORTC QLQ-BC23) - EORTC QLQ-BR45

Cited by 26 publications

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Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)

Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)

Evaluating a digital tool for supporting breast cancer patients: a randomised controlled trial protocol (ADAPT)

Evaluating a digital tool for supporting breast cancer patients: a randomised controlled trial protocol (ADAPT)

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