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Gepubliceerd in: Quality of Life Research 1/2018

16-12-2017 | Special Section: Measuring What Matters (by invitation only)

Measuring what matters MOST: validation of the Measure of Ovarian Symptoms and Treatment, a patient-reported outcome measure of symptom burden and impact of chemotherapy in recurrent ovarian cancer

Auteurs: Madeleine T. King, Martin R. Stockler, Rachel L. O’Connell, Luke Buizen, Florence Joly, Anne Lanceley, Felix Hilpert, Aikou Okamoto, Eriko Aotani, Jane Bryce, Paul Donnellan, Amit Oza, Elisabeth Avall-Lundqvist, Jonathan S. Berek, Jalid Sehouli, Amanda Feeney, Dominique Berton-Rigaud, Daniel S. J. Costa, Michael L. Friedlander, for the GCIG Symptom Benefit group

Gepubliceerd in: Quality of Life Research | Uitgave 1/2018

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Abstract

Purpose

Gynecologic Cancer Intergroup Symptom Benefit Study (GCIG-SBS) Stage 2 aimed to review, revise, and validate a patient-reported outcome measure (PROM), the Measure of Ovarian Symptoms and Treatment concerns (MOST), developed in GCIG-SBS Stage 1 (MOSTv1, 35 items), and document recurrent ovarian cancer (ROC) symptom burden and benefit.

Methods

GCIG-SBS Stage 2 recruited patients with platinum-resistant/refractory ROC (PRR-ROC) or potentially platinum-sensitive ROC with ≥ 3 lines of prior chemotherapy (PPS-ROC ≥ 3). Patients completed MOSTv1, QLQ-C30, QLQ-OV28, and FACT-O/FOSI at baseline and before cycle 3 of chemotherapy (pre-C3), and global assessments of change (MOST-Change) pre-C3. Clinicians rated patients’ cancer-related symptoms, performance status, and adverse events. Convergent and divergent validity (Spearman’s correlations), discriminative validity (effect sizes between groups classified by clinician-rated characteristics), and responsiveness (paired t tests in patients expected to experience clinically meaningful change) were assessed.

Results

Of 948 recruits, 903 completed PROMs at baseline and 685 pre-C3. Baseline symptom burden was substantial for PRR-ROC and PPS-ROC ≥ 3. MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo), disease or treatment-related symptoms (MOST-DorT), chemotherapy-related symptoms (MOST-Chemo), psychological symptoms (MOST-Psych), and MOST-Well-being. Correlations confirmed concurrent and divergent validity. Discriminative validity was confirmed by effect sizes that conformed with a priori hypotheses. MOST-Abdo was responsive to improvements in abdominal symptoms and MOST-Chemo detected the adverse effects of chemotherapy.

Conclusions

The MOSTv2 validly quantifies patient-reported symptom burden, adverse effects, and symptom benefit in ROC, and as such is fit-for-purpose for clinical trials of palliative chemotherapy in ROC. Further research is required to assess test–retest reliability.
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Literatuur
3.
go back to reference Friedlander, M. L., Mercieca-Bebber, R., & King, M. T. (2016). Patient-reported outcomes (PRO) in ovarian cancer clinical trials—lost opportunities and lessons learned. 27(Suppl 1), i66–i71, doi: 10.​1093/​annonc/​mdw080. Friedlander, M. L., Mercieca-Bebber, R., & King, M. T. (2016). Patient-reported outcomes (PRO) in ovarian cancer clinical trials—lost opportunities and lessons learned. 27(Suppl 1), i66–i71, doi: 10.​1093/​annonc/​mdw080.
4.
go back to reference Wilson, M. K., Pujade-Lauraine, E., Aoki, D., Mirza, M. R., Lorusso, D., Oza, A. M., et al. (2016). 5th Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: Recurrent Disease. Annals of Oncology, 19. Wilson, M. K., Pujade-Lauraine, E., Aoki, D., Mirza, M. R., Lorusso, D., Oza, A. M., et al. (2016). 5th Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: Recurrent Disease. Annals of Oncology, 19.
5.
go back to reference Hanker, L. C., Loibl, S., Burchardi, N., Pfisterer, J., Meier, W., Pujade-Lauraine, E., et al. (2012). The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/platinum-based therapy. Annals of Oncology, 23(10), 2605–2612. CrossRefPubMed Hanker, L. C., Loibl, S., Burchardi, N., Pfisterer, J., Meier, W., Pujade-Lauraine, E., et al. (2012). The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/platinum-based therapy. Annals of Oncology, 23(10), 2605–2612. CrossRefPubMed
6.
go back to reference du Bois, A., Quinn, M., Thigpen, T., Vermorken, J., Avall-Lundqvist, E., Bookman, M., et al. (2005). 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Annals of Oncology, 16, 7–12. doi: 10.​1093/​annonc/​mdi961. CrossRef du Bois, A., Quinn, M., Thigpen, T., Vermorken, J., Avall-Lundqvist, E., Bookman, M., et al. (2005). 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Annals of Oncology, 16, 7–12. doi: 10.​1093/​annonc/​mdi961. CrossRef
7.
go back to reference Cherny, N. I., Sullivan, R., Dafni, U., Kerst, J. M., Sobrero, A., Zielinski, C., et al. (2005). A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Annals of Oncology, 26(8), 1547–1573. CrossRef Cherny, N. I., Sullivan, R., Dafni, U., Kerst, J. M., Sobrero, A., Zielinski, C., et al. (2005). A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Annals of Oncology, 26(8), 1547–1573. CrossRef
8.
go back to reference Schnipper, L. E., Davidson, N. E., Wollins, D. S., Tyne, C., Blayney, D. W., Blum, D., et al. (2005). American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Journal of Clinical Oncology, 33(23), 2563–2577. CrossRef Schnipper, L. E., Davidson, N. E., Wollins, D. S., Tyne, C., Blayney, D. W., Blum, D., et al. (2005). American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options. Journal of Clinical Oncology, 33(23), 2563–2577. CrossRef
9.
go back to reference Friedlander, M. L., Stockler, M., O’Connell, R., Voysey, M., Oza, A., Gillies, K., et al. (2014). Symptom burden and outcomes of patients with platinum resistant/refractory recurrent ovarian cancer: a reality check: results of stage 1 of the gynecologic cancer intergroup symptom benefit study. International Journal of Gynecological Cancer, 24(5), 857–864. doi: 10.​1097/​IGC.​0000000000000147​. CrossRefPubMed Friedlander, M. L., Stockler, M., O’Connell, R., Voysey, M., Oza, A., Gillies, K., et al. (2014). Symptom burden and outcomes of patients with platinum resistant/refractory recurrent ovarian cancer: a reality check: results of stage 1 of the gynecologic cancer intergroup symptom benefit study. International Journal of Gynecological Cancer, 24(5), 857–864. doi: 10.​1097/​IGC.​0000000000000147​. CrossRefPubMed
10.
go back to reference King, M. T., Stockler, M. R., Butow, P., O’Connell, R., Voysey, M., Oza, A. M., et al. (2014). Development of the measure of ovarian symptoms and treatment concerns: aiming for optimal measurement of patient-reported symptom benefit with chemotherapy for symptomatic ovarian cancer. International Journal of Gynecological Cancer, 24(5), 865–873. doi: 10.​1097/​IGC.​0000000000000167​. CrossRefPubMed King, M. T., Stockler, M. R., Butow, P., O’Connell, R., Voysey, M., Oza, A. M., et al. (2014). Development of the measure of ovarian symptoms and treatment concerns: aiming for optimal measurement of patient-reported symptom benefit with chemotherapy for symptomatic ovarian cancer. International Journal of Gynecological Cancer, 24(5), 865–873. doi: 10.​1097/​IGC.​0000000000000167​. CrossRefPubMed
11.
go back to reference FDA (2009). Food and drug administration. guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 74(235), 65132–65133. FDA (2009). Food and drug administration. guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Federal Register, 74(235), 65132–65133.
12.
go back to reference Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. CrossRefPubMed Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. CrossRefPubMed
13.
go back to reference Greimel, E., Bottomley, A., Cull, A., Waldenstrom, A. C., Arraras, J., Chauvenet, L., et al. (2003). An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. European Journal of Cancer (Oxford, England: 1990), 39(10), 1402–1408. CrossRef Greimel, E., Bottomley, A., Cull, A., Waldenstrom, A. C., Arraras, J., Chauvenet, L., et al. (2003). An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. European Journal of Cancer (Oxford, England: 1990), 39(10), 1402–1408. CrossRef
14.
go back to reference Basen-Engquist, K., Bodurka-Bevers, D., Fitzgerald, M. A., Webster, K., Cella, D., Hu, S., et al. (2001). Reliability and validity of the functional assessment of cancer therapy-ovarian. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 19(6), 1809–1817. CrossRef Basen-Engquist, K., Bodurka-Bevers, D., Fitzgerald, M. A., Webster, K., Cella, D., Hu, S., et al. (2001). Reliability and validity of the functional assessment of cancer therapy-ovarian. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 19(6), 1809–1817. CrossRef
15.
go back to reference Beaumont, J., Yount, S., Lalla, D., Lubeck, D., Derynck, M., & Karlan, B. e. a. (2007). Validation of the functional assessment of cancer therapy-Ovarian (FACT-O) symptom index (FOSI) in a phase II clinical trial of pertuzumab in patients with advanced ovarian cancer. ASCO Annual Meeting Proceedings Part I. 25, 18S. Beaumont, J., Yount, S., Lalla, D., Lubeck, D., Derynck, M., & Karlan, B. e. a. (2007). Validation of the functional assessment of cancer therapy-Ovarian (FACT-O) symptom index (FOSI) in a phase II clinical trial of pertuzumab in patients with advanced ovarian cancer. ASCO Annual Meeting Proceedings Part I. 25, 18S.
16.
go back to reference Cella, D., Paul, D., Yount, S., Winn, R., Chang, C. H., Banik, D., et al. (2003). What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN). Cancer Investigation, 21(4), 526–535. CrossRefPubMed Cella, D., Paul, D., Yount, S., Winn, R., Chang, C. H., Banik, D., et al. (2003). What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN). Cancer Investigation, 21(4), 526–535. CrossRefPubMed
18.
go back to reference Sehouli, J., Stengel, D., Harter, P., Kurzeder, C., Belau, A., Bogenrieder, T., et al. (2011). Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer: a randomized multicenter phase II trial of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. Journal of Clinical Oncology, 29(2), 242–248. doi: 10.​1200/​JCO.​2009.​27.​8911. CrossRefPubMed Sehouli, J., Stengel, D., Harter, P., Kurzeder, C., Belau, A., Bogenrieder, T., et al. (2011). Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer: a randomized multicenter phase II trial of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. Journal of Clinical Oncology, 29(2), 242–248. doi: 10.​1200/​JCO.​2009.​27.​8911. CrossRefPubMed
19.
go back to reference Dewolf, L., Koller, M., Velikova, G., Johnson, C., Scott, N., Bottomley, A., et al. (2009). EORTC Quality of Life Group Translation Procedure (3rd edn.). ed.). Brussels: EORTC Publicatiions. Dewolf, L., Koller, M., Velikova, G., Johnson, C., Scott, N., Bottomley, A., et al. (2009). EORTC Quality of Life Group Translation Procedure (3rd edn.). ed.). Brussels: EORTC Publicatiions.
20.
23.
go back to reference Fayers, P. M., & Hand, D. J. (2002). Causal variables, indicator variables and measurement scales: An example from quality of life. Journal of Royal Statistics Society A, 165(2), 233–261. CrossRef Fayers, P. M., & Hand, D. J. (2002). Causal variables, indicator variables and measurement scales: An example from quality of life. Journal of Royal Statistics Society A, 165(2), 233–261. CrossRef
24.
go back to reference Streiner, D. L. (2003). Being inconsistent about consistency: when coefficient alpha does and doesn’t matter. Journal of Personality Assessment, 80(3), 217–222. CrossRefPubMed Streiner, D. L. (2003). Being inconsistent about consistency: when coefficient alpha does and doesn’t matter. Journal of Personality Assessment, 80(3), 217–222. CrossRefPubMed
25.
go back to reference Cohen, J. (1988). Statistical power analysis for the behavioral sciences, Abington: Routledge. Cohen, J. (1988). Statistical power analysis for the behavioral sciences, Abington: Routledge.
26.
go back to reference Campbell, D. T., & Fiske, D. W. (1959). Convergent and discriminant validation by the multitrait-multimethod matrix. Psychological Bulletin, 56(2), 81–105. CrossRefPubMed Campbell, D. T., & Fiske, D. W. (1959). Convergent and discriminant validation by the multitrait-multimethod matrix. Psychological Bulletin, 56(2), 81–105. CrossRefPubMed
27.
go back to reference Cocks, K., King, M. T., Velikova, G., St-James, Martyn, Fayers, M., P. M., & Brown, J. M. (2011). Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology, 29(1), 89–96. doi: 10.​1200/​JCO.​2010.​28.​0107. CrossRefPubMed Cocks, K., King, M. T., Velikova, G., St-James, Martyn, Fayers, M., P. M., & Brown, J. M. (2011). Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology, 29(1), 89–96. doi: 10.​1200/​JCO.​2010.​28.​0107. CrossRefPubMed
28.
go back to reference King, M. T. (1996). The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Quality of Life Research, 5(6), 555–567. CrossRefPubMed King, M. T. (1996). The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Quality of Life Research, 5(6), 555–567. CrossRefPubMed
31.
go back to reference Stuart, G. C., Kitchener, H., Bacon, M., duBois, A., Friedlander, M., Ledermann, J., et al. (2011). 2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference. International Journal of Gynecological Cancer, 21(4), 750–755. CrossRefPubMed Stuart, G. C., Kitchener, H., Bacon, M., duBois, A., Friedlander, M., Ledermann, J., et al. (2011). 2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference. International Journal of Gynecological Cancer, 21(4), 750–755. CrossRefPubMed
Metagegevens
Titel
Measuring what matters MOST: validation of the Measure of Ovarian Symptoms and Treatment, a patient-reported outcome measure of symptom burden and impact of chemotherapy in recurrent ovarian cancer
Auteurs
Madeleine T. King
Martin R. Stockler
Rachel L. O’Connell
Luke Buizen
Florence Joly
Anne Lanceley
Felix Hilpert
Aikou Okamoto
Eriko Aotani
Jane Bryce
Paul Donnellan
Amit Oza
Elisabeth Avall-Lundqvist
Jonathan S. Berek
Jalid Sehouli
Amanda Feeney
Dominique Berton-Rigaud
Daniel S. J. Costa
Michael L. Friedlander
for the GCIG Symptom Benefit group
Publicatiedatum
16-12-2017
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 1/2018
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-017-1729-8

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