Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Study Group Investigators:; Elizabeth A. Hahn; Stephanie L. Pugh; Hien L. Lu; Alyssa M. Vela; Erin F. Gillespie; Elizabeth M. Nichols; Jean L. Wright; Shannon M. MacDonald; Oren Cahlon; Carole Baas; Lior Z. Braunstein; L. Christine Fang; Gary M. Freedman; Rachel B. Jimenez; Christy M. Kesslering; Mark V. Mishra; Robert W. Mutter; Nisha Ohri; Lane R. Rosen; James J. Urbanic; Reshma Jagsi; Sandra A. Mitchell; Justin E. Bekelman; David Cella; Karen D. Godette; Sagar Patel; Katja M. Langen; Ryan R. Zielan; David DeBlois; Dalong Pang; Sonali Rudra; Sidi Benhabib; Ashish Chawla; Kuanling Chen; Hossein Dadkhah; Lonika Majithia; Avani D. Rao; Lisa Stephenson; Peng Wang; Victoria J. Croog; Heng Li; Karen Smith; Susan Stinson; Amanda J. Walker; Kiran Devisetty; Christian Hyde; Nicholas Depauw; Anuradha Godishala; Alice Ho; Harald Paganetti; Daniel Soto; Giselle Suero-Abreu; Alphonse G. Taghian; Kimberly S. Corbin; Michele Y. Halyard; Amanda Jackson; Xiaoying Liang; Heather Manke; Lisa A. McGee; Deanna H. Pafundi; Nicholas B. Remmes; Dean A. Shumway; Elizabeth S. Yan; Samuel F. Bakhoum; David A. Barron; Michael Bernstein; John J. Cuaron; Laura Dover; Daphna Y. Gelblum; Philip Gilbo; Richard M. Gewanter; David M. Guttman; Linda Hong; Atif Khan; Quincey LaPlant; Justin Mann; Beryl McCormick; Boris A. Mueller; Borys Mychalczak; Dhwani Parikh; Simon N. Powell; Paul B. Romesser; Diana Roth O'Brien; Karen D. Schupak; Annemarie F. Shepherd; Amy Xu; Anthony Yu; Melissa Zinovoy; Jaafar Bennouna; Marcio Fagundes; Joseph Panoff; Maria Amelia Rodrigues; Jen Yu; Choonsik Lee; Chin Cheng Chen; J. Isabelle Choi; Haibo Lin; Adil S. Akthar; Nausheen Akhter; Stephen A. Mihalcik; Mark Pankuch; Preeti K. Parhar; Michael D. Stutz; Arpi D. Thukral; Dennis Mah; Henry K. Tsai; Rebecca Paulus; Bruce G. Haffty; Sharad Goyal; Ning J. Yue; Jared D. Sturgeon; J. Ben Wilkinson; D. Hunter Boggs; Rex A. Cardan; Allison Dalton; Andrew McDonald; Fred Prior; Jyoti S. Mayadev; Vitali Moiseenko; Anya Narezkina; Nicholas Phreaner; Dominique Rash; Tyler Seibert; Catheryn Yashar; Emily C. Daugherty; Anthony Mascia; Sara A. Medek; Teresa Meier; Julie A. Bradley; Natalie Lockney; Raymond B. Mailhot; Nancy Mendenhall; Michael Rutenberg; Eleanor E. Harris; Janice Lyons; Jack J. Hong; Dan K. Kunaprayoon; Sarah A. McAvoy; Mysore Manu Mysore; Kamila A. Nowak Choi; Akshar N. Patel; Melissa A.L. Vyfhuis; Joelle Wilson; Ozer Algan; Yong Chen; Christina E. Henson; Tomas Dvorak; Twyla Willoughby; Omar Zeidan; Abigail T. Berman; Et tsu Chen; Lei Dong; Amanda Driscoll; Steven J. Feigenberg; Ashley Feriozzi; Carolyn Hencek; James D. Kolker; Andre A. Konski; Bonnie Ky; Lilie L. Lin; Kristina L. Novick; Nosheen Reza; Ann Marie Siegal; Sara Tabakha; Neil K. Taunk; Nicholas Wilcox; Wei Zou; Neha Bhooshan; Richard Croley; David C. Weksberg; Neelour Ahmad; Karen E. Hoffman; Melissa M. Joyner; Melissa P. Mitchell; Falk Poenisch; Benjamin D. Smith; Eric A. Strom; Srilakshmi Vallabhaneni; Richard Cheng; Kylie H. Kang; H. Katherine Kim; Janice N. Kim; Waylene A. Wang; Tony Wong; Walter Bosch; Joshua Mitchell; William Straube; Imran Zoberi; Dinu Balanescu; Peter Y. Chen; Joshua T. Dilworth; Xuanfeng Ding; Teodora Donisan; Daniel A. Hamstra; Phuong Daniella Dang; Stanford Katz; Chiachien J. Wang; Wu Terry Wu

doi:10.1016/j.ijrobp.2024.03.020

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

Study Group Investigators:, Elizabeth A. Hahn, Stephanie L. Pugh, Hien L. Lu, Alyssa M. Vela, Erin F. Gillespie, Elizabeth M. Nichols, Jean L. Wright, Shannon M. MacDonald, Oren Cahlon, Carole Baas, Lior Z. Braunstein, L. Christine Fang, Gary M. Freedman, Rachel B. Jimenez, Christy M. Kesslering, Mark V. Mishra, Robert W. Mutter, Nisha Ohri, Lane R. RosenJames J. Urbanic, Reshma Jagsi, Sandra A. Mitchell, Justin E. Bekelman, David Cella, Karen D. Godette, Sagar Patel, Katja M. Langen, Ryan R. Zielan, David DeBlois, Dalong Pang, Sonali Rudra, Sidi Benhabib, Ashish Chawla, Kuanling Chen, Hossein Dadkhah, Lonika Majithia, Avani D. Rao, Lisa Stephenson, Peng Wang, Victoria J. Croog, Heng Li, Karen Smith, Susan Stinson, Amanda J. Walker, Kiran Devisetty, Christian Hyde, Nicholas Depauw, Anuradha Godishala, Alice Ho, Harald Paganetti, Daniel Soto, Giselle Suero-Abreu, Alphonse G. Taghian, Kimberly S. Corbin, Michele Y. Halyard, Amanda Jackson, Xiaoying Liang, Heather Manke, Lisa A. McGee, Deanna H. Pafundi, Nicholas B. Remmes, Dean A. Shumway, Elizabeth S. Yan, Samuel F. Bakhoum, David A. Barron, Michael Bernstein, John J. Cuaron, Laura Dover, Daphna Y. Gelblum, Philip Gilbo, Richard M. Gewanter, David M. Guttman, Linda Hong, Atif Khan, Quincey LaPlant, Justin Mann, Beryl McCormick, Boris A. Mueller, Borys Mychalczak, Dhwani Parikh, Simon N. Powell, Paul B. Romesser, Diana Roth O'Brien, Karen D. Schupak, Annemarie F. Shepherd, Amy Xu, Anthony Yu, Melissa Zinovoy, Jaafar Bennouna, Marcio Fagundes, Joseph Panoff, Maria Amelia Rodrigues, Jen Yu, Choonsik Lee, Chin Cheng Chen, J. Isabelle Choi, Haibo Lin, Adil S. Akthar, Nausheen Akhter, Stephen A. Mihalcik, Mark Pankuch, Preeti K. Parhar, Michael D. Stutz, Arpi D. Thukral, Dennis Mah, Henry K. Tsai, Rebecca Paulus, Bruce G. Haffty, Sharad Goyal, Ning J. Yue, Jared D. Sturgeon, J. Ben Wilkinson, D. Hunter Boggs, Rex A. Cardan, Allison Dalton, Andrew McDonald, Fred Prior, Jyoti S. Mayadev, Vitali Moiseenko, Anya Narezkina, Nicholas Phreaner, Dominique Rash, Tyler Seibert, Catheryn Yashar, Emily C. Daugherty, Anthony Mascia, Sara A. Medek, Teresa Meier, Julie A. Bradley, Natalie Lockney, Raymond B. Mailhot, Nancy Mendenhall, Michael Rutenberg, Eleanor E. Harris, Janice Lyons, Jack J. Hong, Dan K. Kunaprayoon, Sarah A. McAvoy, Mysore Manu Mysore, Kamila A. Nowak Choi, Akshar N. Patel, Melissa A.L. Vyfhuis, Joelle Wilson, Ozer Algan, Yong Chen, Christina E. Henson, Tomas Dvorak, Twyla Willoughby, Omar Zeidan, Abigail T. Berman, Et tsu Chen, Lei Dong, Amanda Driscoll, Steven J. Feigenberg, Ashley Feriozzi, Carolyn Hencek, James D. Kolker, Andre A. Konski, Bonnie Ky, Lilie L. Lin, Kristina L. Novick, Nosheen Reza, Ann Marie Siegal, Sara Tabakha, Neil K. Taunk, Nicholas Wilcox, Wei Zou, Neha Bhooshan, Richard Croley, David C. Weksberg, Neelour Ahmad, Karen E. Hoffman, Melissa M. Joyner, Melissa P. Mitchell, Falk Poenisch, Benjamin D. Smith, Eric A. Strom, Srilakshmi Vallabhaneni, Richard Cheng, Kylie H. Kang, H. Katherine Kim, Janice N. Kim, Waylene A. Wang, Tony Wong, Walter Bosch, Joshua Mitchell, William Straube, Imran Zoberi, Dinu Balanescu, Peter Y. Chen, Joshua T. Dilworth, Xuanfeng Ding, Teodora Donisan, Daniel A. Hamstra, Phuong Daniella Dang, Stanford Katz, Chiachien J. Wang, Wu Terry Wu

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Purpose: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). Methods and Materials: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Results: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction – General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. Conclusions: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

Original language	English
Pages (from-to)	149-161
Number of pages	13
Journal	International Journal of Radiation Oncology Biology Physics
Volume	120
Issue number	1
DOIs	https://doi.org/10.1016/j.ijrobp.2024.03.020
State	Published - Sep 1 2024

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10.1016/j.ijrobp.2024.03.020

Cite this

Study Group Investigators:, Hahn, E. A., Pugh, S. L., Lu, H. L., Vela, A. M., Gillespie, E. F., Nichols, E. M., Wright, J. L., MacDonald, S. M., Cahlon, O., Baas, C., Braunstein, L. Z., Fang, L. C., Freedman, G. M., Jimenez, R. B., Kesslering, C. M., Mishra, M. V., Mutter, R. W., Ohri, N., ... Terry Wu, W. (2024). Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial. International Journal of Radiation Oncology Biology Physics, 120(1), 149-161. https://doi.org/10.1016/j.ijrobp.2024.03.020

@article{311b331699064aa29e9a423a8f0488ca,

title = "Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial",

abstract = "Purpose: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). Methods and Materials: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Results: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction – General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. Conclusions: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.",

author = "{Study Group Investigators:} and Hahn, {Elizabeth A.} and Pugh, {Stephanie L.} and Lu, {Hien L.} and Vela, {Alyssa M.} and Gillespie, {Erin F.} and Nichols, {Elizabeth M.} and Wright, {Jean L.} and MacDonald, {Shannon M.} and Oren Cahlon and Carole Baas and Braunstein, {Lior Z.} and Fang, {L. Christine} and Freedman, {Gary M.} and Jimenez, {Rachel B.} and Kesslering, {Christy M.} and Mishra, {Mark V.} and Mutter, {Robert W.} and Nisha Ohri and Rosen, {Lane R.} and Urbanic, {James J.} and Reshma Jagsi and Mitchell, {Sandra A.} and Bekelman, {Justin E.} and David Cella and Godette, {Karen D.} and Sagar Patel and Langen, {Katja M.} and Zielan, {Ryan R.} and David DeBlois and Dalong Pang and Sonali Rudra and Sidi Benhabib and Ashish Chawla and Kuanling Chen and Hossein Dadkhah and Lonika Majithia and Rao, {Avani D.} and Lisa Stephenson and Peng Wang and Croog, {Victoria J.} and Heng Li and Karen Smith and Susan Stinson and Walker, {Amanda J.} and Kiran Devisetty and Christian Hyde and Nicholas Depauw and Anuradha Godishala and Alice Ho and Harald Paganetti and Daniel Soto and Giselle Suero-Abreu and Taghian, {Alphonse G.} and Corbin, {Kimberly S.} and Halyard, {Michele Y.} and Amanda Jackson and Xiaoying Liang and Heather Manke and McGee, {Lisa A.} and Pafundi, {Deanna H.} and Remmes, {Nicholas B.} and Shumway, {Dean A.} and Yan, {Elizabeth S.} and Bakhoum, {Samuel F.} and Barron, {David A.} and Michael Bernstein and Cuaron, {John J.} and Laura Dover and Gelblum, {Daphna Y.} and Philip Gilbo and Gewanter, {Richard M.} and Guttman, {David M.} and Linda Hong and Atif Khan and Quincey LaPlant and Justin Mann and Beryl McCormick and Mueller, {Boris A.} and Borys Mychalczak and Dhwani Parikh and Powell, {Simon N.} and Romesser, {Paul B.} and {Roth O'Brien}, Diana and Schupak, {Karen D.} and Shepherd, {Annemarie F.} and Amy Xu and Anthony Yu and Melissa Zinovoy and Jaafar Bennouna and Marcio Fagundes and Joseph Panoff and {Amelia Rodrigues}, Maria and Jen Yu and Choonsik Lee and Chen, {Chin Cheng} and Choi, {J. Isabelle} and Haibo Lin and Akthar, {Adil S.} and Nausheen Akhter and Mihalcik, {Stephen A.} and Mark Pankuch and Parhar, {Preeti K.} and Stutz, {Michael D.} and Thukral, {Arpi D.} and Dennis Mah and Tsai, {Henry K.} and Rebecca Paulus and Haffty, {Bruce G.} and Sharad Goyal and Yue, {Ning J.} and Sturgeon, {Jared D.} and Wilkinson, {J. Ben} and Boggs, {D. Hunter} and Cardan, {Rex A.} and Allison Dalton and Andrew McDonald and Fred Prior and Mayadev, {Jyoti S.} and Vitali Moiseenko and Anya Narezkina and Nicholas Phreaner and Dominique Rash and Tyler Seibert and Catheryn Yashar and Daugherty, {Emily C.} and Anthony Mascia and Medek, {Sara A.} and Teresa Meier and Bradley, {Julie A.} and Natalie Lockney and Mailhot, {Raymond B.} and Nancy Mendenhall and Michael Rutenberg and Harris, {Eleanor E.} and Janice Lyons and Hong, {Jack J.} and Kunaprayoon, {Dan K.} and McAvoy, {Sarah A.} and {Manu Mysore}, Mysore and {Nowak Choi}, {Kamila A.} and Patel, {Akshar N.} and Vyfhuis, {Melissa A.L.} and Joelle Wilson and Ozer Algan and Yong Chen and Henson, {Christina E.} and Tomas Dvorak and Twyla Willoughby and Omar Zeidan and Berman, {Abigail T.} and Chen, {Et tsu} and Lei Dong and Amanda Driscoll and Feigenberg, {Steven J.} and Ashley Feriozzi and Carolyn Hencek and Kolker, {James D.} and Konski, {Andre A.} and Bonnie Ky and Lin, {Lilie L.} and Novick, {Kristina L.} and Nosheen Reza and Siegal, {Ann Marie} and Sara Tabakha and Taunk, {Neil K.} and Nicholas Wilcox and Wei Zou and Neha Bhooshan and Richard Croley and Weksberg, {David C.} and Neelour Ahmad and Hoffman, {Karen E.} and Joyner, {Melissa M.} and Mitchell, {Melissa P.} and Falk Poenisch and Smith, {Benjamin D.} and Strom, {Eric A.} and Srilakshmi Vallabhaneni and Richard Cheng and Kang, {Kylie H.} and Kim, {H. Katherine} and Kim, {Janice N.} and Wang, {Waylene A.} and Tony Wong and Walter Bosch and Joshua Mitchell and William Straube and Imran Zoberi and Dinu Balanescu and Chen, {Peter Y.} and Dilworth, {Joshua T.} and Xuanfeng Ding and Teodora Donisan and Hamstra, {Daniel A.} and {Daniella Dang}, Phuong and Stanford Katz and Wang, {Chiachien J.} and {Terry Wu}, Wu",

note = "Publisher Copyright: {\textcopyright} 2024 The Authors",

year = "2024",

month = sep,

day = "1",

doi = "10.1016/j.ijrobp.2024.03.020",

language = "English",

volume = "120",

pages = "149--161",

journal = "International Journal of Radiation Oncology Biology Physics",

issn = "0360-3016",

number = "1",

}

Study Group Investigators:, Hahn, EA, Pugh, SL, Lu, HL, Vela, AM, Gillespie, EF, Nichols, EM, Wright, JL, MacDonald, SM, Cahlon, O, Baas, C, Braunstein, LZ, Fang, LC, Freedman, GM, Jimenez, RB, Kesslering, CM, Mishra, MV, Mutter, RW, Ohri, N, Rosen, LR, Urbanic, JJ, Jagsi, R, Mitchell, SA, Bekelman, JE, Cella, D, Godette, KD, Patel, S, Langen, KM, Zielan, RR, DeBlois, D, Pang, D, Rudra, S, Benhabib, S, Chawla, A, Chen, K, Dadkhah, H, Majithia, L, Rao, AD, Stephenson, L, Wang, P, Croog, VJ, Li, H, Smith, K, Stinson, S, Walker, AJ, Devisetty, K, Hyde, C, Depauw, N, Godishala, A, Ho, A, Paganetti, H, Soto, D, Suero-Abreu, G, Taghian, AG, Corbin, KS, Halyard, MY, Jackson, A, Liang, X, Manke, H, McGee, LA, Pafundi, DH, Remmes, NB, Shumway, DA, Yan, ES, Bakhoum, SF, Barron, DA, Bernstein, M, Cuaron, JJ, Dover, L, Gelblum, DY, Gilbo, P, Gewanter, RM, Guttman, DM, Hong, L, Khan, A, LaPlant, Q, Mann, J, McCormick, B, Mueller, BA, Mychalczak, B, Parikh, D, Powell, SN, Romesser, PB, Roth O'Brien, D, Schupak, KD, Shepherd, AF, Xu, A, Yu, A, Zinovoy, M, Bennouna, J, Fagundes, M, Panoff, J, Amelia Rodrigues, M, Yu, J, Lee, C, Chen, CC, Choi, JI, Lin, H, Akthar, AS, Akhter, N, Mihalcik, SA, Pankuch, M, Parhar, PK, Stutz, MD, Thukral, AD, Mah, D, Tsai, HK, Paulus, R, Haffty, BG, Goyal, S, Yue, NJ, Sturgeon, JD, Wilkinson, JB, Boggs, DH, Cardan, RA, Dalton, A, McDonald, A, Prior, F, Mayadev, JS, Moiseenko, V, Narezkina, A, Phreaner, N, Rash, D, Seibert, T, Yashar, C, Daugherty, EC, Mascia, A, Medek, SA, Meier, T, Bradley, JA, Lockney, N, Mailhot, RB, Mendenhall, N, Rutenberg, M, Harris, EE, Lyons, J, Hong, JJ, Kunaprayoon, DK, McAvoy, SA, Manu Mysore, M, Nowak Choi, KA, Patel, AN, Vyfhuis, MAL, Wilson, J, Algan, O, Chen, Y, Henson, CE, Dvorak, T, Willoughby, T, Zeidan, O, Berman, AT, Chen, ET, Dong, L, Driscoll, A, Feigenberg, SJ, Feriozzi, A, Hencek, C, Kolker, JD, Konski, AA, Ky, B, Lin, LL, Novick, KL, Reza, N, Siegal, AM, Tabakha, S, Taunk, NK, Wilcox, N, Zou, W, Bhooshan, N, Croley, R, Weksberg, DC, Ahmad, N, Hoffman, KE, Joyner, MM, Mitchell, MP, Poenisch, F, Smith, BD, Strom, EA, Vallabhaneni, S, Cheng, R, Kang, KH, Kim, HK, Kim, JN, Wang, WA, Wong, T, Bosch, W, Mitchell, J, Straube, W , Zoberi, I, Balanescu, D, Chen, PY, Dilworth, JT, Ding, X, Donisan, T, Hamstra, DA, Daniella Dang, P, Katz, S, Wang, CJ & Terry Wu, W 2024, 'Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial', International Journal of Radiation Oncology Biology Physics, vol. 120, no. 1, pp. 149-161. https://doi.org/10.1016/j.ijrobp.2024.03.020

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial. / Study Group Investigators:; Hahn, Elizabeth A.; Pugh, Stephanie L. et al.
In: International Journal of Radiation Oncology Biology Physics, Vol. 120, No. 1, 01.09.2024, p. 149-161.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

AU - Study Group Investigators:

AU - Hahn, Elizabeth A.

AU - Pugh, Stephanie L.

AU - Lu, Hien L.

AU - Vela, Alyssa M.

AU - Gillespie, Erin F.

AU - Nichols, Elizabeth M.

AU - Wright, Jean L.

AU - MacDonald, Shannon M.

AU - Cahlon, Oren

AU - Baas, Carole

AU - Braunstein, Lior Z.

AU - Fang, L. Christine

AU - Freedman, Gary M.

AU - Jimenez, Rachel B.

AU - Kesslering, Christy M.

AU - Mishra, Mark V.

AU - Mutter, Robert W.

AU - Ohri, Nisha

AU - Rosen, Lane R.

AU - Urbanic, James J.

AU - Jagsi, Reshma

AU - Mitchell, Sandra A.

AU - Bekelman, Justin E.

AU - Cella, David

AU - Godette, Karen D.

AU - Patel, Sagar

AU - Langen, Katja M.

AU - Zielan, Ryan R.

AU - DeBlois, David

AU - Pang, Dalong

AU - Rudra, Sonali

AU - Benhabib, Sidi

AU - Chawla, Ashish

AU - Chen, Kuanling

AU - Dadkhah, Hossein

AU - Majithia, Lonika

AU - Rao, Avani D.

AU - Stephenson, Lisa

AU - Wang, Peng

AU - Croog, Victoria J.

AU - Li, Heng

AU - Smith, Karen

AU - Stinson, Susan

AU - Walker, Amanda J.

AU - Devisetty, Kiran

AU - Hyde, Christian

AU - Depauw, Nicholas

AU - Godishala, Anuradha

AU - Ho, Alice

AU - Paganetti, Harald

AU - Soto, Daniel

AU - Suero-Abreu, Giselle

AU - Taghian, Alphonse G.

AU - Corbin, Kimberly S.

AU - Halyard, Michele Y.

AU - Jackson, Amanda

AU - Liang, Xiaoying

AU - Manke, Heather

AU - McGee, Lisa A.

AU - Pafundi, Deanna H.

AU - Remmes, Nicholas B.

AU - Shumway, Dean A.

AU - Yan, Elizabeth S.

AU - Bakhoum, Samuel F.

AU - Barron, David A.

AU - Bernstein, Michael

AU - Cuaron, John J.

AU - Dover, Laura

AU - Gelblum, Daphna Y.

AU - Gilbo, Philip

AU - Gewanter, Richard M.

AU - Guttman, David M.

AU - Hong, Linda

AU - Khan, Atif

AU - LaPlant, Quincey

AU - Mann, Justin

AU - McCormick, Beryl

AU - Mueller, Boris A.

AU - Mychalczak, Borys

AU - Parikh, Dhwani

AU - Powell, Simon N.

AU - Romesser, Paul B.

AU - Roth O'Brien, Diana

AU - Schupak, Karen D.

AU - Shepherd, Annemarie F.

AU - Xu, Amy

AU - Yu, Anthony

AU - Zinovoy, Melissa

AU - Bennouna, Jaafar

AU - Fagundes, Marcio

AU - Panoff, Joseph

AU - Amelia Rodrigues, Maria

AU - Yu, Jen

AU - Lee, Choonsik

AU - Chen, Chin Cheng

AU - Choi, J. Isabelle

AU - Lin, Haibo

AU - Akthar, Adil S.

AU - Akhter, Nausheen

AU - Mihalcik, Stephen A.

AU - Pankuch, Mark

AU - Parhar, Preeti K.

AU - Stutz, Michael D.

AU - Thukral, Arpi D.

AU - Mah, Dennis

AU - Tsai, Henry K.

AU - Paulus, Rebecca

AU - Haffty, Bruce G.

AU - Goyal, Sharad

AU - Yue, Ning J.

AU - Sturgeon, Jared D.

AU - Wilkinson, J. Ben

AU - Boggs, D. Hunter

AU - Cardan, Rex A.

AU - Dalton, Allison

AU - McDonald, Andrew

AU - Prior, Fred

AU - Mayadev, Jyoti S.

AU - Moiseenko, Vitali

AU - Narezkina, Anya

AU - Phreaner, Nicholas

AU - Rash, Dominique

AU - Seibert, Tyler

AU - Yashar, Catheryn

AU - Daugherty, Emily C.

AU - Mascia, Anthony

AU - Medek, Sara A.

AU - Meier, Teresa

AU - Bradley, Julie A.

AU - Lockney, Natalie

AU - Mailhot, Raymond B.

AU - Mendenhall, Nancy

AU - Rutenberg, Michael

AU - Harris, Eleanor E.

AU - Lyons, Janice

AU - Hong, Jack J.

AU - Kunaprayoon, Dan K.

AU - McAvoy, Sarah A.

AU - Manu Mysore, Mysore

AU - Nowak Choi, Kamila A.

AU - Patel, Akshar N.

AU - Vyfhuis, Melissa A.L.

AU - Wilson, Joelle

AU - Algan, Ozer

AU - Chen, Yong

AU - Henson, Christina E.

AU - Dvorak, Tomas

AU - Willoughby, Twyla

AU - Zeidan, Omar

AU - Berman, Abigail T.

AU - Chen, Et tsu

AU - Dong, Lei

AU - Driscoll, Amanda

AU - Feigenberg, Steven J.

AU - Feriozzi, Ashley

AU - Hencek, Carolyn

AU - Kolker, James D.

AU - Konski, Andre A.

AU - Ky, Bonnie

AU - Lin, Lilie L.

AU - Novick, Kristina L.

AU - Reza, Nosheen

AU - Siegal, Ann Marie

AU - Tabakha, Sara

AU - Taunk, Neil K.

AU - Wilcox, Nicholas

AU - Zou, Wei

AU - Bhooshan, Neha

AU - Croley, Richard

AU - Weksberg, David C.

AU - Ahmad, Neelour

AU - Hoffman, Karen E.

AU - Joyner, Melissa M.

AU - Mitchell, Melissa P.

AU - Poenisch, Falk

AU - Smith, Benjamin D.

AU - Strom, Eric A.

AU - Vallabhaneni, Srilakshmi

AU - Cheng, Richard

AU - Kang, Kylie H.

AU - Kim, H. Katherine

AU - Kim, Janice N.

AU - Wang, Waylene A.

AU - Wong, Tony

AU - Bosch, Walter

AU - Mitchell, Joshua

AU - Straube, William

AU - Zoberi, Imran

AU - Balanescu, Dinu

AU - Chen, Peter Y.

AU - Dilworth, Joshua T.

AU - Ding, Xuanfeng

AU - Donisan, Teodora

AU - Hamstra, Daniel A.

AU - Daniella Dang, Phuong

AU - Katz, Stanford

AU - Wang, Chiachien J.

AU - Terry Wu, Wu

PY - 2024/9/1

Y1 - 2024/9/1

N2 - Purpose: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). Methods and Materials: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Results: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction – General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. Conclusions: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

AB - Purpose: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). Methods and Materials: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). Results: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction – General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. Conclusions: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

UR - http://www.scopus.com/inward/record.url?scp=85192746169&partnerID=8YFLogxK

U2 - 10.1016/j.ijrobp.2024.03.020

DO - 10.1016/j.ijrobp.2024.03.020

M3 - Article

C2 - 38739047

AN - SCOPUS:85192746169

SN - 0360-3016

VL - 120

SP - 149

EP - 161

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

IS - 1

ER -

Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial

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