Ted A Skolarus1,2, Tabitha Metreger1, Daniela Wittmann2, Soohyun Hwang3, Hyungjin Myra Kim1,2, Robert L Grubb4, Jeffrey R Gingrich5, Hui Zhu6, John D Piette1,7, Sarah T Hawley1,2. 1. 1 Veterans Affairs Health Services Research and Development Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI. 2. 2 University of Michigan, Ann Arbor, MI. 3. 3 University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC. 4. 4 Medical University of South Carolina, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC. 5. 5 Duke University, Durham Veterans Affairs Healthcare System, Durham, NC. 6. 6 Case Western Reserve University, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH. 7. 7 University of Michigan School of Public Health, Ann Arbor, MI.
Abstract
PURPOSE: This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden. METHODS: A total of 556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites. Participants were randomly assigned to intervention (n = 278) or usual care (n = 278) groups. We compared differences in the primary (symptom burden according to Expanded Prostate Cancer Index Composite-26 [EPIC], confidence in self-management) and secondary outcomes between groups using intent-to-treat analyses. We compared domain-specific changes in symptom burden from baseline to 5 and 12 months among the intervention group according to the primary symptom focus area (urinary, bowel, sexual, general) of participants. RESULTS: Most of the prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7% v 46.2% who underwent surgery), and the mean age was 67 years. There were no baseline differences in urinary, bowel, sexual, or hormonal domain EPIC scores across groups. We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant. No differences were found in secondary outcomes; however, coping appraisal was higher (2.8 v 2.6; P = .02) in intervention-arm patients at 5 months. In subgroup analyses, intervention participants reported improvement from baseline at 5 and 12 months in their symptom focus area domains. CONCLUSION: This intervention was well received among veterans who were long-term survivors of prostate cancer. Although overall outcome differences were not observed across groups, the intervention tailored to symptom area of choice may hold promise to improve associated burden.
RCT Entities:
PURPOSE: This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden. METHODS: A total of 556 prostate cancer survivors who, more than 1 year after treatment, were experiencing symptom burden were recruited from April 2015 to February 2017 across four Veterans Affairs sites. Participants were randomly assigned to intervention (n = 278) or usual care (n = 278) groups. We compared differences in the primary (symptom burden according to Expanded Prostate Cancer Index Composite-26 [EPIC], confidence in self-management) and secondary outcomes between groups using intent-to-treat analyses. We compared domain-specific changes in symptom burden from baseline to 5 and 12 months among the intervention group according to the primary symptom focus area (urinary, bowel, sexual, general) of participants. RESULTS: Most of the prostate cancer survivors in this study were married (54.3%), were white (69.2%), were retired (62.4%), and underwent radiation therapy (56.7% v 46.2% who underwent surgery), and the mean age was 67 years. There were no baseline differences in urinary, bowel, sexual, or hormonal domain EPIC scores across groups. We observed higher EPIC scores in the intervention arm in all domain areas at 5 months, though differences were not statistically significant. No differences were found in secondary outcomes; however, coping appraisal was higher (2.8 v 2.6; P = .02) in intervention-arm patients at 5 months. In subgroup analyses, intervention participants reported improvement from baseline at 5 and 12 months in their symptom focus area domains. CONCLUSION: This intervention was well received among veterans who were long-term survivors of prostate cancer. Although overall outcome differences were not observed across groups, the intervention tailored to symptom area of choice may hold promise to improve associated burden.
Authors: Anna Bill-Axelson; Lars Holmberg; Mirja Ruutu; Michael Häggman; Swen-Olof Andersson; Stefan Bratell; Anders Spångberg; Christer Busch; Stig Nordling; Hans Garmo; Juni Palmgren; Hans-Olov Adami; Bo Johan Norlén; Jan-Erik Johansson Journal: N Engl J Med Date: 2005-05-12 Impact factor: 91.245
Authors: David C Miller; Martin G Sanda; Rodney L Dunn; James E Montie; Hector Pimentel; Howard M Sandler; William P McLaughlin; John T Wei Journal: J Clin Oncol Date: 2005-04-20 Impact factor: 44.544
Authors: John T Wei; Rodney L Dunn; Howard M Sandler; P William McLaughlin; James E Montie; Mark S Litwin; Linda Nyquist; Martin G Sanda Journal: J Clin Oncol Date: 2002-01-15 Impact factor: 44.544
Authors: A L Potosky; J Legler; P C Albertsen; J L Stanford; F D Gilliland; A S Hamilton; J W Eley; R A Stephenson; L C Harlan Journal: J Natl Cancer Inst Date: 2000-10-04 Impact factor: 13.506
Authors: Jack A Clark; Thomas S Inui; Rebecca A Silliman; Barbara G Bokhour; Steven H Krasnow; Richard A Robinson; Monica Spaulding; James A Talcott Journal: J Clin Oncol Date: 2003-10-15 Impact factor: 44.544
Authors: Gunnar Steineck; Fred Helgesen; Jan Adolfsson; Paul W Dickman; Jan-Erik Johansson; Bo Johan Norlén; Lars Holmberg Journal: N Engl J Med Date: 2002-09-12 Impact factor: 91.245
Authors: Arnold L Potosky; William W Davis; Richard M Hoffman; Janet L Stanford; Robert A Stephenson; David F Penson; Linda C Harlan Journal: J Natl Cancer Inst Date: 2004-09-15 Impact factor: 13.506
Authors: A van der Hout; C F van Uden-Kraan; K Holtmaat; F Jansen; B I Lissenberg-Witte; G A P Nieuwenhuijzen; J A Hardillo; R J Baatenburg de Jong; N L Tiren-Verbeet; D W Sommeijer; K de Heer; C G Schaar; R J E Sedee; K Bosscha; M W M van den Brekel; J F Petersen; M Westerman; J Honings; R P Takes; I Houtenbos; W T van den Broek; R de Bree; P Jansen; S E J Eerenstein; C R Leemans; J M Zijlstra; P Cuijpers; L V van de Poll-Franse; I M Verdonck-de Leeuw Journal: Internet Interv Date: 2021-07-15
Authors: Karly M Murphy; Christina Sauer; Dershung Yang; Niina Hass; Kristian Novakovic; Brian Helfand; Robert Nadler; Benjamin D Schalet; David Victorson Journal: Cancer Nurs Date: 2022 Jan-Feb 01 Impact factor: 2.592
Authors: Sara Faithfull; Jane Cockle-Hearne; Agnieszka Lemanska; Sophie Otter; Simon S Skene Journal: Support Care Cancer Date: 2021-12-21 Impact factor: 3.359
Authors: Christopher J D Wallis; James W F Catto; Antonio Finelli; Adam W Glaser; John L Gore; Stacy Loeb; Todd M Morgan; Alicia K Morgans; Nicolas Mottet; Richard Neal; Tim O'Brien; Anobel Y Odisho; Thomas Powles; Ted A Skolarus; Angela B Smith; Bernadett Szabados; Zachary Klaassen; Daniel E Spratt Journal: Eur Urol Date: 2020-09-04 Impact factor: 20.096