Abstract P1-09-15: Randomized clinical trial assessing the impact of survivorship care plans on survivor knowledge
Authors: Tevaarwerk Amye J , Buhr Kevin A , Wisinski Kari B , Burkard Mark , Gribble Mindy , Hocking Willam , Sun Wenjun , Donohue SarahMaria , Zeal Jamie , Terhaar Abigail , Wiegman Douglas A , Sesto Mary E 
Published: May 2015

Abstract
Purpose: Efforts to inform survivors about long-term risks and planned follow-up after cancer treatment have increased. Survivorship Care Plans (SCPs) and care planning sessions have been recommended since 2005, yet the benefits of both SCP provision and care planning are only now being assessed. The impact of SCPs separate from care planning sessions is unclear, however SCPs alone require less time and cost to provide than SCPs combined with care planning sessions. We hypothesized that SCPs alone might enhance patient knowledge. In a randomized trial, we assessed change in patient knowledge of diagnosis, treatment, late/chronic side effects and followup care pre and post receipt of SCP.
Methods: Patients who completed primary treatment within the past 2 years for Stage 0-3 breast cancer were consented, enrolled, and randomized to immediate (intervention) versus delayed receipt (control) of an individualized SCP without care planning. All participants completed the Wisconsin Survey of DiagnOsis and Management in Breast cancer (WiSDOM-B), a test of knowledge about one’s own breast cancer diagnosis, treatment and late effects scored out of 40 points. The survey was completed at both baseline and at four weeks (prior to delayed receipt); the primary outcome was change in score. The study was designed with 90% power to detect a between-group difference of 4 points (out of 40 possible).
Results: Between November 2013 and March 2014, we recruited 64 women aged 36-78 with Stage 0-3 breast cancer. Most participants were Stage 1-2 (n=50, 79%) with n=7 (10.9%) in Stage 3. Most had received chemotherapy (62.5%), endocrine therapy (89.1%), or radiation (76.6%).
At baseline, the average WiSDOM-B score was 28.3 out of 40 (70.8%), range 15.5-38.5. There was no evidence of change in score from baseline to four weeks for either the immediate SCP group (+0.41, 95% CI [-0.97,+1.79]) or delayed receipt control group (+0.95, 95% CI [-0.48,2.38]). Observed variation was consistent with sample size assumptions, and the observed treatment difference (-0.55, 95% CI [-2.53,1.44], p=n.s.) ruled out the prespecified clinically significant effect size of +4.0 (+10%).
Overall, participants scored better on questions testing knowledge of diagnosis (side, year of diagnosis, lymph node test results, receptor status, and stage) and surgical side effects than on questions testing knowledge of other treatment (chemotherapy, radiation or endocrine therapy) side effects.
Participant satisfaction with knowledge and care team communication was collected pre and post SCP, as well as feedback on SCP content and use of the SCP. These and analyses of selected questions shown to change post SCP by Nissen et al will also be presented.
Conclusion: In a controlled, randomized clinical trial, receipt of a SCP without care planning sessions did not appear to significantly increase survivor knowledge about cancer diagnosis, treatment and followup as assessed by the WiSDOM-B survey. Efforts to improve survivor knowledge should investigate the impact of care planning sessions or other interactive health information tools. A second study of patients (n=64) randomized to immediate or delayed receipt of SCPs, in conjunction with care planning sessions, is currently enrolling.
Citation Format: Amye J Tevaarwerk, Kevin A Buhr, Kari B Wisinski, Mark Burkard, Mindy Gribble, Willam Hocking, Wenjun Sun, SarahMaria Donohue, Jamie Zeal, Abigail Terhaar, Douglas A Wiegman, Mary E Sesto. Randomized clinical trial assessing the impact of survivorship care plans on survivor knowledge [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-09-15.