Exploring Interactive Survivorship Care Plans to Support Breast Cancer Survivors: Protocol for a Randomized Controlled Trial

Abstract

Background Breast cancer is the most common form of cancer among American women, accounting for 23% of all cancer survivors nationally. Yet, the availability of adequate resources and tools for supporting breast cancer survivors has not kept up with the rapid advancement in treatment options, resulting in unmet supportive care needs, particularly among low-income and minority populations. This study explores an alternative means of delivering breast cancer survivorship care plans (SCPs), with the aim of improving survivor morbidity, patient knowledge, and self-management of treatment-related symptoms, as well as addressing inconsistencies in follow-up care visits. Objective The overall goal of this study is to improve the uptake of SCP recommendations via an educational intervention for breast cancer survivors, to improve treatment-related morbidity, patient knowledge, self-management, and adherence to follow-up visits. The specific aims of the study are to (1) evaluate the feasibility of the online SCP, and (2) assess the impact of the online SCP on survivorship outcomes. Methods We will enroll 50 breast cancer survivors who have completed initial breast cancer treatment into a 2-armed, randomized, waitlist-controlled pilot trial, and collect data at baseline and 6 months. For the first aim, we will use mixed methods, including surveys and personal interviews among the intervention group, to determine the feasibility of providing an online, interactive SCP (called ACESO) based on the survivors’ online user experience and their short-term adoption. For the secondary aim, we will compare the 2 groups to assess the primary outcomes of survivor knowledge, self-efficacy for self-management, perceived peer support, and adherence to SCP-recommended posttreatment follow-up visits to oncology and primary care; and the secondary outcomes of treatment-related morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality). We assess these outcomes by using measurements from validated instruments with robust psychometric properties. Results We have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors. Approval for the study protocol has been obtained from the Institutional Review Board. An advisory board has also been established to provide oversight and recommendations on the conduct of the study. The study will be completed over a period of 2 years. Conclusions The results of this pilot study will inform the feasibility and design of a larger-scale pragmatic trial to evaluate the impact of an online breast cancer SCP on treatment-related morbidity and self-efficacy for self-management. International Registered Report Identifier (IRRID) PRR1-10.2196/23414

Patient preference attributes in eHealth interventions for cancer‐related fatigue: A scoping review

“…For most interventions, the study was performed in the United States ( n = 12) (Cairo et al, 2020 ; Henry et al, 2018 ; Kapoor & Nambisan, 2020 ; Kelleher et al, 2021 ; Kubo et al, 2018 ; Lengacher et al, 2018 ; Nápoles et al, 2019 ; Owen et al, 2017 ; Price‐Blackshear et al, 2020 ; Ritterband et al, 2012 ; Smith et al, 2019 ; Spahrkäs et al, 2020b ), followed by the Netherlands ( n = 6) (Abrahams et al, 2015 ; Dozeman et al, 2017 ; van den Berg et al, 2012 ; Willems et al, 2015 ; Wolvers et al, 2015 ). A few interventions ( n = 3) (Ritterband et al, 2012 ; Spahrkäs et al, 2020b ; Urech et al, 2018 ; Zachariae et al, 2018 ) were studied in multiple countries.…”

“…A few interventions ( n = 3) (Ritterband et al, 2012 ; Spahrkäs et al, 2020b ; Urech et al, 2018 ; Zachariae et al, 2018 ) were studied in multiple countries. For more than half of the interventions ( n = 18), the study was performed only in breast cancer patients (Abrahams et al, 2015 ; Cairo et al, 2020 ; Delrieu, Anota, et al, 2020 ; Dozeman et al, 2017 ; Galiano‐Castillo et al, 2013 ; Henry et al, 2018 ; Holtdirk et al, 2020 ; Kapoor & Nambisan, 2020 ; Kelleher et al, 2021 ; Lee et al, 2014 ; Lengacher et al, 2018 ; Mendes‐Santos et al, 2019 ; Nápoles et al, 2019 ; Price‐Blackshear et al, 2020 ; Smith et al, 2019 ; van den Berg et al, 2012 ; Zachariae et al, 2018 ; Zhou et al, 2020 ), and in studies with mixed samples ( n = 14), a mean of 52% of the participants had breast cancer (Bray et al, 2017 ; Bruggeman‐Everts et al, 2017 ; Falz et al, 2021 ; Foster et al, 2016 ; Kubo et al, 2018 ; Mikolasek et al, 2021 ; Owen et al, 2017 ; Puszkiewicz et al, 2016 ; Spahrkäs et al, 2020b ; Urech et al, 2018 ; Willems, Bolman, et al, 2017 ; Yun et al, 2012 ; Zernicke et al, 2016 ). For three interventions, no percentage breast cancer patients was known yet, as only a protocol was available (Carlson et al, 2019 ; Corbett et al, 2016 ; Subnis et al, 2020 ).…”

“…For three interventions, no percentage breast cancer patients was known yet, as only a protocol was available (Carlson et al, 2019 ; Corbett et al, 2016 ; Subnis et al, 2020 ). In total, we found seven interventions for which only a protocol was available (Carlson et al, 2019 ; Corbett et al, 2016 ; Falz et al, 2021 ; Kapoor & Nambisan, 2020 ; Kelleher et al, 2021 ; Mendes‐Santos et al, 2019 ; Subnis et al, 2020 ). Ten interventions reported long‐term results, varying from 2 to 12 months after finishing the intervention (Bray et al, 2017 ; Bruggeman‐Everts et al, 2017 ; Foster et al, 2016 ; Galiano‐Castillo et al, 2016 ; Holtdirk et al, 2021 ; Urech et al, 2018 ; van den Berg et al, 2015 ; Willems, Mesters, et al, 2017 ; Wolvers, 2017 ; Zachariae et al, 2018 ).…”

“…eHealth interventions are relatively new, the oldest articles were published in 2012 (Ritterband et al, 2012 ; van den Berg et al, 2012 ; Yun et al, 2012 ). Also, more than half of the studies (n = 21) were published in the last five years (2017–2021) (Bray et al, 2017 ; Cairo et al, 2020 ; Carlson et al, 2019 ; Delrieu et al, 2018 ; Dozeman et al, 2017 ; Falz et al, 2021 ; Henry et al, 2018 ; Holtdirk et al, 2020 ; Kapoor & Nambisan, 2020 ; Kelleher et al, 2021 ; Kubo et al, 2018 ; Lengacher et al, 2018 ; Mendes‐Santos et al, 2019 ; Mikolasek et al, 2018 ; Nápoles et al, 2019 ; Owen et al, 2017 ; Price‐Blackshear et al, 2020 ; Smith et al, 2019 ; Spahrkäs et al, 2020a ; Subnis et al, 2020 ; Zhou et al, 2020 ).…”

“…For more than half of the interventions (n = 18), the study was performed only in breast cancer patients (Abrahams et al, 2015;Cairo et al, 2020;Delrieu, Anota, et al, 2020;Dozeman et al, 2017;Galiano-Castillo et al, 2013;Henry et al, 2018;Holtdirk et al, 2020;Kapoor & Nambisan, 2020;Kelleher et al, 2021;Lee et al, 2014;Lengacher et al, 2018;Mendes-Santos et al, 2019;Nápoles et al, 2019;Price-Blackshear et al, 2020;Smith et al, 2019;van den Berg et al, 2012;Zachariae et al, 2018;Zhou et al, 2020), and in studies with mixed samples (n = 14), a mean of 52% of the participants had breast cancer (Bray et al, 2017;Bruggeman-Everts et al, 2017;Falz et al, 2021;Foster et al, 2016;Kubo et al, 2018;Mikolasek et al, 2021;Owen et al, 2017;Puszkiewicz et al, 2016; 1Â during-4Â after 2/5 with significant improvement (Delrieu et al, 2018;Delrieu, Anota, et al, 2020; Single (p < 0.05)* (Kanera et al, 2017;Willems et al, 2015; 462 ( 409 Ongoing (Foster et al, 2015(Foster et al, , 2016Grimmett e...…”