Survivorship care planning for patients with prostate cancer is particularly important because of the high incidence rates of prostate cancer among men in the United States [14], the frequent occurrence of side effects due to treatments with curative intent [15-22] (eg, urinary, sexual, bowel, and hormonal symptoms; emotional distress; pain; fatigue; and sleep disturbance), and reduced QOL caused by these symptoms. Most patients are reluctant to talk with professionals or at support groups about their prostate cancer and its impact on their lives due to the sensitive nature of prostate cancer and its symptoms [23]. For patients in an intimate relationship, the effects of prostate cancer symptoms on their partners’ QOL are similar to or worse than the effects on their own QOL [24,25]. Management of these negative effects has been an unaddressed supportive care need for survivors and their partners [26-28]. The IOM [3] and American Cancer Society (ACS) [29] cancer care guidelines call for programs that address treatment-related effects, promote healthy behaviors, and maintain QOL for patients and their families.

To address the unmet care needs of patients and their partners, our interdisciplinary research team developed a couple-focused tailored prostate cancer education mHealth program, Prostate Cancer Education and Resources for Couples (PERC) [30] based on scientific evidence and input from three groups of stakeholders: patients, partners, and cancer care providers. The theory-driven PERC program aims to improve QOL for both patients and partners through tailored content and a set of features that provide information and skills training, as well as increase their self-efficacy, social support, and health behaviors for symptom management [30]. In the two pilot feasibility studies we conducted during PERC development, prostate cancer patients and partners reported high satisfaction with PERC. They reported that PERC was simple and easy to use and that it provided quality information that improved their symptom management and QOL. Our pilot participants also suggested vigorously advertising PERC and “having the program available at physicians’ offices” so that “all prostate cancer patients and their families can access it.” [30].

To strengthen survivorship care planning for patients with localized prostate cancer and respond to our pilot participants’ suggestions, we proposed to use SCPs as a vehicle for consistent and timely delivery of PERC and to enhance the standardized SCPs (hereafter, ESCP: enhanced survivorship care plan). We used the theoretical framework adapted from the Transactional Model of Stress and Coping [31] and family systems theory [32-34] to guide the development of the ESCP for prostate cancer patients in an intimate relationship. In this framework, personal, couple, and cancer-related factors are precursors (antecedents) of patients’ and partners’ QOL (primary outcomes) and also have indirect effects on QOL through secondary outcomes including appraisals of symptoms and coping resources (self-efficacy in symptom management, social support, and healthy lifestyle behaviors). The framework shows that patients and partners manage prostate cancer symptoms interdependently (when one person functions poorly, the other person is negatively affected [33,35]). This shapes their appraisals, coping resources, and ultimately affects the QOL outcome of each of the individuals.

In this proof-of-concept randomized controlled pilot trial, our primary objective is to examine the feasibility of delivering an ESCP (ie, standard SCP enhanced by the PERC program) to patients and partners. Our secondary objective of this study is to estimate the magnitude of potential benefit of the ESCPs. Compared with patients and partners who received the standardized SCP, we hypothesize that patients and partners using the ESCP will report greater improvement, from baseline (T1) to follow-up (T2), in QOL, self-efficacy in symptom management, social support, health behaviors to manage symptoms, and appraisals of prostate cancer symptoms. In addition, we hypothesize that patients receiving the standardized SCP and ESCP will differ in the number of visits to posttreatment care services between T1 and T2.

This study will test the feasibility of a two-group randomized controlled pilot trial using prepost mixed-method design. Patients and their partners will be randomly assigned to the SCP (control) or the ESCP (intervention) groups. Couples will complete study measures at T1 (before randomization) and T2 (4 months later).

A total of 50 men who have recently completed initial treatment for localized prostate cancer and their partners will participate in this feasibility and proof-of-concept study. The eligible patients must (1) be within 16 weeks of completing their initial treatment with curative intent for localized prostate cancer (ie, prostatectomy or radiotherapy with or without hormonal treatment) [36] at the genitourinary and radiation oncology clinics of the two comprehensive cancer centers in the southeast of United States; (2) not be receiving treatment currently or within the past year for another cancer; and (3) have a partner who is 18 years of age or older, not receiving cancer treatment currently or within the past year, and willing to participate.

Patients and their partners will be removed from this study if she or he is diagnosed with a new type of cancer, starts a new treatment for another cancer during the study period, or decides to withdraw from the study voluntarily. Patients and their partners will be excluded from the study if either partner does not read and speak English as evidenced by their understanding and responses to screening questions and self-reported ability to read English or has cognitive impairment (assessed by the short portable mental status questionnaire).

The research staff will use convenience sampling to recruit patients and partners from the genitourinary and radiation oncology clinics of two large comprehensive cancer centers in the southeast United States, where at least 400 men with localized prostate cancer receive treatment annually, and about 25% are African Americans, ensuring successful recruitment for this study. We will recruit couples based on procedures used successfully in the past by other researchers [37] and in our pilot study [30]. After Institutional Review Board approval, the project coordinator will identify potentially eligible patients using patient scheduling systems. The project coordinator then will see patients who meet the inclusion criteria before their SCP follow-up visit. The coordinator will provide study information, screen the patient and his partner for their eligibility and willingness to participate, obtain informed consent, and collect baseline data via telephone survey. For patients whose partners are not present at the clinic, the project coordinator will screen and consent the patients and partners and answer their questions via telephone after eligible patients give permission to contact their partners.

To our knowledge, this is the first study to integrate a tailored mHealth symptom self-management program with the SCP via EHR to enhance survivorship care planning and patient and family self-management. This study examines a new model of care that addresses the discord between the mandates and recommendations for survivorship care planning and scientific evidence of SCP effectiveness during care transition from end of treatment to self-management at home. We use SCPs as a vehicle to deliver mHealth programs (such as PERC) that provide a one-stop, comprehensive information and skills training mHealth intervention, as well as a place to receive social support from multiple sources (dyadic, peer, and professional) to help patients and their partners manage prostate cancer, general symptoms, and promote health behaviors. Patients and partners can conveniently access the ESCP and the mHealth program based on their preferences and needs, regardless of time and location. This study is responsive to national priorities aimed to strengthen survivorship care planning, including calls from the IOM, ACS, and Cancer Moonshot for programs that address treatment-related effects and help cancer survivors and their families to maintain QOL.

This study also addresses the great unmet supportive care needs for managing effects of cancer and its treatment for patients and families [26-29]. The substantial travel, time, and expense required to participate in in-person, multi-session, couple-focused supportive care programs limit the accessibility of these programs for patients and partners. Scalable interventions are needed to address the gap in survivorship care planning. The use of SCPs, which is increasingly required components of survivorship care planning, to deliver the tailored mHealth PERC program may facilitate referral and uptake of evidence-based mHealth programs that can reach a larger number of patients and partners at a low cost.

The innovative program has the potential to be used across diverse types of settings to address an important and frequently occurring public health problem in the US health care system as more than 220,000 men each year get diagnosed with prostate cancer. After treatment, many prostate cancer survivors experience significant physical, functional, and emotional disturbances. A scalable low-cost intervention that is widely available through routine care, EHR, and the Web, such as the ESCP, adds a significant improvement over the currently existing options.

Finally, this study innovatively involves family caregivers in posttreatment oncologic care. Family caregivers, especially partners, are often negatively affected by cancer diagnosis and treatment and sometimes have worse QOL than patients with prostate cancer [25]. Partners are a major source of support and part of the care unit [57,58]. Patients and partners often have different perceptions about prostate cancer-related issues and difficulty discussing them [59,60]. Couples lack access to survivorship care programs because of suboptimal services and referrals [61], and the small number of programs available [28] (especially those that are couple-focused [62-68]). In this study, integration of a couple-focused tailored mHealth intervention into standard SCPs is an innovative approach to deliver survivorship care information to both cancer patients and their family caregivers, and to provide family- and patient-centered care.

The following limitations of this study warrant discussion. First, this study is conducted in two comprehensive cancer centers, and thus, findings may have limited generalizability to settings that do not have rich resources and support (such as community cancer centers). Recognizing this inherent limitation of pilot/feasibility studies at this stage, this formative work will inform our planned study in a broader range of clinical settings to test the efficacy of the ESCP in the near future. Anecdotally smaller cancer centers and hospitals often devote specific personnel for SCP implementation to be compliant with the mandate of Commission on Cancer, which would facilitate the ESCP delivery. The additional mHealth programs such as PERC may also have more significant effects for patients receiving care at local community hospitals and cancer centers that lack personnel and resources for posttreatment care and educational resources for patients and their families.

Second, some patients and their partners may not have access to the Internet and/or a computer. We will provide cellular-ready touchscreen tablets with a 1-year 3G data plan to these couples to ensure equal access to the mHealth program.

Next, some patients and their partners may have low computer/Internet literacy, which may reduce their enthusiasm in participating in this study. To address this concern, our research staff will bring an iPad when recruiting potential participants at the clinics and show them that we designed our study website so that it requires minimum skills to navigate. Participants in our pilot studies rated our program as very simple and intuitive to use. We have developed step-by-step instructions on how to use the Internet and the study website and will provide participants these instructions by mail, email, or phone. We have also posted an instructional video on the homepage. We will provide technical support to help troubleshoot operational problems, although, in the previous testing, no pilot participants used the support.

Because PERC is a couple’s intervention that is tailored to the needs of intimate couples, we will exclude nonpartnered patients because they face different challenges than patients with partners [69]. Finally, at this time, our intervention is only available to English-speaking patients and their partners.

Compared with the standardized SCPs, ESCPs will take patients’ and partners’ specific needs into consideration and provide more detailed content that is tailored to their preferences. Implementing ESCPs will change the status quo of patients receiving relatively generic SCPs. Compared with the standardized SCPs with generic information, the ESCP will provide an empowering mHealth program (PERC) that allows patients and partners to assess their own symptoms and care needs, as well as provide resources to address their needs as they transition to posttreatment self-care at home. Compared with traditional face-to-face or telephone consultations that provide posttreatment care and education, the ESCP in this study will empower patients and their families to self-manage their symptoms and promote healthy behaviors, and thus, enable health care providers to focus their limited resources on patients who experience the most severe issues and symptoms. Survivorship care plans enhanced by a mHealth or Web-based program can also help consistently deliver posttreatment supportive care services to a larger number of patients and their families, at a low cost.

The study will explore a new model of care that enhances survivorship care planning. Innovative integration of PERC with SCPs (ESCPs) will provide a tool that helps patients and partners to tailor their posttreatment symptom self-management programs based on their needs and preferences. Findings from this study will help design a definitive randomized clinical trial to test the efficacy of ESCP, a potentially scalable program.