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This project explores a new model of care that enhances survivorship care planning and promotes health for men with localized prostate cancer transitioning to posttreatment self-management. Survivorship care planning is important for patients with prostate cancer because of its high incidence rate in the United States, the frequent occurrence of treatment-related side effects, and reduced quality of life (QOL) for both men and their partners. A key component of comprehensive survivorship care planning is survivorship care plans (SCPs), documents that summarize cancer diagnosis, treatment, and plans for follow-up care. However, research concerning the effectiveness of SCPs on patient outcomes or health service use has thus far been inconclusive. SCPs that are tailored to individual patients’ needs for information and care may improve effectiveness.
This study aims to examine the feasibility of an enhanced survivorship care plan (ESCP) that integrates a symptom self-management mHealth program called Prostate Cancer Education and Resources for Couples (PERC) into the existing standardized SCP. The specific aims are to (1) examine the feasibility of delivering ESCPs and (2) to estimate the magnitude of benefit of ESCPs.
We will use a two-group randomized controlled pretest-posttest design and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, we will assess the feasibility of ESCP by recruitment, enrollment, and retention rates; program satisfaction with the ESCP; and perceived ease of use of the ESCP. To achieve the secondary aim, we will compare the ESCP users with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL); secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms); and number of visits to posttreatment care services between T1 and T2. We will assess the primary and secondary outcomes using measurements with sound psychometrical properties. We will use a qualitative and quantitative mixed methods approach to achieve the research aims.
This project is ongoing and will be completed by the end of 2018.
The results from this study will help design a definitive randomized trial to test the efficacy of the ESCPs, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.
A key component of cancer survivorship care planning is survivorship care plans (SCPs), documents intended in part to improve survivors’ understanding of treatment-related symptoms, and ultimately, to improve patient outcomes such as quality of life (QOL) by summarizing cancer diagnosis, treatment, and follow-up care [
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 [
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) [
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 [
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) [
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 [
After the T1 survey completion, couples will be randomized to the standardized SCP or the ESCP groups using a 1:1 ratio; 25 couples in each group (N=50 couples). The study statistician will generate, using an SAS program (SAS Institute Inc., Cary, NC, USA), a stratified
After logging into the study website that is embedded in the SCPs, control participants will be directed to the National Cancer Institute (NCI) prostate cancer website. A range of sources including NCI and ACS are routinely available in standardized SCPs to all patients. We utilize the auto-direction to the NCI website as an attention control to improve blindness during the randomization process. Furthermore, we include the NCI website to ensure that participants in the control group have structured access to evidence-based and guideline-adherent information and equivalence between control and experimental groups.
The use of SCPs is part of routine care at the genitourinary and radiation oncology clinics. After completing initial treatment for prostate cancer, patients’ clinicians will complete and print a standardized SCP adapted from the American Society of Clinical Oncology template, review it with the patient (and their families) in a private room behind a closed door or via telephone, and provide him with a copy. The SCP will also be sent to the patient’s primary care provider. The standardized SCP’s section about possible late- and long-term treatment effects provides a generic summary of the side effects of the patient’s treatment; options for managing the side effects; and recommendations for diet, physical activities, smoking cessation, and stress. All of this information is brief and is nonspecific to individual patients. There is no content about caregiver and caregiving issues during posttreatment survivorship in the standardized SCP.
Participants randomized to the intervention group will receive the same SCP but will be directed to the PERC intervention website after logging into our study website instead of the control group’s NCI website. PERC includes 12 modules about how couples can work effectively as a team, assess and better manage prostate cancer treatment-related side effects and symptoms (including urinary and bowel problems, sexual dysfunction, hormonal symptoms, pain, fatigue, sleep disturbance, and stress), and improve healthy behaviors. PERC also facilitates social support for the patient and his partner via postmodule assignments, a moderated online forum, meetings with a health educator, and a resource center that connects participants and their partners to tools for symptom tracking and monitoring, as well as local and national support groups and resources. Participants in the intervention group will have 15 weeks to complete the PERC intervention.
To achieve our primary objective of testing the feasibility of the ESCP, we will collect both quantitative and qualitative data.
Summary of measures at baseline (T1) and 4 months post baseline (T2).
Variables and Measurementa | Data sourceb | Group | T1 | T2 | Cronbach alpha | PERC programc | ||
Screening, enrollment, and retention rates: research activity logs; field notes | AD | Bothd | Yes | Yes | N/Ae | N/A | ||
Self-reported program use | PT, SP | Both | Yes | N/A | N/A | |||
Web activity: use NCI versus PERC or not, number of logins | Tracking | Both | Yes | Yes | N/A | Built in tracking system | ||
Program satisfaction and perceived ease of use: Usability Scale [ |
PT, SP | Both | Yes | Yes | N/A | N/A | ||
Participants’ experiences: exit interview | PT, SP, AD | Both | No | Yes | N/A | N/A | ||
Quality of life (overall, physical, emotional, and social well-being): functional assessment of chronic illness therapy general scale (27-item) [ |
PT, SP | Both | Yes | Yes | .90 [ |
Allf | ||
Number of visits to post treatment care services: medical records | EHR, PT | Both | No | Yes | N/A | All | ||
Appraisal of PCa symptoms: 4-item bother questionnaire [ |
SP | Both | Yes | Yes | .74-.9 [ |
All | ||
Self-efficacy in symptom management: 9-item cancer self-efficacy scale [ |
PT, SP | Both | Yes | Yes | .91-.96 [ |
All | ||
Social support: PROMIS SF V2.0 informational, instrumental, and emotional support scales [ |
PT, SP | Both | Yes | Yes | .74-.86 [ |
PA; CR | ||
Health behaviors: physical activity and nutrition in health promoting lifestyle profile II. [ |
PT, SP | Both | Yes | No | .75-.92 [ |
HB; CR | ||
Demographic characteristics: age, race/ethnicity |
PT, SP | Both | Yes | No | N/A | N/A | ||
Type of PCa treatment: SCP record | PT | Both | Yes | No | N/A | N/A | ||
Comorbidities: 13-item Charlson comorbidity index—brief [ |
PT, SP | Both | Yes | Yes | .73-.88 [ |
N/A | ||
General symptoms: 21-item Risk of Distress General Symptom Scale [ |
PT, SP | Both | Yes | Yes | .76-.84 [ |
GS | ||
PCa symptoms: expanded prostate cancer index composite 26 [ |
PT | Both | Yes | Yes | .74-.90 [ |
PCa |
aESCP: enhanced survivorship care plan; NCI: National Cancer Institute; PERC: prostate cancer education and resources for couples; SCP: survivorship care plan; PCa: prostate cancer related symptoms; PROMIS: Patient Reported Outcome Measures.
bAD: administrative data and field notes; PT: patient; SP: spouse/partner; EHR: electronic health record
cThe elements in PERC that will impact the outcomes. PA: postsession assignment; CR: online chat room; HB: healthy behaviors (healthy eating and physical activity); GS: general symptoms of pain, fatigue, sleep disturbance, emotional distress.
dBoth: participants in SCP only and ESCP groups.
eN/A: not applicable.
fAll: all elements in PERC (mentioned above).
For quantitative data, we will obtain participants’ program satisfaction and perceived ease of use using the usability scale [
To collect qualitative data, we will review research activity logs, field notes, participant screening data, and participant self-reported program use, as well as conduct a qualitative postintervention exit interview after study completion. In preparation for the postintervention exit interview, we will ask all participants at the T2 survey whether they are willing to talk via telephone about their experiences of using SCPs or ESCPs. Research staff will select 20 patient-partner dyads for interviews using purposeful sampling to ensure inclusion of at least one patient from each of the following groups: having/not having Internet access, having an education level of less than high school versus higher than high school, living in rural versus urban residential locations, and being African American versus white. We anticipate that these characteristics influence people’s perceptions and use of SCPs or ESCPs. Guided by a set of open-ended questions and probes, patients and partners will be interviewed together (with the telephone speaker on) and then separately (when the interviewee is alone and feels comfortable to speak freely) to learn about their shared and discrepant perceptions about the SCP or ESCP use. All interviews, conducted in a closed room, will be audio-recorded and transcribed for qualitative analysis. Research staff will also collect data about the number of visits to the genitourinary and radiation oncology clinics, patients’ primary care provider, and other providers including emergency room visits and hospitalizations.
For our secondary objective, we will evaluate participant outcomes at T1 and T2 to test the potential magnitude of benefits of the ESCP. We will obtain participant responses to structured questionnaires via telephone at T1 and T2. These Likert scales have been developed by research experts and tested for validity and reliability in previous projects [
There will be 25 couples each in the SCP and ESCP groups. Conservatively, we assume that we will have complete data on 23 couples per group, which is equivalent to assuming an attrition rate of 8%. Our attrition rate is based on a previous pilot study testing the feasibility of PERC in a population of patients with newly diagnosed prostate cancer and their partners recruited from the UNC Medical Center Genitourinary clinic. Unless otherwise specified, all tests will be one-sided at a .05 significance level.
For our primary objective, we base our calculations on the percentage of reviewed PERC sessions that are consistent with the symptoms patients reported, where we consider the study feasible if 80% of the reviewed PERC sessions are consistent. On the basis of our assumed sample size, we can estimate the percentage of reviewed PERC sessions that are consistent with reported symptoms with a margin of error of 16% with 95% CI. We will first use a quantitative and qualitative mixed method to analyze the data [
Interview data will be coded in atlas.ti (ATLAS.ti for Windows. Berlin: Scientific Software Development). Version 7.5.16, 1993-2019) by the investigators and the research assistants using template analysis [
Descriptive statistics will be calculated for secondary outcomes: QOL; appraisal of prostate cancer symptoms; self-efficacy in symptom management, social support, and health behaviors; number of patient visits to posttreatment care services; and Charlson comorbidity index, expanded prostate cancer index composite (EPIC), and General Symptom Subscale scores in the Risk of Distress Scale, for participants and partners, by time point and by group. All analyses will be conducted using an intention-to-treat approach, in which all randomized participants will be analyzed according to their assigned group, regardless of the extent of intervention received. We will use a stratified two-sample
To assess the effect of group on the outcome measures for QOL, self-efficacy in symptom management, social support, and health behaviors, while accounting for the fact that couples have correlated measurements, we will fit a linear mixed model to the change score (ie, change from T1 to T2) for each outcome measure, where we will include the following as fixed effects: group membership (SCP, ESCP), couple member (patient, partner), type of prostate cancer treatment, the outcome’s measure at T1, age, income, the Charlson comorbidity index score, and the differences in the Charlson index, EPIC, and general symptom scale scores between T1 and T2. To account for the correlation between each patient and partner in each couple, we will also include couple membership as a random effect. For appraisal of symptoms, which was only measured in partners, we will fit an analysis of covariance model to its change score, including the same fixed effects as those used for QOL, self-efficacy in symptom management, social support, and health behaviors. We will fit a Poisson regression model to the number of patient visits to posttreatment care services at T2, where we will include group membership as a predictor while controlling for the following effects: treatment type, age, income, the Charlson comorbidity index, EPIC, and general symptom scale score at T2.
As this is an exploratory proof-of-concept study, rather than a confirmatory study, we will not adjust for multiplicity when computing the CIs for these feasibility measures or conduct comparisons. Unless otherwise specified, all tests will be one-sided at a .05 significance level. All analyses will be conducted using SAS 9.4 (SAS Institute Inc., Cary, NC, USA).
This project will run for 2 years and will be completed by the end of 2018. We have obtained approval from the Institutional Review Board at the two comprehensive cancer centers in the southeast United States. We have hired and trained research staff, including the project coordinator and the interventionist; set up the database using RedCap (Research Electronic Data Caputure, 2009); developed and refined protocols for all research activities; and updated the PERC website content and functionality.
We have also met with the clinical champions at the genitourinary clinics at both institutions and refined the recruitment and SCP implementation process. One of the genitourinary clinics is encountering a major nursing staff turnover, causing omission of SCP implementation to most patients at the clinic. Although the clinic is hiring new nursing staff, an oncology nurse practitioner student who is also a nurse navigator at the cancer hospital will work closely with the nurse practitioners, physician assistant, and physicians to help generate and deliver the SCPs with the embedded study website to eligible patients.
We started recruitment at the end of June 2017. As of the end of September 2017, we have consented 22 patient-partner dyads and completed the baseline survey among 16 couples. These couples have been randomly assigned to either the standardized SCP (with the NCI prostate cancer website) or the ESCP group and received the standardized SCPs. After receiving the SCPs, these couples will start their online programs. We will monitor and facilitate PERC intervention use and recruit participants for the next 6 months or until we successfully enroll 50 eligible patient-partner couples.
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 [
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 [
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 [
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.
American Cancer Society
administrative data and field notes
online chat room
electronic health record
expanded prostate cancer index composite
enhanced survivorship care plan
general symptoms of pain
healthy behaviors
Institute of Medicine
National Cancer Institute
postsession assignment
prostate cancer related symptoms
prostate cancer education and resources for couples program
patient
quality of life
survivorship care plan
spouse/partner
This project is supported by the NCI (1 R21 CA212516-01). The authors gratefully acknowledge the technical support of the Nutrition Communication for Health Applications and Interventions core for developing the intervention website. The authors thank the staff, advisory committees, and research participants participating in the pilot intervention studies for their important contributions that have made the study possible.
None declared.