Explanation for the choice of comparators {6b}

We use usual care plus the NCI prostate cancer website as the control condition. In usual care, patients access a range of sources (e.g., health providers, handouts and books, and online) to satisfy their information needs [41]. To ensure that our usual care participants access evidence-based, guideline-adherent information, we also give them access to the NCI website (http://www.cancer.gov/cancertopics/types/prostate) through the study website. The NCI website provides information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; and support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking. After logging in to the study website, usual care participants meet with the study educator at orientation using their preferred method (telephone or online) and then meet with the educator every 4 weeks via email. They receive general information about treatment and referral to the NCI website. Couples who fail to access the NCI website, as indicated by the Web activity tracking data, receive automatic messages via their preferred communication method (email, text, phone, or mail) to remind them to visit the website.

Intervention description {11a}

In response to the increased use of technology to access information (including by older adults) [42,43,44,45] and to promote and help the uptake of PERC, we use eHealth technologies to improve access to the knowledge and skills that are critical and sensitive during care transitions for both patients and their partners. The PERC website includes three major sections: (1) 10 education modules with post-session assignments, (2) a moderated online Forum, and (3) a Resource Toolbox. We provide links to scientific publications in the Resource Toolbox to satisfy the learning needs of participants with high education levels. PERC uses clear, easy-to-read text; minimizes webpage navigation redirects; and incorporates audio-enhanced slides, videos, and graphics in each module to reach people at different reading and education levels and with different learning styles. The research staff provides ongoing technical support via telephone and online during 8 am to 9 pm Monday to Saturday. In-person visits can be arranged if needed.

PERC also facilitates informational, appraisal, and emotional support from partners, peers, and professionals during care transitions. PERC assists couple support between the patient and his partner through couple-focused modules and post-session assignments in which couples practice effective communication skills; share with each other personal perceptions of and experiences with different symptoms; and collaboratively develop strategies to minimize negative perceptions and effects of these symptoms on their lives. As strongly recommended by our pilot participants [35], couples are encouraged to log in to PERC from the same computer so that they can work together, although they can use the program separately at their convenience.

Participants can obtain peer and professional support using the online Forum moderated by our trained nurse educator who has extensive knowledge about prostate cancer and experiences working with men with prostate cancer and their families. Participants can also receive professional support by scheduling monthly virtual meetings (and additional meetings as needed) with the educator, either online or via a computer-assisted telephone call. At the meetings, which last 15–30 min, the educator helps couples review their symptoms and management, identifies goals to achieve, reviews the online modules if needed, troubleshoots any technical problems, and encourages couples to use the different components of the PERC program. These meetings consist of PERC orientation (week 1), completion of modules (weeks 2–14), and the final session (week 15).

Criteria for discontinuing or modifying allocated interventions {11b}

Patients and their partners will become ineligible for further participation in this study if either or both receives a diagnosis of any type of cancer (e.g., breast, bowel) except for non-melanomatous skin cancer or develops a condition that prevents them from fully participating in study activities such as scheduling and completing surveys or online or computer-assisted telephone call with the nurse educator. Participants will also be removed from the study if they decide to withdraw from the study voluntarily.

Strategies to improve adherence to interventions {11c}

We follow fidelity guidelines for health behavior research recommended by the NIH Behaviour Change Consortium [46] and recommendations to ensure fidelity for mHealth interventions [47].

Training

Before initiating PERC, we trained the nurse educator about the program, the PERC website, and process monitoring, using a standardized protocol checklist developed and refined in our pilot studies.

PERC implementation

Use of mHealth technology ensures that PERC is presented consistently. The nurse educator documents their intervention activities in the administrative log and records their online meetings with participants. The PI and project coordinator meets with the nurse educator to review fidelity issues and to provide feedback and demonstrations; these meetings occur weekly or whenever any member of the research team notices a discrepancy between the educator’s activity and the protocol.

PERC receipt

Our built-in Web activity tracking system assesses and records participant use of PERC. Participants who fail to enter the website are reminded via email, phone, or text messages. PERC was designed to minimize complexity by using plain language, using a low reading level, and implementing simple website navigation.

PERC enactment

The research team provides technical support to help address and document any issues that prevent participants’ use of PERC website.

Relevant concomitant care permitted or prohibited during the trial {11d}

Participants are informed that this supportive care intervention does not interfere with their clinical care for cancer and/or other comorbid conditions. We anticipate that this is a minimal risk study. The PERC and NCI websites provide state-of-science resources that participants can use at their convenience. We will also refer them to their treating clinicians should any serious adverse medical or psychological event happen. No post-trial care is needed.

Provisions for post-trial care {30}

There is no anticipated harm and compensation for trial participation. However, we plan to refine the intervention and/or develop new programs to address any care needs reflected through participants’ comments and feedback during the trial.

Outcomes {12}

Primary outcomes include QOL total and subdomain scores. We use the 27-item Functional Assessment of Chronic Illness Therapy General Scale (FACT-G) to measure cancer-related QOL [48] and the physical, social, emotional, and functional domains of QOL [49]. Partners report their own cancer-related QOL using the partner’s version of FACT-G with modified wording [50].

Secondary outcomes include appraisal and coping resources. Appraisals of illness—patients’ and partners’ perceptions of the degree of threat associated with prostate cancer and related symptoms—are measured using a 20-item version of the Appraisal Scales, abstracted from the 32-item patient version and the 27-item caregiver versions of the measure [51]. Responses are provided on a 5-point Likert response scale [51, 52].

Self-efficacy is assessed by a 9-item modified version of the Lewis Cancer Self-Efficacy Scale, which measures confidence in managing prostate cancer symptoms. Responses are provided on a 10-point Likert scale. The partner version of the scale [53] evaluates partners’ confidence in their own ability to manage prostate cancer symptoms.

Social support is assessed using the PROMIS Emotional, Informational, and Instrumental Support Measures [54,55,56] and the appraisal support subscale of the Social Support Questionnaire [57].

For healthy behaviors, overall diet quality is assessed using the Dietary Risk Assessment (DRA) which is a brief food frequency dietary assessment [58]. Physical activity is assessed using the Measure of Older Adults’ Sedentary Time (MOST) [59, 60] which includes time spent in sedentary behaviors such as watching TV, computer use, reading, transport and hobbies, and total sedentary time.

Symptom outcomes. Prostate cancer-specific symptoms are measured using the Prostate Cancer Index Composite (EPIC-26) [61]. For patients, we will calculate [61] EPIC’s urinary irritability, urinary incontinence, bowel, sexual, and hormonal subscale scores. The partners complete a 4-item EPIC (spousal version), which assesses how much of a problem the patients’ bowel, hormonal, sexual, or urinary symptoms were for the partner.

General symptoms. Patients and partners separately rate their own symptoms of pain, fatigue, sleep disturbance [62,63,64,65], cancer anxiety [66], and depression [67] using the PROMIS measures.

Participant timeline {13}

After informed consent and baseline assessments (T1, which occurs after completion of surgery or radiation), enrolled patient-partner couples are randomly assigned to PERC or enhanced usual care (usual care plus the NCI website) groups. After an intervention period that lasts approximately 15 weeks, participants complete three surveys to assess the short, intermediate, and long-term effects of PERC: at 4 months post-T1 (T2), 8 months post-T1 (T3), and 12 months post-T1 (T4).

Sample size {14}

We planned to enroll 250 patient-partner couples to achieve the study objectives. We calculated power for comparing our primary outcome (total QOL) using a standard approach for linear mixed models [68]. Because we will assess outcomes for patients and partners separately, we applied a Bonferroni-corrected, two-sided alpha of 0.025 to allow for separate overall tests for patients and partners [68]. Although dyadic data will be modeled simultaneously, this correction allows for the possibility that conclusions may differ for patients and partners. Based on our pilot test of PERC [35], we assumed a common standard deviation for the total QOL scores of 15 points and a within-person correlation between repeated measurements of 0.75. Also, we allowed for losing up to 7% of participants every 4 months, for a total attrition of 20% through 12 months.

Recruitment {15}

After receiving weekly reports of localized prostate cancer patients from North Carolina Central Cancer Registry Rapid Case Ascertainment (RCA), we contact patients’ physicians by letter and give them 2 weeks to request that a patient not be approached for study inclusion. After the 2-week window, we start to recruit using the procedure outlined above in the informed consent section.

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