Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program

Program satisfaction determined by the 11-item Participant Satisfaction Scale measured the level of program satisfaction. The first to tenth items ranged from 1=not satisfied to 5=extremely satisfied. The eleventh item ranged from 1=extremely not to 4=definitely yes. Higher total score indicates greater program satisfaction

Time frame: at the 4 month followup

Population: Intention-to-treat was used in analyses. The sample size was 124 participants (62 patient-partner couples in each group) who completed baseline and were randomized. We analyzed group differences by role (patient vs partner).

The 16-item Program Usability measures participants' assessment of their agreement with the ease of use of the program in terms of its general features, content, and navigation. The ranges of the total scores are (3,15), (4,20), (9,45) for general features, content, and navigation, respectively. The score of individual item ranges from1=strongly disagree to 5=strongly agree. Higher score indicates greater perceived ease of use.

Time frame: at the 4 month followup

Population: Intention-to-treat was used in analyses. The sample size was 124 participants (62 patient-partner couples in each group) who completed baseline and were randomized. We analyzed group differences by role (patient vs partner).

Will evaluate the percentage of participants successfully following protocol, defined as completing the Follow-Up survey at the end of the study period among those who have been enrolled into the study (who completed the baseline).

Time frame: during 4-month study period

The usage of Web-Based Intervention Sessions is determined by the percentage of participants who logged into the study website among those who have been randomly assigned to the intervention group. Patient-Reported Symptoms are determined by patient's responses on their appraisal of prostate cancer symptoms and general symptoms. 1=patient reported the symptom and the symptom webpage reviewed; 0=patient reported the symptom and no related webpage reviewed OR patient did not report the symptom but the webpage reviewed

Time frame: during 4-month study period

Population: We don't have information about web pages that participants reviewed in control group.

Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study

Time frame: after participants completed baseline survey

Population: We excluded 62 of the 211 patients who we approached but did not meet the eligibility criteria. For 149 patients who met study criteria, we asked if they were willing to participant the study. We contacted partners only if patients consented.

The 19-item Risk for Distress-general symptoms is a subscale of the Risk for Distress Scale. It measures how much trouble the participant has with the general symptoms such as pain, fatigue, and etc. The total score ranges between 0 and 38, with higher scores indicating worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat was used in analyses. The sample size was 124 participants (62 patient-partner couples in each group) who completed baseline and were randomized. We analyzed group differences by role (patient vs partner).

The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC will be used to measure change in appraisal of symptoms scores among patients from Baseline (T1) to T2 (4 months post T1). EPIC contains 26 items within 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing opposite results by role: patient with better appraisal of symptoms and partner with worse appraisal of symptoms. Change from baseline is the post-Baseline values minus the Baseline value.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat was used in analyses. The sample size was 124 participants (62 patient-partner couples in each group) who completed baseline and were randomized. We analyzed group differences by role (patient vs partner).

Change in Dietary Risk Assessment scores used to measure changes in dietary risk from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they consume different foods over the past month or week and respond using a Likert Scale ranging from 1=never to 4=routinely. The total score range: 8-32. Higher scores indicate better health behaviors in nutrition.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat.

Change in QOL determined using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change from baseline is the post-Baseline values minus the Baseline value.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat.

Change in Physical Activity Assessment scores used to measure changes in physical activity from Baseline (T1) to T2 (4 months post T1). Change from baseline is the post-Baseline values minus the Baseline value. Participants are asked how often they engage in exercises and physical activity over the past month or week and respond using a Likert Scale, ranging from 1=never to 4=routinely. The total score range: 9-36. Higher scores indicate better health behaviors in physical activity.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat.

The PROMIS Emotional Support System-Short Form 8a will be used to assess changes in the self-reported emotional support system of patients and their partners using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more emotional social support. Change from baseline is the post-Baseline values minus the Baseline value.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a will be used to assess changes in patient and partner reported informational support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more informational support. Change from baseline is the post-Baseline values minus the Baseline value.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat.

The PROMIS Instrumental Support-Short Form 8a will be used to assess changes in patient and partner reported instrumental support system using a 5-point Likert scale from Baseline (T1) to T2 (4 months post T1). The total score range: 8-40. Higher scores indicate more instrumental support. Change from baseline is the post-Baseline values minus the Baseline value.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat.

The Lewis Cancer Self-Efficacy used to measure change in participants' feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1). Participants rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.

Time frame: Baseline upon enrollment, Month 4

Population: Intention-to-treat.

The total number of prostate cancer-related followup visits, emergency room use and readmissions.

Time frame: during the first 10 months after participants completed baseline survey

Population: Intention-to-treat was used in analyses. The overall number of participants analyzed was 62 patients (62 patient-partner couples in each group) who completed baseline and were randomized. Because we would like to analyze the intervention effects on patient's healthcare utilization.