Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),

ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.

Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care

Survivorship Care Plan

In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support

Enhanced Survivorship Care Plan

Lixin Song, RN, PhD

The purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (ESCPs, regular SCPs with the a web-based couple-focused symptom self-management project (PERC) or National Cancer Institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners.

Participation of this study lasts for about for 16 weeks. Depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer.

Eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (SCPs) with the NCI website or the enhanced survivorship care plans (SCP plus the web-based prostate cancer education program, PERC) groups. They complete baseline (T1, prior to randomization) and 4-month post-T1 follow-up measures (T2).

Methods: A two-group randomized controlled pretest-posttest design will be used 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, the investigators 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, the ESCP users will be compared 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 post-treatment care services at T1 and T2. The primary and secondary outcomes are assessed using measurements with sound psychometrical properties. The investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims.

Conclusions: 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.

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

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

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

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).

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

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

UNC Lineberger Comprehensive Cancer Center

No death happened during the study period, and thus, the All-Cause Mortality is zero

The SCP group (control) participants were directed to the National Cancer Institute PC website (NCI) (http://www.cancer.gov/types/prostate),

Survivorship Care Plan: Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care

Survivorship Care Plan (SCP)

ESCP consists of the standard SCP that is enhanced by a couple-focused, tailored mHealth PC education program, the Patient Education Resources for Couples, to improve symptom management at home.

Enhanced Survivorship Care Plan: In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support

Enhanced SCP (ESCP)

Total

Age, Continuous

Sex: Female, Male

White

Black

Other

Race/Ethnicity, Customized

Less than college

Bachelor's Degree

Graduate Degree (Master's PhD, JD, MD, etc.)

Education

Employment Status

<= $60,000

>$60,000

Don't know/refused

the range of household's current annual income

Income

Type of Treatment

Charlson comorbidity index is a weighted scale of comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes. The index range is (0,19). Lower score indicates less severe comorbid condition.

Charlson comorbidity index

Biostatistician

Enrollment rate is calculated before randomization without arms.

Overall

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.

Percentage of Potentially Eligible Participants Actually Enrolled Into the Study

Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey

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

Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms

We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for patient.

We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for partner.

Survivorship Care Plan (SCP): Patient

Enhanced SCP (ESCP): Patient

Survivorship Care Plan (SCP): Partner

Enhanced SCP (ESCP): Partner

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).

Participant Satisfaction Scores

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in general domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in content domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in navigation domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in general domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in content domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in navigation domain.

General

Content

Navigation

Perceived Ease of Use Score

Change in FACT-G Scores

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in urinary domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in bowel domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in sexual domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in hormonal domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in urinary domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in bowel domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in sexual domain.

We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in hormonal domain.

Urinary

Bowel

Sexual

Hormonal

Change in Appraisal of Prostate Cancer-Specific Symptoms

Change in Appraisal of General Symptoms

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.

Spots Global Cancer Trial Database for enhanced survivorship care plan