Trial Outcomes & Findings for Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program (NCT NCT04350788)
NCT ID: NCT04350788
Last Updated: 2020-09-23
Results Overview
Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
after participants completed baseline survey
Results posted on
2020-09-23
Participant Flow
Unit of analysis: dyad
Participant milestones
| Measure |
Survivorship Care Plan (SCP)
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
|
Enhanced SCP (ESCP)
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
|
|---|---|---|
|
Overall Study
STARTED
|
62 31
|
62 31
|
|
Overall Study
COMPLETED
|
50 25
|
56 28
|
|
Overall Study
NOT COMPLETED
|
12 6
|
6 3
|
Reasons for withdrawal
| Measure |
Survivorship Care Plan (SCP)
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
|
Enhanced SCP (ESCP)
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Protocol Violation
|
4
|
0
|
Baseline Characteristics
Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using A Couple-focused Web-based Tailored Symptom Self-management Program
Baseline characteristics by cohort
| Measure |
Survivorship Care Plan (SCP)
n=31 dyad
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
|
Enhanced SCP (ESCP)
n=31 dyad
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
|
Total
n=62 dyad
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.63 years
STANDARD_DEVIATION 7.37 • n=5 Participants
|
62.62 years
STANDARD_DEVIATION 8.13 • n=7 Participants
|
63.12 years
STANDARD_DEVIATION 7.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Less than college
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Education
Bachelor's Degree
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Education
Graduate Degree (Master's PhD, JD, MD, etc.)
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Employment Status
Yes
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Employment Status
No
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Income
<= $60,000
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Income
>$60,000
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Income
Don't know/refused
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Type of Treatment
Radiation
|
16 dyad
n=31 dyad
|
17 dyad
n=31 dyad
|
33 dyad
n=62 dyad
|
|
Type of Treatment
Surgery
|
15 dyad
n=31 dyad
|
14 dyad
n=31 dyad
|
29 dyad
n=62 dyad
|
|
Charlson comorbidity index
|
3.85 score on a scale
STANDARD_DEVIATION 1.76 • n=5 Participants
|
4.21 score on a scale
STANDARD_DEVIATION 2.18 • n=7 Participants
|
4.03 score on a scale
STANDARD_DEVIATION 1.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: after participants completed baseline surveyPopulation: 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.
Will evaluate the percentage of patients and partners successfully consented and completing the baseline survey among all people approached for the study
Outcome measures
| Measure |
Overall
n=149 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Percentage of Potentially Eligible Participants Actually Enrolled Into the Study
|
62 dyad
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: during 4-month study periodWill 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).
Outcome measures
| Measure |
Overall
n=31 dyad
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=31 dyad
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Percentage of Participants Enrolled Who Remained in the Study and Completed the Post-Intervention Follow-Up Survey
|
25 dyad
|
28 dyad
|
—
|
—
|
PRIMARY outcome
Timeframe: during 4-month study periodPopulation: We don't have information about web pages that participants reviewed in control group.
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
Outcome measures
| Measure |
Overall
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=31 dyad
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Percentage of Participants That Used the Web-Based Intervention Sessions That Are Consistent With Patient-Reported Symptoms
|
—
|
13 dyad
|
—
|
—
|
PRIMARY outcome
Timeframe: at the 4 month followupPopulation: 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).
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
Outcome measures
| Measure |
Overall
n=31 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=31 Participants
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
|
Survivorship Care Plan (SCP): Partner
n=31 Participants
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
|
Enhanced SCP (ESCP): Partner
n=31 Participants
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
|
|---|---|---|---|---|
|
Participant Satisfaction Scores
|
30.48 score on a scale
Standard Deviation 11.47
|
36.30 score on a scale
Standard Deviation 8.11
|
36.29 score on a scale
Standard Deviation 13.54
|
38.59 score on a scale
Standard Deviation 10.34
|
PRIMARY outcome
Timeframe: at the 4 month followupPopulation: 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.
Outcome measures
| Measure |
Overall
n=31 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=31 Participants
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
|
Survivorship Care Plan (SCP): Partner
n=31 Participants
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
|
Enhanced SCP (ESCP): Partner
n=31 Participants
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
|
|---|---|---|---|---|
|
Perceived Ease of Use Score
Content
|
17.11 score on a scale
Standard Deviation 2.37
|
17.32 score on a scale
Standard Deviation 1.99
|
16.83 score on a scale
Standard Deviation 2.26
|
16.55 score on a scale
Standard Deviation 2.21
|
|
Perceived Ease of Use Score
Navigation
|
33.89 score on a scale
Standard Deviation 5.26
|
36.84 score on a scale
Standard Deviation 3.93
|
34.79 score on a scale
Standard Deviation 4.80
|
35.02 score on a scale
Standard Deviation 5.66
|
|
Perceived Ease of Use Score
General
|
12.44 score on a scale
Standard Deviation 1.58
|
12.60 score on a scale
Standard Deviation 1.29
|
12.68 score on a scale
Standard Deviation 1.53
|
12.53 score on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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.
Outcome measures
| Measure |
Overall
n=62 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=62 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Change in FACT-G Scores
|
-0.03 score on a scale
Standard Deviation 8.98
|
1.91 score on a scale
Standard Deviation 8.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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.
Outcome measures
| Measure |
Overall
n=31 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=31 Participants
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
|
Survivorship Care Plan (SCP): Partner
n=31 Participants
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
|
Enhanced SCP (ESCP): Partner
n=31 Participants
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
|
|---|---|---|---|---|
|
Change in Appraisal of Prostate Cancer-Specific Symptoms
Urinary
|
11.03 score on a scale
Standard Deviation 16.91
|
19.58 score on a scale
Standard Deviation 23.02
|
-0.48 score on a scale
Standard Deviation 0.87
|
-0.46 score on a scale
Standard Deviation 1.75
|
|
Change in Appraisal of Prostate Cancer-Specific Symptoms
Bowel
|
2.31 score on a scale
Standard Deviation 8.83
|
6.93 score on a scale
Standard Deviation 20.17
|
-0.2 score on a scale
Standard Deviation 1.00
|
-0.11 score on a scale
Standard Deviation 1.10
|
|
Change in Appraisal of Prostate Cancer-Specific Symptoms
Sexual
|
1.46 score on a scale
Standard Deviation 21.01
|
7.45 score on a scale
Standard Deviation 22.54
|
0.04 score on a scale
Standard Deviation 1.40
|
0.32 score on a scale
Standard Deviation 1.31
|
|
Change in Appraisal of Prostate Cancer-Specific Symptoms
Hormonal
|
1.99 score on a scale
Standard Deviation 17.48
|
4.61 score on a scale
Standard Deviation 15.81
|
-0.04 score on a scale
Standard Deviation 1.21
|
-0.21 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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 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.
Outcome measures
| Measure |
Overall
n=31 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=31 Participants
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
|
Survivorship Care Plan (SCP): Partner
n=31 Participants
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
|
Enhanced SCP (ESCP): Partner
n=31 Participants
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
|
|---|---|---|---|---|
|
Change in Appraisal of General Symptoms
|
-1.26 score on a scale
Standard Deviation 4.21
|
-2.97 score on a scale
Standard Deviation 5.26
|
-0.59 score on a scale
Standard Deviation 4.26
|
-1.35 score on a scale
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: during the first 10 months after participants completed baseline surveyPopulation: 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.
The total number of prostate cancer-related followup visits, emergency room use and readmissions.
Outcome measures
| Measure |
Overall
n=31 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=31 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Healthcare Utilization Extracted From Electronic Medical Record
|
4.84 number of visits
Standard Deviation 4.68
|
4.65 number of visits
Standard Deviation 4.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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.
Outcome measures
| Measure |
Overall
n=62 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=62 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Change in Self-Efficacy Scores From Baseline to 4-Months Post Baseline
|
-1.40 score on a scale
Standard Deviation 6.81
|
0.50 score on a scale
Standard Deviation 5.58
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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.
Outcome measures
| Measure |
Overall
n=62 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=62 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Change in PROMIS Social Support-Informational Support From Baseline to 4-Months Post-Baseline
|
-0.09 score on a scale
Standard Deviation 8.81
|
0.98 score on a scale
Standard Deviation 6.24
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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.
Outcome measures
| Measure |
Overall
n=62 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=62 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Change in PROMIS Social Support-Emotional Support From Baseline to 4-months Post-Baseline
|
0.02 score on a scale
Standard Deviation 6.74
|
0.29 score on a scale
Standard Deviation 5.93
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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.
Outcome measures
| Measure |
Overall
n=62 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=62 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Change in PROMIS Social Support-Instrumental Support From Baseline to 4-months Post-Baseline
|
-0.76 score on a scale
Standard Deviation 6.59
|
-0.21 score on a scale
Standard Deviation 5.76
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: Intention-to-treat.
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.
Outcome measures
| Measure |
Overall
n=62 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=62 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Change in Dietary Risk Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
|
-0.10 score on a scale
Standard Deviation 0.43
|
-0.10 score on a scale
Standard Deviation 0.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline upon enrollment, Month 4Population: 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.
Outcome measures
| Measure |
Overall
n=62 Participants
Enrollment rate is calculated before randomization without arms.
|
Enhanced SCP (ESCP)
n=62 Participants
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
|
Survivorship Care Plan (SCP): Partner
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
|
Enhanced SCP (ESCP): Partner
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
|
|---|---|---|---|---|
|
Change in Physical Activity Assessment Scores From Baseline to 4-month Post Baseline as Measured by the Health Promoting Lifestyle Profile II
|
-0.02 score on a scale
Standard Deviation 0.51
|
-0.01 score on a scale
Standard Deviation 0.49
|
—
|
—
|
Adverse Events
Survivorship Care Plan (SCP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced SCP (ESCP)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Survivorship Care Plan (SCP)
n=62 participants at risk
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
|
Enhanced SCP (ESCP)
n=62 participants at risk
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
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
restarting cancer treatment
|
0.00%
0/62 • 2 years from the beginning of the study recruitment to the end of data collection.
No death happened during the study period, and thus, the All-Cause Mortality is zero
|
1.6%
1/62 • Number of events 1 • 2 years from the beginning of the study recruitment to the end of data collection.
No death happened during the study period, and thus, the All-Cause Mortality is zero
|
|
Cardiac disorders
Severe health problem
|
0.00%
0/62 • 2 years from the beginning of the study recruitment to the end of data collection.
No death happened during the study period, and thus, the All-Cause Mortality is zero
|
1.6%
1/62 • Number of events 1 • 2 years from the beginning of the study recruitment to the end of data collection.
No death happened during the study period, and thus, the All-Cause Mortality is zero
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place