Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS) (PRISMS)

This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Colorectal Cancer; Ovarian Cancer; Bladder Cancer; Uterine Cancer
• Intervention / Treatment: Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)

Detailed Description

In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients must:

• have been surgically treated for colorectal, bladder, ovarian, cervical, or uterine cancer with curative intent;
• be within one month of hospital discharge of a newly created ostomy with curative intent;
• be able to read and speak English;
• be 18 years or older;
• have a caregiver who is willing to participate in the study;

Caregivers must:

• be 18 years or older;
• be able to read and speak English;
• be identified as the primary caregiver by the patient;
• have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).

Exclusion Criteria:

Patients and their caregivers will be excluded if they:

• are unable to read, speak, or understand English;
• have more than one type of ostomy;
• have other cancer diagnosis (excluding non-melanomatous skin cancer); or
• have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants assigned to this arm will receive the standard of care that is provided to all patients.
Experimental: PRISMS; In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.	Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS); Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Number	The enrollment rate is defined as the number of potentially eligible couples (dyads) who have consented to participate in the study. 1 Dyad = 1 participant + their caregiver. Potentially eligible dyads (subjects and their caregivers) were approached and informed about the study. then the number of dyads who consented and completed.	Baseline
Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study	Potentially Eligible Dyads Participants Actually Enrolled in the Study will be evaluated by the number of dyads who successfully consented and completed the baseline survey among all people approached for the study. 1 Dyad = 1 participant + their caregiver.	Baseline, after consent
Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey.	The number of dyad Participants Enrolled who Remained in the Study and Completed the Post-Intervention Follow-Up Survey was assessed by the number of enrolled dyad participants who completed the 2-month follow-up survey at the end of the study period.	Up to 3 months (2-month follow up survey)
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS)	Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS) evaluates three aspects: General, content, and navigation, contains 19 items on a 5-point Likert scale, where 1 is "strongly disagree" and 5 is "strongly agree". The score for each aspect was calculated as the sum of the scores from all items in this aspect. The scores ranged between 5 and 25 for General and Content, and the Navigation score ranged between 9 and 45. The higher score of the specific aspect that patients and their caregivers reported indicates the better usability of the aspect. This survey was offered separately at the follow-up visit to patients and their caregivers. Participants who completed at least 80.00% of the questions were included in the analysis. Usual Care and Informed Symptom Management System (PRISMS) group scores were compared.	Up to 2 months (Follow up survey)
Satisfaction With the PRISMS Program	The satisfaction survey evaluates satisfaction with various aspects, contains 9 items on a 5-point Likert scale of 1 to 5, and higher scores reflect better satisfaction. Questions: Q1. The amount of time to review the program every time. Q2. Ease of navigating. Q3. Information I received. Q4. Quality of the information I received. Q5. The program has increased my knowledge about managing my symptoms and complications. Q6. The program has improved how I manage my symptoms and complications. Q7. The program has improved how I communicate with my family about sensitive topics related to my cancer care. Q8. The time and effort took me to complete. Q9. My knowledge about how my cancer has affected my partner and our relationship was improved. This survey was offered at the follow-up visit to patients and their caregivers separately. More than 80.00% of the questions answered were included in the analysis. The mean score for each question for Usual Care and PRISMS were compared.	2-month followup survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G).	Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G) at baseline and follow-up visit to patients and their caregivers separately. Change from baseline is the post-baseline value minus the Baseline value. FACT-G is a 27-item survey that assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. The total FACT-G score is calculated as the sum of four sub-scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time Mean FACT-G difference between baseline and 2 months were presented.	baseline , 2 months
Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a	Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a used to examine the change in anxiety among patients and their caregivers separately, from Baseline to follow up (2 months). For all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 36.3 to 82.7 with higher scores reflect higher anxiety.	Baseline and 2 months
Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b	Change of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b will be assessed by PROMIS-Emotional Distress-Depression Short From 8b. It is used to measure the change in depression scores among patients and their partners from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 24.7 to 63.5 with higher scores indicate greater depressive symptoms.	Baseline, 2 months
Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b	Change Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b will be assessed by PROMIS Pain Interference - Short Form 6b. It is used to measure the change in Pain. It was offered to patients and their caregivers separately. Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The pain measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference. The score value ranges between 41-78.3.	Baseline, 2 months
Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a	PROMIS Fatigue -Short Form 7a is used to measure the change in Fatigue among patients and their caregivers separately, from Baseline (T1) to T2 (2 months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The fatigue scale measures the extent to which patients and their partners experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. Score value ranges between 29.4 - 83.2.	Baseline, 2 months
Change in Sleep Among Caregivers.	Change in Sleep among caregivers. was assessed by the 22-item version of the Zarit Burden Interview is a caregiver self-reported instrument. It is used to assess caregiving burden change among caregivers from Baseline (T1) to T2 (2 months post-T1). Each item on the interview is a statement that the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores reflect more severe burden, 0-21: no to mild burden; 21-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden. The score value ranges between 0-88.	Baseline, 2 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Lixin Song, RN, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; self-management; caregiving; self-efficacy; telehealth; symptom; family research; ostomy (colostomy, urostomy, and ileostomy); post-treatment care transition
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms
• Other Study ID Numbers: LCCC1929; R01NR016990 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No