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

Not Applicable

Completed

Conditions: Cervical Cancer
Ovarian Cancer
Uterine Cancer
Bladder Cancer
Colorectal Cancer

Interventions: Behavioral: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)

Registration Number: NCT04492007

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRISMS	Patient-Reported Outcomes-Informed Symptom Management System (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.

Primary Outcome Measures

Name	Time	Method
Enrollment Number	Baseline	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.
Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study	Baseline, after consent	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.
Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey.	Up to 3 months (2-month 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.
Usability of Reported Outcomes - Patient Reported Outcomes - Informed Symptom Management System (PRISMS)	Up to 2 months (Follow up survey)	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.
Satisfaction With the PRISMS Program	2-month followup survey	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.

Secondary Outcome Measures

Name	Time	Method
Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G).	baseline , 2 months	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.
Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a	Baseline and 2 months	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.
Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b	Baseline, 2 months	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.
Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b	Baseline, 2 months	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.
Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a	Baseline, 2 months	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.
Change in Sleep Among Caregivers.	Baseline, 2 months	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.

Trial Locations

Locations (1): University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States