An interventional study of Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) in Colorectal Cancer, Bladder Cancer and Ovarian Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 46 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 424 studies on the registry; 96 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must:
Caregivers must:
Exclusion Criteria:
Patients and their caregivers will be excluded if they:
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 assigned to this arm will receive the standard of care that is provided to all patients.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2-month followup survey
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 months
Participants were enrolled in the study between 11/02/2020 - 8/10/2021 at one cancer center in North Carolina.
| Milestone | Usual Care | Caregiver-Usual Care | PRISMS | Caregiver-PRISMS |
|---|---|---|---|---|
| Started | 7 | 7 | 16 | 16 |
| Completed | 5 | 5 | 12 | 12 |
| Not completed | 2 | 2 | 4 | 4 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 | 2 |
| Withdrew: Protocol violation | 1 | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 |
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 dyad participants | Potentially Eligible Dyads Recruited Into The Study |
|---|---|
| Enrollment Number | 25 |
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 dyad participants | Percentage of Potentially Eligible Participants Recruited Into The Study |
|---|---|
| Number of Potentially Eligible Dyads Participants Actually Enrolled in the Study | 23 |
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.
| Number of dyad participants | Potentially Eligible Participants Recruited Into The Study |
|---|---|
| Number of Dyads Remained in the Study and Completed the Post-Intervention Follow-Up Survey. | 17 |
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.
| score on a scale | Usual Care Patient | Usual Care- Caregivers | PRISMS Patients | PRISMS- Caregivers |
|---|---|---|---|---|
| general aspect | 17.00 ± 3.65 | 17.50 ± 2.07 | 20 ± 3.66 | 20.36 ± 3.20 |
| content aspect | 19.75 ± 4.99 | 18.50 ± 3.11 | 20.71 ± 3.41 | 21.36 ± 3.83 |
| navigation aspect | 35.69 ± 7.46 | 37.45 ± 7.24 | 38.16 ± 6.37 | 30.75 ± 1.89 |
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.
| score on a scale | Usual Care | Usual Care- Caregivers | PRISMS | PRISMS -Caregivers |
|---|---|---|---|---|
| Q1 | 3.20 ± 1.10 | 3.20 ± 1.48 | 4.08 ± 0.79 | 3.83 ± 0.72 |
| Q2 | 3.60 ± 1.34 | 4.20 ± 0.84 | 4.08 ± 1.00 | 4 ± 0.95 |
| Q3 | 3.40 ± 1.14 | 4.00 ± 1.00 | 4.00 ± 0.95 | 3.92 ± 0.90 |
| Q4 | 3.60 ± 0.89 | 4.20 ± 1.1 | 4.08 ± 1.00 | 4 ± 0.85 |
| Q5 | 3.80 ± 1.10 | 3.60 ± 1.14 | 4.08 ± 1.00 | 4.17 ± 0.72 |
| Q6 | 3.60 ± 0.89 | 3.40 ± 1.52 | 3.75 ± 1.22 | 4.17 ± 0.72 |
| Q7 | 3.40 ± 0.89 | 3.60 ± 1.14 | 3.17 ± 1.40 | 4.00 ± 0.95 |
| Q8 | 3.20 ± 1.48 | 2.40 ± 1.14 | 3.83 ± 1.19 | 3.64 ± 1.12 |
| Q9 | 3.80 ± 0.84 | 3.60 ± 1.67 | 3.64 ± 1.29 | 3.92 ± 0.79 |
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.
| score on a scale | Usual Care | Usual Care- Caregivers | PRISMS | PRISMS- Caregivers |
|---|---|---|---|---|
| Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G). | 18.43 ± 13.59 | 13.57 ± 33.64 | 7.41 ± 8.98 | 9.53 ± 13.86 |
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.
| score on a scale | Usual Care | Usual Care- Caregivers | PRISMS | PRISMS - Caregivers |
|---|---|---|---|---|
| Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a | 6.56 ± 1.55 | 10.02 ± 8.48 | 13.42 ± 3.59 | 13.22 ± 3.62 |
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.
| score on a scale | Usual Care | PRISMS |
|---|---|---|
| Patients | 14.77 ± 8.83 | 8.55 ± 4.76 |
| Patients' caregiver | 20.94 ± 5.60 | 11.08 ± 1.63 |
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.
| score on a scale | Usual Care | Usual Care- Caregivers | PRISMS | PRISMS -Caregivers |
|---|---|---|---|---|
| Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b | 7.28 ± 13.00 | 24.85 ± 5.28 | 13.02 ± 2.39 | 7.72 ± 15.60 |
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.
| score on a scale | Usual Care | Usual Care- Caregivers | PRISMS | PRISMS - Caregivers |
|---|---|---|---|---|
| Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a | 8.73 ± 29.94 | 46.19 ± 6.18 | 10.86 ± 7.48 | 16.28 ± 5.76 |
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.
| score on a scale | Usual Care | PRISMS |
|---|---|---|
| Change in Sleep Among Caregivers. | 16.49 ± 29.84 | 0.40 ± 11.15 |
Collected over Not available, Adverse Events were not collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | — | — | — |
| Caregiver-Usual Care | — | — | — |
| PRISMS | — | — | — |
| Caregiver-PRISMS | — | — | — |
Subjects started to study interventions.
| Age, Continuous(years) | Usual Care | Caregiver-Usual Care | PRISMS | Caregiver-PRISMS | Total |
|---|---|---|---|---|---|
| Mean | 57.71 ± 25.81 | 38.00 ± 27.47 | 56.81 ± 13.73 | 48.06 ± 16.30 | 51.04 ± 19.72 |
| Sex: Female, Male(Participants) | Usual Care | Caregiver-Usual Care | PRISMS | Caregiver-PRISMS | Total |
|---|---|---|---|---|---|
| Female | 2 | 7 | 4 | 11 | 24 |
| Male | 5 | 0 | 12 | 5 | 22 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care | Caregiver-Usual Care | PRISMS | Caregiver-PRISMS | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 7 | 16 | 16 | 46 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Care | Caregiver-Usual Care | PRISMS | Caregiver-PRISMS | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 2 | 2 | 8 |
| White | 5 | 5 | 12 | 13 | 35 |
| More than one race | 0 | 0 | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Usual Care | Caregiver-Usual Care | PRISMS | Caregiver-PRISMS | Total |
|---|---|---|---|---|---|
| United States | 7 | 7 | 16 | 16 | 46 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
Ran from Nov 2020 to primary completion in Oct 2021, 11 months.
Results were first posted in Feb 2025, 3 years 3 months after primary completion.
Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 11 months is below that.
Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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