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

NCT04492007 | Completed Results

• 2 other identifiers: LCCC1929R01NR016990
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Bladder Cancer; Ovarian Cancer; Cervical Cancer; Uterine Cancer

Keywords

ostomy (colostomy, urostomy, and ileostomy); symptom; self-management; caregiving; family research; telehealth; self-efficacy; quality of life; post-treatment care transition

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Difference of Quality of Life Change Over Time as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G).

  baseline , 2 months

• Difference of Anxiety Change Over Time as Assessed by PROMIS-Emotional Distress-Anxiety Short Form 7a

  Baseline and 2 months

• Difference of Depression Change Over Time as Assessed by PROMIS-Emotional Distress-Depression Short From 8b

  Baseline, 2 months

• Difference Pain Score Over Time as Assessed by PROMIS Pain Interference - Short Form 6b

  Baseline, 2 months

• Difference of Fatigue Change Over Time as Assessed by PROMIS Fatigue -Short Form 7a

  Baseline, 2 months

Study Arms (2)

PRISMS

EXPERIMENTAL

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)

Usual Care

NO INTERVENTION

Participants assigned to this arm will receive the standard of care that is provided to all patients.

Interventions

Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) BEHAVIORAL

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

PRISMS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Xu S, Tan X, Ma C, McElyea RS, Shieh K, Stover AM, Smith A, Stitzenberg K, Basch E, Song L. An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. BMC Cancer. 2023 Jun 10;23(1):532. doi: 10.1186/s12885-023-10919-x.

  PMID: 37301841 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Urinary Bladder Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Cervical Diseases; Uterine Diseases

Results Point of Contact

• Title: Xianming Tan PhD
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

xianming@email.unc.edu

919-966-8450

Study Officials

• Lixin Song, RN, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 30, 2020
• Study Start: November 2, 2020
• Primary Completion: October 21, 2021
• Study Completion: December 20, 2021
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)