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

Primary Purpose

Colorectal Cancer, Bladder Cancer, Ovarian Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring ostomy (colostomy, urostomy, and ileostomy), symptom, self-management, caregiving, family research, telehealth, self-efficacy, quality of life, post-treatment care transition

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRISMS

Usual Care

Arm Description

In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.

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

Outcomes

Primary Outcome Measures

Recruitment rate

Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study

Enrollment rate

Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.

Retention rate

Retention rate will be assessed by the percentage of enrolled participants who have completed the 2-month followup survey at the end of the study period.

Satisfaction with the PRISMS program

Satisfaction with the PRISMS program will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.

Perceived ease of use of the PRISMS program

Perceived ease of use of the PRISMS program will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.

Secondary Outcome Measures

Change of Quality of Life (QOL)

Quality of Life (QoL) will be assessed 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 in the FACT-G scores from T1 (baseline survey) to T2 (2-month followup survey) will be calculated.

Healthcare Utilization Extracted From Electronic Medical Record

The total number of ostomy-related followup visits, emergency room use and re-admissions.

Full Information

NCT ID

NCT04492007

First Posted

June 24, 2020

Last Updated

August 29, 2022

Sponsor

UNC Lineberger Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04492007

Brief Title

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

Acronym

PRISMS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

October 21, 2021 (Actual)

Study Completion Date

December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRISMS

Arm Type

Experimental

Arm Description

In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Recruitment rate

Description

Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study

Time Frame

from study launching to completion

Title

Enrollment rate

Description

Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.

Time Frame

after T1 (baseline survey)

Title

Retention rate

Description

Retention rate will be assessed by the percentage of enrolled participants who have completed the 2-month followup survey at the end of the study period.

Time Frame

after T2 (2-month followup survey)

Title

Satisfaction with the PRISMS program

Description

Time Frame

after T2 (2-month followup survey)

Title

Perceived ease of use of the PRISMS program

Description

Time Frame

after T2 (2-month followup survey)

Secondary Outcome Measure Information:

Title

Change of Quality of Life (QOL)

Description

Time Frame

T1 (baseline survey) and T2 (2-month followup survey)

Title

Healthcare Utilization Extracted From Electronic Medical Record

Description

The total number of ostomy-related followup visits, emergency room use and re-admissions.

Time Frame

90 days past T1 (baseline survey)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lixin Song, RN, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

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

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