Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.

Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment

This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Gynecologic Cancer; Lung Cancer
• Intervention / Treatment: Other: Carevive PROmpt™

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Mitchell Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All participants must be 18 years of age or older.
• Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer.
• Patients must have completed their navigation visit and received a Treatment Care Plan.
• Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
• Subjects must be starting or receiving treatment.
• All participants must be able to understand English.

Exclusion Criteria:

• Any patient who cannot understand written or spoken English.
• Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
• Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.	Aim 1 is to compare treatment side effect frequency and intensity and patient treatment adherence between Intervention and Control subjects. Data collection for this Aim includes side effect frequency and intensity and time on treatment. Patients in the intervention arm will complete the Core Assessment prior to enrollment as standard of care. They will be enrolled to use the Carevive PROmpt™ platform to access from home. Patients will be instructed to report symptoms once a week between clinic visits. Outcomes measures for this Aim are the prevalence and severity of symptoms in each group, adherence to symptom reporting from home in intervention participants, and time on treatment from enrollment to 3 months after enrollment. Prevalence will be determined by the number of symptom alerts per patient over 3 months/ Severity will be determined by the number of mild, moderate, severe, and very severe over 3 months.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes for Secondary Aim 2 - 50 intervention patients will complete the Patient Satisfaction Survey at the 3month timepoint to measure satisfaction with treatment decision and care experience.	Aim 2 is to describe patient satisfaction with care experience and satisfaction with treatment decision. Patient satisfaction with care experience and satisfaction with treatment decision will be measured with the Patient Satisfaction Survey (Appendix E). This survey is derived from the Survey of Patient Experiences with Cancer Care Survey (i.e., the Cancer CAHPS) which was developed specifically for cancer patients and is used to evaluate satisfaction with care in the Oncology Care Model (OCM). Surveys will be completed by intervention patients at the three months visit (by paper or electronically) or from home (electronically or by phone administered by the RC) if no visit is planned.	10 months
Outcomes for Secondary Aim 3 - Feasibility will be measured by completion of the patient questionnaires and patient symptom reports by the 50 intervention patients. Usability will be measured through provider feedback.	Aim 3 is to determine feasibility/usability of the electronic treatment planning and symptom assessment for the intervention arm only. Feasibility will be determined by the number of patients enrolled compared to the number of patients approached, and of those declined the reasons for the decline. Usability will be determined by the results of the patient satisfaction survey.	10 months

Collaborators and Investigators

• Sponsor: Carevive Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): October 7, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: G423 Multi TP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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