Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.

NCT04772118 | Completed

• 1 other identifier: G423 Multi TP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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™.

Conditions

Lung Cancer; Breast Cancer; Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  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.

  10 months

Interventions

Carevive PROmpt™ OTHER

Patient Reported Outcomes Mobile Patient (Carevive PROmpt™), a digital cancer symptom monitoring platform.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Carevive Systems, Inc.: lead

Study Sites (1)

Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 26, 2021
• Study Start: February 16, 2021
• Primary Completion: October 7, 2021
• Study Completion: November 1, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)