Skip to main content
OpenTrials
Completed

NCT Number: NCT04772118

Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.

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™.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Carevive PROmpt™

Other

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

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.

    Time frame: 10 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.

Secondary outcomes

  1. 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.

    Time frame: 10 months

    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.

  2. 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.

    Time frame: 10 months

    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.

Sponsors and collaborators

Lead sponsor

Carevive Systems, Inc.

Industry

Registry information

Official study title

Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.