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Clinical Trials/NCT03996031
NCT03996031
Completed
Not Applicable

Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic Using a Smartphone-enabled Monitoring, Navigation and Tailored Intervention Program

Northwestern University1 site in 1 country33 target enrollmentAugust 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer, Breast
Sponsor
Northwestern University
Enrollment
33
Locations
1
Primary Endpoint
Rate of app usage
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to test the usability of the Plan To Thrive smartphone application with cancer survivors. This study will involve three visits (baseline, follow-up, and feedback assessments). Between the baseline and follow-up time points, patients will undergo a 90-day period in which they will engage with app content. It is hypothesized that cancer survivors in this study will find the smartphone application, Plan to Thrive, an acceptable and feasible way to access post-treatment information. In addition, the investigators will explore preliminary efficacy by examining changes over time in primary (patient activation, patient knowledge and adherence to follow-up care recommendations and health behaviors) and secondary outcomes [symptom burden, health-related quality of life and patient satisfaction].

Registry
clinicaltrials.gov
Start Date
August 19, 2019
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sofia Garcia

Associate Professor

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of app usage

Time Frame: 4 months (baseline to follow-up).

The investigators will explore the feasibility of the study procedures by examining rates of usage (e.g., number of days participants access Plan to Thrive, percentage of prompts read).

Rate of enrollment

Time Frame: 4 months (baseline to follow-up)

The investigators will explore the feasibility of the study procedures by examining rates of enrollment (defined as the percent of eligible individuals who consent to participate).

Rate of retention

Time Frame: 4 months (baseline to follow-up).

The investigators will explore the feasibility of the study procedures by examining rates of retention (defined as percent of consented participants who complete follow-up measures).

Patient knowledge and adherence to follow-up care recommendations and health behaviors

Time Frame: 4 months (baseline to follow-up).

This outcome will be assessed through a Health Behaviors Measure designed by Dr. Garcia for use in survivorship care planning (SCP) studies. This 14-item measure uses a 5-point Likert response scale. The content corresponds to SCP, NCCN and ACS recommendations for cancer survivorship. The investigators have slightly modified and shortened that measure for the present study to ensure it covers all the survivorship concerns addressed by Plan to Thrive. All patients will complete this measure at T1 and T2, and as part of the Survivor Symptom Update in Plan to Thrive.

Patient activation

Time Frame: 4 months (baseline to follow-up).

Patient activation will be assessed using the "Patient Activation Measure" short form. The 13-item short form of the Patient Activation Measure is a reliable, validated (0-100 point) scale that assesses patient knowledge, skill and confidence for self-management. This will be administered at baseline (T1) and follow-up (T2).

Secondary Outcomes

  • Symptom burden(4 months (baseline to follow-up).)
  • Health-related quality of life (HRQoL)(4 months (baseline to follow-up).)
  • Patient satisfaction(4 months (baseline to follow-up).)

Study Sites (1)

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