Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic (PTT)

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

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].

Study Overview

• Status: Completed
• Conditions: Cancer; Cancer, Breast; Cancer of Colon; Cancer of Rectum
• Intervention / Treatment: Device: Plan to Thrive smartphone application

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Robert H. Lurie Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult survivors of cancer (e.g., breast, colorectal), who have completed their primary cancer treatment.

Description

INCLUSION CRITERIA:

• At least 18 years of age or older
• Prior history of cancer
• Completion of primary cancer treatment (i.e., surgery, chemotherapy and/or radiation; but can be receiving hormonal treatment)
• Have an e-mail account and reliable broadband access to the Internet
• Able to read, understand, and speak English sufficiently to understand study questionnaires and consent form

EXCLUSION CRITERIA:

• Has a medical condition with a life expectancy of fewer than 12 months
• Physical or cognitive disability that would prohibit them from participating in study procedures
• Having prior inpatient psychiatric treatment, or overt signs of, severe psychopathology (e.g., psychosis, substance dependence, suicidality)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Sample; All participants in this single-arm pilot study will receive access to Plan to Thrive. This mobile care management program is comprised of modules including educational interventions, health behavior trackers containing built-in reminders, symptom monitoring, and navigator services (see attached content). Access to intervention modules and individualized navigator services according to patients' needs as captured by 1) their patient-reported outcome (PRO) assessments via Plan to Thrive's symptom monitoring feature, and 2) patient requests. Following the baseline assessment, participants will engage with the Plan to Thrive app for a 90-day period.

Device: Plan to Thrive smartphone application; All participants in this single-arm pilot study will receive access to Plan to Thrive. This mobile care management program is comprised of modules including educational interventions, health behavior trackers containing built-in reminders, symptom monitoring, and navigator services (see attached content). Access to intervention modules and individualized navigator services according to patients' needs as captured by 1) their patient-reported outcome (PRO) assessments via Plan to Thrive's symptom monitoring feature, and 2) patient requests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of enrollment	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).	4 months (baseline to follow-up)
Rate of retention	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).	4 months (baseline to follow-up).
Rate of app usage	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).	4 months (baseline to follow-up).
Patient knowledge and adherence to follow-up care recommendations and health behaviors	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.	4 months (baseline to follow-up).
Patient activation	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).	4 months (baseline to follow-up).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom burden	Symptom burden will be assessed with computer adaptive tests (CATs) from the PROMIS measurement system. PROMIS is an NIH-sponsored system for measuring patient-reported health status, including physical, mental, and social well-being. Participants will complete the PROMIS Anxiety, Depression, Fatigue, and Pain Interference computer adaptive tests (CATs), which administer the minimum number of items necessary to accurately measure patient-reported outcomes while minimizing participant burden. These measures have all demonstrated reliability, precision, and construct validity based on their correlation with legacy instruments. All participants will complete these measures at T1 and T2. In addition, short forms of these PROMIS measures will be used, along with select items (physical activity, nutrition, alcohol use) as part of the Survivor Symptom Update in Plan to Thrive.	4 months (baseline to follow-up).
Health-related quality of life (HRQoL)	HRQoL will be measured with the FACT-G7, administered at baseline (T1) and follow-up (T2). The four-item needs assessment measure was used in prior studies and is based on questions used in a clinical initiative at the RHLCCC, which assess participants' supportive care needs. Items assess in what areas participants need support and service (e.g., coping, managing stress).	4 months (baseline to follow-up).
Patient satisfaction	Patient satisfaction will be assessed using the System Usability Scale (SUS), adminstered at follow-up (T2) only. The System Usability Scale (SUS) is a simple, ten-item scale giving a global view of subjective assessments of usability. This ten-item scale has selected statements that cover a variety of aspects of system usability, such as the need for support, training, and complexity, and thus have a high level of face validity for measuring usability of a system. SUS is a Likert scale, which is based on forced choice questions, where a statement is made and the respondent then indicates the degree of agreement or disagreement with the statement on a 5 point scale. SUS yields a single number representing a composite measure of the overall usability of the system being studied. SUS scores have a range of 0 to 100.	4 months (baseline to follow-up).

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Vignet, Inc.
• Investigators: Principal Investigator: Sofia F Garcia, Ph.D., Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): December 23, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 21, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Breast Neoplasms; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: STU00209558

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