Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996031
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Vignet, Inc.
Information provided by (Responsible Party):
Sofia Garcia, Northwestern University

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].

Condition or disease Intervention/treatment
Cancer, Breast Cancer of Colon Cancer of Rectum Cancer Device: Plan to Thrive smartphone application

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic Using a Smartphone-enabled Monitoring, Navigation and Tailored Intervention Program
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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 Outcome Measures :
  1. Symptom burden [ Time Frame: 4 months (baseline to follow-up). ]
    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.

  2. Health-related quality of life (HRQoL) [ Time Frame: 4 months (baseline to follow-up). ]
    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).

  3. Patient satisfaction [ Time Frame: 4 months (baseline to follow-up). ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult survivors of cancer (e.g., breast, colorectal), who have completed their primary cancer treatment.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996031


Contacts
Layout table for location contacts
Contact: Sofia F Garcia, Ph.D. 312-503-3449 sofia-garcia@northwestern.edu
Contact: Elizabeth Addington, Ph.D. 312-503-3808 elizabeth.addington@northwestern.edu

Locations
Layout table for location information
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Sofia Garcia, Ph.D.         
Sponsors and Collaborators
Northwestern University
Vignet, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Sofia F Garcia, Ph.D. Northwestern University
Layout table for additonal information
Responsible Party: Sofia Garcia, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03996031    
Other Study ID Numbers: STU00209558
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases