Cancer, BreastPTTNCT03996031
Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic
An observational study of Cancer, Breast and Cancer of Colon, run by Northwestern University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast, Cancer of Colon, Cancer of Rectum
- What is being tested?
- Plan to Thrive smartphone application
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult survivors of cancer (e.g., breast, colorectal), who have completed their primary cancer treatment.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
About this study
Official title: 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].
- Conditions
- Cancer, Breast, Cancer of Colon, Cancer of Rectum, Cancer
- Being tested
- Plan to Thrive smartphone application
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plan to Thrive smartphone applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Plan to Thrive smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 4 months (baseline to follow-up).
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: 4 months (baseline to follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start19 Aug 2019
- Primary completion23 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Vignet, Inc.
- Responsible party
- Principal investigator, Sofia Garcia, Northwestern University
- Investigators
- Sofia F Garcia, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996031
- Sponsor's protocol ID
- STU00209558
- Acronym
- PTT
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plan to Thrive: Extending Cancer Survivorship Care Beyond the Clinic Using a Smartphone-enabled Monitoring, Navigation and Tailored Intervention Program
- ClinicalTrials.gov ID
- NCT03996031
- Acronym / sponsor ID
- PTT / STU00209558
- Conditions
- Cancer, Breast, Cancer of Colon, Cancer of Rectum, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Vignet, Inc.
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Sample | – | Device: Plan to Thrive smartphone applicationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult survivors of cancer (e.g., breast, colorectal), who have completed their primary cancer treatment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plan to Thrive smartphone applicationAll 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. | Device | Study Sample |
Primary outcome
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).
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).
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).
3 secondary outcomes
Symptom burden
Time frame: 4 months (baseline to follow-up).
Health-related quality of life (HRQoL)
Time frame: 4 months (baseline to follow-up).
Patient satisfaction
Time frame: 4 months (baseline to follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia F Garcia, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Breast and Cancer of Colon, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of enrollment (time frame: 4 months (baseline to follow-up)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.