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POSTHOC
Leveraging Technology to Address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC-II): A Phase II Survivorship Care Plan Randomized Controlled Trial
Sponsor study identifier
Secondary identifiers
interventional
51
1 country
1
Study Start
March 5, 2024
Actual (reported)Primary Completion
March 11, 2025
Actual (reported)Study Completion
March 20, 2025
Actual (reported)At the end of cancer treatment, many patients are still dealing with symptoms of cancer and side effects of treatment. Many are also left in a surreal mental state with uncertainty regarding the future of their health. Survivorship Care Plans are plans that are provided to individuals at the completion of cancer treatment (i.e., chemotherapy, surgery, radiation). Survivorship Care Plans describe the details of a person's diagnosis and treatment, as well as provide recommendations for follow-up appointments, referrals, and healthy behaviors to accelerate recovery and prevent recurrence (e.g., diet, exercise, smoking cessation). Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes. Therefore, there is a need to digitize Survivorship Care Plans to improve the accessibility, modifiability, and longevity of the plan. In addition, with current technology, there is an opportunity for Survivorship Care Plans to be linked with mobile devices and activity trackers so that people can track health behaviors and compare them to their clinical goals, enabling people to take charge of their own health. Charles River Analytics developed an app called POSTHOC (POST-treatment Healthcare Outcomes for Cancer survivors) that digitizes the Survivorship Care Plan with goals to integrate it into the digital medical record. Herein, phase I/II feasibility/preliminary efficacy randomized controlled trial is being conducted among 54 patients with cancer who recently completed adjuvant treatment for cancer (e.g., chemotherapy, radiotherapy, surgery) to compare 12 weeks of the POSTHOC app as part of the Survivorship Care Plan vs. the usual care Survivorship Care Plan on total symptom burden. Participants will be randomized 2:1, POSTHOC:usual care. All participants will be asked to download the POSTHOC app to assess technical compatibility and for data collection purposes (i.e., step count via Fitbit, ecological momentary assessment). All participants will have a "lite" version of the app for baseline. Upon randomization, those randomized to the POSTHOC group will be provided with their Survivorship Care Plan via the app, and will choose to focus on nutrition or exercise for the duration of the study, based on their individual plan and personal preferences. These features will also become accessible in the app. At baseline, 6 weeks, and 12 weeks, patient-reported outcomes will be evaluated including total symptom burden, diet, and physical activity. Extensive quantitative and qualitative feedback will also be collected on the usability of the app from those in the POSTHOC arm in order to improve the app for future implementation studies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 20, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 10, 2022
Actual (reported)August 12, 2022
Actual (reported)March 5, 2024
Actual (reported)March 11, 2025
Actual (reported)March 20, 2025
Actual (reported)February 6, 2026
Actual (reported)Number of Participants Who Logged Data at Least Three Times in the POSTHOC App
Number of participants who logged data at least three times in the POSTHOC app
12 weeks
Usefulness of POSTHOC App
7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful
6 weeks
Usefulness of POSTHOC App
7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful
12 weeks
Likely to Recommend the POSTHOC App
7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely
6 weeks
Cumulative Symptom Burden
6 weeks
Cumulative Symptom Burden
12 weeks
The POSTHOC app is a smartphone application that will deliver the Survivorship Care Plan and promote healthy lifestyle behaviors consistent with the individual's Care Plan
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
James S, Clingan CL, Adesanya IA, Zhu S, Francis ME, Rosenblatt PY, Molitoris JK, Deighton DC, Winder AT, Desrochers PC, McGeorge NM, Kleckner IR, Kleckner AS. Leveraging technology to address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC): A phase I/II randomized controlled trial of a survivorship care plan mobile application. J Cancer Surviv. 2025 Nov 27:10.1007/s11764-025-01946-7. doi: 10.1007/s11764-025-01946-7. Online ahead of print.
Chung KH, Youngblood SM, Clingan CL, Deighton DC, Jump VA, Manuweera T, McGeorge NM, Renn CL, Rosenblatt PY, Winder AT, Zhu S, Kleckner IR, Kleckner AS. Digitizing Survivorship Care Plans Through the POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC) Mobile App: Protocol for a Phase II Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 5;13:e59222. doi: 10.2196/59222.
For 10 consented participants, app download was unsuccessful.
Amber Kleckner, PhD
University of Maryland, Baltimore
51 participants (actual enrollment reported by the registry).
First Submitted
August 10, 2022
First Posted
August 12, 2022
Study Start
March 5, 2024
Actual (reported)Likely to Recommend the POSTHOC App
7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely
12 weeks
Contact the study team to confirm eligibility.
Primary Completion
March 11, 2025
Actual (reported)Study Completion
March 20, 2025
Actual (reported)Last Updated
February 6, 2026
Results First Posted
February 6, 2026
Record last verified: 2025-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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