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SurvivorshipPhase 1/2POSTHOCNCT05499663

Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors

A Phase 1/2 study testing POSTHOC app in people with Survivorship and Cancer, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Survivorship, Cancer, Symptoms and Signs
What is being tested?
POSTHOC app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
5 Mar 2024to 20 Mar 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Have had a cancer diagnosis (any type)
  • Will soon or have recently completed treatment (within the past 12 weeks) with chemotherapy, radiotherapy, or surgery with curative intent
  • Must have received, plans to receive, or open to receiving a Survivorship Care Plan (SCP) as per their provider
  • Have access to a device capable of running the POSTHOC app and Fitbit app (e.g., Android or Apple smartphone) and reliable Internet access
  • Be at least 18 years of age
  • Be able to read and understand English, and
  • Be able to provide written informed consent

Who cannot join

  • Have planned surgery, radiotherapy, or surgery during the study period (hormonal and biologic therapy is allowed)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Leveraging Technology to Address POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC-II): A Phase II Survivorship Care Plan Randomized Controlled Trial

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.

Being tested
POSTHOC app
Keywords
mobile health, mhealth, exercise, nutrition, behavior change
Medical subject headings
Neoplasms, Signs and Symptoms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POSTHOC appBehavioural

    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

Study groups in NCT05499663
Study groupRoleWhat they receive
POSTHOC appExperimentalNot described
Receives: Behavioral: POSTHOC app
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. Usefulness of POSTHOC App

    7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful

    Measured: 6 weeks

  3. Usefulness of POSTHOC App

    7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful

    Measured: 12 weeks

  4. 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

    Measured: 6 weeks

  5. 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

    Measured: 12 weeks

Secondary outcomes (2)

  1. Cumulative Symptom Burden

    This is a sum of severities of the core patient-reported symptoms from the MD Anderson Symptom Inventory, including fatigue, insomnia, pain, appetite loss, dyspnea (shortness of breath), cognitive problems, nausea, distress, and sensory neuropathy. The scale ranges from 0-130. A higher score indicates higher symptom burden.

    Measured: 6 weeks

  2. Cumulative Symptom Burden

    This is a sum of severities of the core patient-reported symptoms from the MD Anderson Symptom Inventory, including fatigue, insomnia, pain, appetite loss, dyspnea (shortness of breath), cognitive problems, nausea, distress, and sensory neuropathy. The scale ranges from 0-130. A higher score indicates higher symptom burden.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2022
  2. Study start5 Mar 2024
  3. Primary completion11 Mar 2025
  4. Study completion20 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05499663
Sponsor's protocol ID
HP-00100473
Other IDs
75N91021C00019-0-9999-1
Acronym
POSTHOC
Status last verified
Dec 2025
First submitted
10 Aug 2022
Last updated
6 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41307872

  • 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.

    PubMed 39235855

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing POSTHOC app in people with Survivorship and Cancer, run by University of Maryland, Baltimore 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 7 inclusion and 1 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 6 Feb 2026. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Logged Data at Least Three Times in the POSTHOC App (time frame: 12 weeks). 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?

On the ClinicalTrials.gov record for NCT05499663, which also lists 2 linked publications.

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 6 Feb 2026.

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