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OpenTrials
Completed

NCT Number: NCT05499663

Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors

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 Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes.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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

POSTHOC app

Behavioral

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

Primary outcomes

  1. Number of Participants Who Logged Data at Least Three Times in the POSTHOC App

    Time frame: 12 weeks

    Number of participants who logged data at least three times in the POSTHOC app

  2. Usefulness of POSTHOC App

    Time frame: 6 weeks

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

  3. Usefulness of POSTHOC App

    Time frame: 12 weeks

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

  4. Likely to Recommend the POSTHOC App

    Time frame: 6 weeks

    7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely

  5. Likely to Recommend the POSTHOC App

    Time frame: 12 weeks

    7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely

Secondary outcomes

  1. Cumulative Symptom Burden

    Time frame: 6 weeks

    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.

  2. Cumulative Symptom Burden

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Charles River Analytics
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: POSTHOC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2022
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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