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Title: Leveraging Technology to Address Health Outcomes of Cancer Survivors
Phase 1, PHASE2 trial testing POSTHOC app in Survivorship in 51 participants. Completed in 20 March 2025.
| Lead sponsor | University of Maryland, Baltimore |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 51 |
| Start date | 5 March 2024 |
| Primary completion | 11 March 2025 |
| Estimated completion | 20 March 2025 |
| Sites | 1 location across United States |
University of Maryland, Baltimore
18 and older, any sex, with Survivorship or Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants who logged data at least three times in the POSTHOC app
| Group | Value | 95% CI |
|---|---|---|
| POSTHOC App | 12 | |
| Control | 1 |
7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful
| Group | Value | 95% CI |
|---|---|---|
| POSTHOC App | 3.4 | ± 2.0 |
7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful
| Group | Value | 95% CI |
|---|---|---|
| POSTHOC App | 4.3 | ± 2.3 |
7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely
| Group | Value | 95% CI |
|---|---|---|
| POSTHOC App | 4.2 | ± 2.2 |
7-point Likert scale flanked by 1=not at all likely to recommend to others and 7=extremely likely
| Group | Value | 95% CI |
|---|---|---|
| POSTHOC App | 4.4 | ± 2.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| POSTHOC App | 20.0 | ± 20.8 |
| Control | 18.6 | ± 18.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| POSTHOC App | 19.8 | ± 21.4 |
| Control | 26.7 | ± 21.7 |
Time frame: From enrollment to the end of 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | POSTHOC App | Control | Before Randomization |
|---|---|---|---|---|
| Cancer metastasis | Nervous system disorders | — | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Reaction | System | POSTHOC App | Control | Before Randomization |
|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
Most-reported serious reactions: Cancer metastasis, Pneumonia.
Data from ClinicalTrials.gov NCT05499663 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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