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| ID | Type | Description | Link |
|---|---|---|---|
| 75N91021C00019-0-9999-1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Charles River Analytics | INDUSTRY |
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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 Survivorship Care Plans are currently static documents that are provided via paper and become outdated as soon as the person's health status changes.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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POSTHOC app | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amber Kleckner, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41307872 | Derived | 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. | |
| 39235855 |
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Completion of baseline assessments was necessary before randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | POSTHOC App | 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 |
| FG001 | Control | Usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | POSTHOC App | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 12 weeks |
|
From enrollment to the end of 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POSTHOC App | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer metastasis | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
For 10 consented participants, app download was unsuccessful.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amber Kleckner | University of Maryland School of Nursing | 4107065961 | amber.kleckner@umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 17, 2024 | Dec 16, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012816 | Signs and Symptoms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| 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. | 12 weeks |
| 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. |
Usual care
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Control |
Usual care. These participants downloaded the POSTHOC app, but only had access to the Ecological Momentary Assessment feature of the app. |
|
|
| Primary | Usefulness of POSTHOC App | 7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful | Posted | Mean | Standard Deviation | points | 6 weeks |
|
|
|
| Primary | Usefulness of POSTHOC App | 7-point Likert scale for usefulness flanked by 1=not at all useful and 7=extremely useful | Posted | Mean | Standard Deviation | points | 12 weeks |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | points | 6 weeks |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | points | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | points | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | points | 12 weeks |
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|
| 0 |
| 23 |
| 1 |
| 23 |
| 0 |
| 23 |
| EG001 | Control | Usual care | 0 | 11 | 0 | 11 | 1 | 11 |
| EG002 | Before Randomization | Participants who consented to the study but then withdrew before randomization | 0 | 17 | 1 | 17 | 0 | 17 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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