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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00190175 | Other Identifier | University of Michigan |
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This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message survey, a pre-programmed, automated response will be sent from the study prompting the patient to take specific actions (or no action if no symptoms). Investigators will assess whether this method improves patients' well-being as compared to the current standard of care for patients. Currently, after surgery, patients are provided counseling and written instructions when they leave the hospital on how to care for themselves at home. If the patient has questions or concerns, they contact their care team. The optimal way to help patients assess their own symptoms at home remains unknown. Investigators are also assessing if using the symptom survey reduces readmissions to the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Post-Operative Counseling + FACT-G (Control Arm) | Active Comparator | Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. Patients will complete the Functional Assessment of Cancer Therapy - General (FACT-G). |
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| Standard Post-Operative Counseling + PROM survey + FACT-G (Intervention Arm) | Experimental | Patients will receive the standard postoperative counseling at discharge, discharge instructions, and the link to website with postoperative instructions. The intervention arm will receive and complete the Patient-Reported Outcome Measure (PROM) survey via the SMS text messaging service on a set schedule. Patients will complete the FACT-G. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Post-Operative Counseling + FACT-G | Behavioral | Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean total score on FACT-G | The mean total score on the FACT-G will be compared between the two arms. The FACT-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. The minimally important difference (MID) is 5 points for the FACT-G questionnaire. In other words, five points is the most minimal difference between the control group and treatment group scores that would indicate a clinically meaningful change. A positive change in points indicates better QOL. | 30-32 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who had non-standard clinic visits | The proportion of patients who are seen in the clinic for visits other than a scheduled post-operative visit. Data collected by chart review. | 30 days post-operative |
| Proportion of patients who called the care team |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shitanshu Uppal, MBBS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| PROM symptom tracker | Behavioral | A 12-item symptom tracker adopted from the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE), delivered via text, on days 4, 6, 8, 12, 18, 24, and 30 post surgery. |
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Data collected by chart review. |
| 30 days post-operative |
| Proportion of patients seen in urgent care clinics | Data collected by chart review. | 30 days post-operative |
| Proportion of patients seen in emergency room | Data collected by chart review. | 30 days post-operative |
| Proportion of patients readmitted to hospital | Data collected by chart review. | 30 days post-operative |