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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA271338 | U.S. NIH Grant/Contract | View source | |
| 857520 | Other Identifier | University of Pennsylvania Institutional Review Board |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The goal of this trial is to compare the impact of two outreach strategies (high touch vs. standard outreach) on a collaborative care program delivered via telehealth to patients with lung cancer.
The goal of this project is to pilot test the effectiveness of using a more-intensive (high touch) outreach strategy to increase the reach of an adapted, standard of care CoCM for patients with lung cancer who are experiencing depression and/or anxiety. The investigators will specifically test the effect of two outreach strategies (high touch vs. standard outreach) on reach of the CoCM program (primary outcome) and on several secondary implementation and effectiveness outcomes. Given the demonstrated efficacy of the CoCM in patients with cancer, the main target of this research study is the impact of the outreach strategies and delivery of the CoCM via telehealth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Touch Outreach | Experimental | Patients in the high touch outreach arm will receive a gain-framed message via text (preferred modality), MyPennMedicine message, email, and/or postal mail that links to the digital screener; an informational flyer about collaborative care sent via postal mail, the MyPennMedicine portal, email, and/or text; and a direct request from their oncology provider to collaborative care for those patients who have not responded to outreach efforts by their next oncology visit post-referral. |
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| Standard Outreach | No Intervention | Patients in the standard outreach arm will receive a standard message sent via text (preferred modality), MyPennMedicine message, email, and/or postal mail that links to the digital screener; this message is one that is similar to that already used in Penn Integrated Care's practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Touch Outreach | Behavioral | Gain-framed message, informational flyer, and direct request |
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| Measure | Description | Time Frame |
|---|---|---|
| Reach - Completion of the intake assessment amongst referred patients. | The number of referred patients that complete the intake assessment divided by the total number of referred patients. | Measured per patient up to 30 days after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Initiation - Completion of one or more oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake. | The number of patients deemed to be appropriate for the oncology-based CoCM at intake who go on to complete one or more oncology-based CoCM appointments divided by the total number of patients deemed to be appropriate for the oncology-based CoCM at intake. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Steltz, MRA | Contact | 215-573-2593 | jennifer.steltz@pennmedicine.upenn.edu | |
| Jocelyn Wainwright, MS | Contact | 215-615-4226 | jocelyn.wainwright@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexandria Muench, PsyD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004194 | Disease |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Measured per patient up to 60 days after randomization. |
| Treatment Retention - Completion of oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake. | Number of oncology-based collaborative care appointments completed amongst patients deemed to be appropriate for the oncology-based CoCM at intake. | Measured per patient at end of collaborative care treatment (assessed up to 6 months). |
| Clinical Effectiveness (PHQ-9) - Change in symptom measure using the Patient Health Questionnaire-9 (PHQ-9) validated instrument. | The change in PHQ-9 score from the patient's collaborative care intake appointment to the appointment most proximal to the patient's discharge. The instrument's minimum value is 0 and maximum value is 27, with a higher score indicating a worse outcome. | Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months). |
| Clinical Effectiveness (GAD-7) - Change in symptom measure using the Generalized Anxiety Disorder-7 item (GAD-7) validated instrument. | The change in GAD-7 score from the patient's collaborative care intake appointment to the appointment most proximal to the patient's discharge. The instrument's minimum value is 0 and maximum value is 21, with a higher score indicating a worse outcome. | Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months). |
| Clinical Effectiveness (PROMIS Fatigue) - Change in symptom measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a validated instrument. | The change in PROMIS Fatigue - Short Form 7a score from the patient's collaborative care intake appointment to the appointment most proximal to the patient's discharge. The instrument's minimum value is 7 and maximum value is 35, with a higher score indicating a worse outcome. | Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months). |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |