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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
30
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Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGReach - 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.
Time frame: Measured per patient up to 30 days after randomization.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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.
Time frame: 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.
Time frame: Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).