Telehealth Collaborative Care Model (CoCM) in Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are aged 18 years or older.
Are currently being seen by Penn Medicine Thoracic Oncology for lung cancer treatment or survivorship care.
Are referred to collaborative care by a Penn Medicine Thoracic Oncology clinician for treatment of depression, anxiety, or other psycho-therapy services.
Disqualifiers
Are already receiving psycho-therapy treatment services outside of Penn Medicine's collaborative care program, Penn Integrated Care (PIC).
Have a significant and/or untreated medical and/or psychiatric co-morbidity (e.g., other cancers, schizophrenia, acute suicidal and/or homicidal ideation) that make them ineligible for the Penn CoCM program.
Trial design
Design model
Parallel
Treatments tested in this trial
High Touch Outreach
BehavioralGain-framed message, informational flyer, and direct request
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: High Touch OutreachExperimental treatment 1 intervention
Group B: Standard OutreachNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Measured per patient up to 30 days after randomization.Secondary outcomes
1
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.2
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).3
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).4
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.
Time frame
Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov