Anxiety, Depression in Adults, Lung Cancer (Diagnosis)
Conditions
Keywords
Lung cancer, Anxiety, Depression, Collaborative care
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHigh Touch Outreach
Gain-framed message, informational flyer, and direct request
Sponsors
Abramson Cancer Center at Penn Medicine
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach - Completion of the intake assessment amongst referred patients. | Measured per patient up to 30 days after randomization. | The number of referred patients that complete the intake assessment divided by the total number of referred patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Measured per patient up to 60 days after randomization. | 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. |
| Treatment Retention - Completion of oncology-based collaborative care appointments amongst patients deemed to be appropriate for oncology-based collaborative care at intake. | Measured per patient at end of collaborative care treatment (assessed up to 6 months). | Number of oncology-based collaborative care appointments completed amongst patients deemed to be appropriate for the oncology-based CoCM at intake. |
| Clinical Effectiveness (PHQ-9) - Change in symptom measure using the Patient Health Questionnaire-9 (PHQ-9) validated instrument. | Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months). | 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. |
| Clinical Effectiveness (GAD-7) - Change in symptom measure using the Generalized Anxiety Disorder-7 item (GAD-7) validated instrument. | Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months). | 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. |
| Clinical Effectiveness (PROMIS Fatigue) - Change in symptom measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a validated instrument. | Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months). | 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. |
Countries
United States
Contacts
CONTACTJennifer Steltz, MRA
CONTACTJocelyn Wainwright, MS
PRINCIPAL_INVESTIGATORAlexandria Muench, PsyD
University of Pennsylvania
Outcome results
None listed