Telehealth Collaborative Care Model (CoCM) in Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Touch Outreach.
- Who it may be relevant to
- Registry conditions: Lung Cancer (Diagnosis), Anxiety, Depression in Adults. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Increasing Adoption of a Telehealth-Delivered Collaborative Care Program for Patients With Lung Cancer: A Pilot Study
Overview
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
- Behavioral High Touch Outreach
Gain-framed message, informational flyer, and direct request
Primary outcome measures
- Reach - Completion of the intake assessment amongst referred patients. [Time frame: Measured per patient up to 30 days after randomization.]
Secondary outcome measures (5)
- 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. [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. [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. [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. [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. [Time frame: Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Abramson Cancer Center at the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07102147 · UPCC 31524 · P50CA271338 · 857520