Telehealth Collaborative Care Model (CoCM) in Lung Cancer

NCT07102147 | Recruiting

• 3 other identifiers: UPCC 31524P50CA271338857520
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (Diagnosis); Anxiety; Depression in Adults

Keywords

Lung cancer; Anxiety; Depression; Collaborative care

Outcome Measures

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.

  Measured per patient up to 30 days after randomization.

Secondary Outcomes (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.

  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.

  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.

  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.

  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.

  Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).

Study Arms (2)

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.

Behavioral: High Touch Outreach

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.

Interventions

High Touch Outreach BEHAVIORAL

Gain-framed message, informational flyer, and direct request

High Touch Outreach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alexandria Muench, PsyD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Steltz, MRA

CONTACT

215-573-2593; jennifer.steltz@pennmedicine.upenn.edu

Jocelyn Wainwright, MS

CONTACT

215-615-4226; jocelyn.wainwright@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychologist

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 3, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)