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NCT Number: NCT07102147

Telehealth Collaborative Care Model (CoCM) in Lung Cancer

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.

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Key information

Conditions

Lung Cancer (Diagnosis) Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depression in Adults Disease Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Aditi Singh, MD

SUB_INVESTIGATOR

Alexandria Muench, PsyD

CONTACT

[email protected]

215-421-4491

Anil Vachani, MD, MS

SUB_INVESTIGATOR

Courtney Wolk, PhD

SUB_INVESTIGATOR

Eleanor Anderson, MD

SUB_INVESTIGATOR

Faith Mutale, CRNP

SUB_INVESTIGATOR

Katharine Rendle, PhD, MSW

SUB_INVESTIGATOR

Kristin Linn, PhD

SUB_INVESTIGATOR

Matthew Press, MD, MSc

SUB_INVESTIGATOR

Tiffany Hogan, MA, CCC-SLP

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Touch Outreach

Behavioral

Gain-framed message, informational flyer, and direct request

Primary outcomes

  1. Reach - Completion of the intake assessment amongst referred patients.

    Time frame: 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 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.

    Time frame: 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.

  2. 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).

    Number of oncology-based collaborative care appointments completed amongst patients deemed to be appropriate for the oncology-based CoCM at intake.

  3. 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).

    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.

  4. 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).

    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.

  5. 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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Steltz, MRA

CONTACT

[email protected]

215-573-2593

Jocelyn Wainwright, MS

CONTACT

[email protected]

215-615-4226

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Increasing Adoption of a Telehealth-Delivered Collaborative Care Program for Patients With Lung Cancer: A Pilot Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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