Lung Cancer (Diagnosis)NCT07102147
Telehealth Collaborative Care Model (CoCM) in Lung Cancer
A study testing High Touch Outreach in people with Lung Cancer (Diagnosis) and Anxiety, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis), Anxiety, Depression in Adults
- What is being tested?
- High Touch Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Alexandria Muench, PsyD, 215-421-4491, amuench@pennmedicine.upenn.edu
Courtney Wolk, PhD
About this study
Official title: Increasing Adoption of a Telehealth-Delivered Collaborative Care Program for Patients With Lung Cancer: A Pilot Study
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.
Read the 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.
- Conditions
- Lung Cancer (Diagnosis), Anxiety, Depression in Adults
- Being tested
- High Touch Outreach
- Keywords
- Lung cancer, Anxiety, Depression, Collaborative care
- Medical subject headings
- Lung Neoplasms, Disease, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Touch OutreachBehavioural
Gain-framed message, informational flyer, and direct request
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
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.
Measured: 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.
Number of oncology-based collaborative care appointments completed amongst patients deemed to be appropriate for the oncology-based CoCM at intake.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Measured per patient at first collaborative care appointment (baseline) and at end of collaborative care treatment (up to 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start18 Aug 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alexandria Muench, Abramson Cancer Center at Penn Medicine
- Investigators
- Alexandria Muench, PsyD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102147
- Sponsor's protocol ID
- UPCC 31524
- Other IDs
- P50CA271338, 857520
- Status last verified
- May 2026
- First submitted
- 18 Jul 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Adoption of a Telehealth-Delivered Collaborative Care Program for Patients With Lung Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT07102147
- Acronym / sponsor ID
- UPCC 31524
- Conditions
- Lung Cancer (Diagnosis), Anxiety, Depression in Adults
- Keywords
- Lung cancer, Anxiety, Depression, Collaborative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Touch Outreach | Experimental | Behavioral: High Touch OutreachPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Touch OutreachGain-framed message, informational flyer, and direct request | Behavioural | High Touch Outreach |
Primary outcome
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.
5 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandria Muench, PsyD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Touch Outreach in people with Lung Cancer (Diagnosis) and Anxiety, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Steltz, MRA (215-573-2593, jennifer.steltz@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach - Completion of the intake assessment amongst referred patients. (time frame: Measured per patient up to 30 days after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.