Recruiting

Stress Management

Sponsor:

Hackensack Meridian Health

Code:

NCT06199570

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adapted Stress Management Program

Enhanced Usual Care

Study Details

Brief summary:

This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and/or protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).

Conditions

Lung Cancer

Study ID

NCT06199570

Start date

May 1, 2024

Status verified date

Aug, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult (ages 18 and older)
2. Comfortable speaking, reading, and writing English without an interpreter
3. Established diagnosis of lung cancer (3a. Open Trial phase only: Stage III-IV lung cancer or extensive stage small cell lung cancer)
4. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
5. Receiving ongoing care from collaborating clinics with regular scans
6. Receiving systemic treatment for lung cancer
7. Endorse at least mild anxiety (using the PROMIS Anxiety 4a) or appointment- or scan-related stress on 4-item screen (using a modified Distress Thermometer item, a Fear of Progression scale item, an Impact of Events scale item, and an item from our prior study)
8. Willingness to use the study website

Exclusion Criteria:

1. Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen)
2. Requires an interpreter for medical visits
3. Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)
4. Currently enrolled in hospice
5. Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Adapted Stress Management Program

The behavioral intervention consists of 3 brief coaching sessions delivered by a trained research interventionist and program modules consisting of psychoeducation and stress management skill activities/practice. They will also be provided with a list of mental health resources and crisis line information for use if needed.

active comparator: Enhanced Usual Care

Those randomized to enhanced usual care in the pilot RCT (n=25) will receive a resource list, tablet for study assessments, and reminder calls, but will not receive the program modules. They will also be provided with a list of mental health resources and crisis line information for use if needed.

Interventions

Adapted Stress Management Program

Participants will receive a 15-minute orientation session in-person or remotely to introduce the program and to receive the study materials, including the instructional sheet, small booklet, and study tablet that will be used to promote practice of stress management exercises and for completing study assessments. They will complete self-guided web modules with stress management activities/skills on tablet devices, and will rate the modules' acceptability and perceived helpfulness. After visiting each module, they will be asked to practice at least one skill daily. In a second coaching session, they will be reminded about the skills, make a plan for using them, and troubleshoot questions about using the materials. Participants will attend scans and scan result appointments with their oncologist as usual. In a third coaching session, the stress management plan will be revisited for new concerns.

Enhanced Usual Care

Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.

Primary outcome measure

  • Feasibility - Retention (open trial) [ Time Frame: 1-week post-scan ]
  • Feasibility - Retention (pilot RCT) [ Time Frame: 3-month post-intervention ]
  • Feasibility - Web module engagement (open trial) [ Time Frame: 1-week pre-scan and 1-week post-scan ]
  • Feasibility - Web module engagement (pilot RCT) [ Time Frame: Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) ]
  • Acceptability of Intervention - Overall (open trial) [ Time Frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up ]
  • Acceptability of Intervention - Overall (pilot RCT) [ Time Frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) ]
  • Acceptability - Perceived helpfulness (open trial) [ Time Frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up ]
  • Acceptability - Perceived helpfulness (Pilot RCT) [ Time Frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) ]
  • Acceptability - Usability (open trial) [ Time Frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up ]
  • Acceptability - Usability (Pilot RCT) [ Time Frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) ]

Central Contacts and Locations

Central contacts

Amanda Khoudary, BA

2018803445Amanda.Khoudary@hmh-cdi.org

Locations

Amanda Khoudary

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Amanda Khoudary

201-880-3445Amanda.Khoudary@hmh-cdi.org

Principal Investigator:

Heather Derry-Vick, PhD

More Information

Sponsor

Hackensack Meridian Health

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • Stress management
  • Cancer related anxiety
  • Scan related anxiety
  • Advanced lung cancer
  • lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-08-04.