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NCT06199570 | Recruiting

• 2 other identifiers: Pro2022-0930R00CA245488
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Feasibility - Retention (open trial)

  Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls.

  1-week post-scan

• Feasibility - Retention (pilot RCT)

  Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls.

  3-month post-intervention

• Feasibility - Web module engagement (open trial)

  Percentage of intervention arm participants who completed at least 70% of the web modules.

  1-week pre-scan and 1-week post-scan

• Feasibility - Web module engagement (pilot RCT)

  Percentage of intervention arm participants who completed at least 70% of the web modules.

  Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

• Acceptability of Intervention - Overall (open trial)

  Percentage of intervention arm participants with mean ratings ≥4 on the validated Acceptability of Intervention Measure (AIM). Higher scores indicate greater acceptability. Acceptability will be assessed via participant ratings (mean scores ranging from 1 to 5, with higher scores indicating better acceptability).

  1-week Pre-scan, 1-week post-scan, and 1-month follow-up

• Acceptability of Intervention - Overall (pilot RCT)

  Percentage of intervention arm participants with mean ratings ≥4 on the validated Acceptability of Intervention Measure (AIM). Higher scores indicate greater acceptability. Acceptability will be assessed via participant ratings (mean scores ranging from 1 to 5, with higher scores indicating better acceptability).

  post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

• Acceptability - Perceived helpfulness (open trial)

  Percentage of intervention arm participants with ratings ≥4 on a 1-5 Likert item assessing perceived helpfulness of the intervention. Higher scores indicate greater perceived helpfulness.

  1-week Pre-scan, 1-week post-scan, and 1-month follow-up

• Acceptability - Perceived helpfulness (Pilot RCT)

  Percentage of intervention arm participants with ratings ≥4 on a 1-5 Likert item assessing perceived helpfulness of the intervention. Higher scores indicate greater perceived helpfulness.

  post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

• Acceptability - Usability (open trial)

  Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.

  1-week Pre-scan, 1-week post-scan, and 1-month follow-up

• Acceptability - Usability (Pilot RCT)

  Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.

  post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)

Secondary Outcomes (8)

• Intervention engagement - Daily stress management skill practice (open trial)

  1-week Pre-scan, 1-week post-scan, and 1-month follow-up

• Intervention engagement - Daily stress management skill practice (Pilot RCT)

  Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization

• Anxiety (open trial)

  1-week Pre-scan, 1-week post-scan, and 1-month follow-up

• Anxiety (Pilot RCT)

  Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization

• Cancer-related intrusive thoughts (open trial)

  1-week Pre-scan, 1-week post-scan, and 1-month follow-up

Study Arms (2)

Adapted Stress Management Program

EXPERIMENTAL

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.

Behavioral: Adapted Stress Management Program

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

Enhanced Usual Care BEHAVIORAL

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

Enhanced Usual Care

Adapted Stress Management Program BEHAVIORAL

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.

Adapted Stress Management Program

Eligibility Criteria

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

You may qualify if:

• Adult (ages 18 and older)
• Comfortable speaking, reading, and writing English without an interpreter
• Established diagnosis of lung cancer (3a. Open Trial phase only: Stage III-IV lung cancer or extensive stage small cell lung cancer)
• ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
• Receiving ongoing care from collaborating clinics with regular scans
• Receiving systemic treatment for lung cancer
• Endorse 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)
• Willingness to use the study website

You may not qualify if:

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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Amanda Khoudary

Hackensack, New Jersey, 07601, United States

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Heather Derry-Vick, PhD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Khoudary, BA

CONTACT

2018803445; Amanda.Khoudary@hmh-cdi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Trial phase: Unblinded, single-site, single-arm open trial (n=10). Pilot RCT phase: Unblinded, single-site, feasibility pilot randomized controlled trial (n=50; adapted stress management program vs. enhanced usual care).

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 10, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)