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ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Enhanced Usual Care

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Adapted Stress Management ProgramExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility - Retention (open trial)

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

Time frame
1-week post-scan
2

Feasibility - Retention (pilot RCT)

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

Time frame
3-month post-intervention
3

Feasibility - Web module engagement (open trial)

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

Time frame
1-week pre-scan and 1-week post-scan
4

Feasibility - Web module engagement (pilot RCT)

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

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

Secondary outcomes

1

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

Percentage of days in which intervention arm participants self-report practicing stress management skills on a daily log.

Time frame
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
2

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

Percentage of days in which intervention arm participants self-report practicing stress management skills on brief end-of-day surveys.

Time frame
Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization
3

Anxiety (open trial)

Anxiety will be measured via the validated PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anxiety Short Form 8a survey. T-scores range from 31.7 to 83.1, with higher scores indicating greater anxiety.

Time frame
1-week Pre-scan, 1-week post-scan, and 1-month follow-up
4

Anxiety (Pilot RCT)

Scores on the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anxiety Short Form 4a survey using brief end-of-day surveys. T-scores range from 40.3 to 81.6 with higher scores indicating higher anxiety.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hackensack Meridian Health

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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