Clinical trial NCT06199570: Support for Cancer Patients Awaiting News
Official title: Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Stress management
Cancer related anxiety
Scan related anxiety
Advanced lung cancer
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: Advanced cancer patients repeatedly undergo routine scans that inform their disease status and treatment. While awaiting the results, anxiety and uncertainty are elevated, which can negatively impact quality of life. Evidence-based stress management strategies have the potential to be useful during this unique time period, but require tailoring for this population and context.

The goal of this study is to pilot test an adapted stress management program to help patients manage their anxiety while awaiting scan results. The program is a behavioral intervention that includes psychoeducation and stress management activities, delivered via a web platform to promote dissemination. In the Open Trial phase, the program will be field tested in a single-arm trial, using feedback to refine materials and procedures as needed before formal piloting. In the Pilot RCT phase, a small RCT will be conducted to test the intervention's feasibility and acceptability and to examine preliminary effects on anxiety and cancer-related intrusive thoughts.

Eligibility criteria: Inclusion Criteria:

1. Adult (ages 18 and older)
2. Comfortable speaking, reading, and writing English without an interpreter
3. Established diagnosis of 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 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)

Primary outcomes:
measure: Feasibility - Retention
timeFrame: 1-week post-scan
measure: Feasibility - Web module engagement
timeFrame: 1-week pre-scan and 1-week post-scan
measure: Acceptability of Intervention - Overall
timeFrame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
measure: Acceptability - Perceived helpfulness
timeFrame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
measure: Acceptability - Usability
timeFrame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Secondary outcomes:
measure: Intervention engagement - Daily stress management skill practice
timeFrame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
measure: Anxiety
timeFrame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
measure: Cancer-related intrusive thoughts
timeFrame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Amanda Khoudary
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Heather Derry-Vick, PhD
role: PRINCIPAL_INVESTIGATOR
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