Support for Cancer Patients Awaiting News
- Conditions
- Lung Cancer
- Interventions
- Behavioral: Adapted Stress Management ProgramBehavioral: Enhanced Usual Care
- Registration Number
- NCT06199570
- Lead Sponsor
- Hackensack Meridian Health
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Adult (ages 18 and older)
- Comfortable speaking, reading, and writing English without an interpreter
- Established diagnosis of 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adapted Stress Management Program Adapted Stress Management Program The behavioral intervention consists of 3 brief coaching sessions delivered by a trained research interventionist (at baseline/orientation, pre-scan, and post-scan time points) 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. Enhanced Usual Care 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.
- Primary Outcome Measures
Name Time Method Acceptability - Usability 1-week Pre-scan, 1-week post-scan, and 1-month follow-up Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.
Acceptability - Perceived helpfulness 1-week Pre-scan, 1-week post-scan, and 1-month follow-up 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.
Feasibility - Retention 1-week post-scan Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls. The program includes 3 sessions, including those at baseline/orientation, 1-week pre-scan, and 1-week post-scan.
Feasibility - Web module engagement 1-week pre-scan and 1-week post-scan Percentage of intervention arm participants who completed at least 70% of the web modules.
Acceptability of Intervention - Overall 1-week Pre-scan, 1-week post-scan, and 1-month follow-up 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 (Likert scales ranging 1 to 5).
- Secondary Outcome Measures
Name Time Method Intervention engagement - Daily stress management skill practice 1-week Pre-scan, 1-week post-scan, and 1-month follow-up Percentage of days in which intervention arm participants self-report practicing stress management skills on a daily log.
Cancer-related intrusive thoughts 1-week Pre-scan, 1-week post-scan, and 1-month follow-up Cancer-related intrusive thoughts will be measured via validated the Impact of Events 6 item short form survey. Scores range from 0 to 24, with higher scores indicating higher levels of cancer-related intrusive thoughts.
Anxiety 1-week Pre-scan, 1-week post-scan, and 1-month follow-up 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.
Trial Locations
- Locations (1)
Amanda Khoudary
🇺🇸Hackensack, New Jersey, United States