Lung Cancer
Conditions
Keywords
Stress management, Cancer related anxiety, Scan related anxiety, Advanced lung cancer, lung cancer
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
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 other secondary outcomes.
Interventions
BEHAVIORALAdapted 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.
BEHAVIORALEnhanced Usual Care
Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.
Sponsors
Hackensack Meridian Health
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Retention (open trial) | 1-week post-scan | Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls. |
| Feasibility - Retention (pilot RCT) | 3-month post-intervention | Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls. |
| Feasibility - Web module engagement (open trial) | 1-week pre-scan and 1-week post-scan | Percentage of intervention arm participants who completed at least 70% of the web modules. |
| Feasibility - Web module engagement (pilot RCT) | Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) | Percentage of intervention arm participants who completed at least 70% of the web modules. |
| Acceptability of Intervention - Overall (open trial) | 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 (mean scores ranging from 1 to 5, with higher scores indicating better acceptability). |
| Acceptability of Intervention - Overall (pilot RCT) | post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) | 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). |
| Acceptability - Perceived helpfulness (open trial) | 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. |
| Acceptability - Perceived helpfulness (Pilot RCT) | post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) | 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. |
| Acceptability - Usability (open trial) | 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 - Usability (Pilot RCT) | post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) | Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention engagement - Daily stress management skill practice (open trial) | 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. |
| 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 | Percentage of days in which intervention arm participants self-report practicing stress management skills on brief end-of-day surveys. |
| Anxiety (open trial) | 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. |
| Anxiety (Pilot RCT) | Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization | 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. |
| Cancer-related intrusive thoughts (open trial) | 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. |
| Cancer-related intrusive thoughts (Pilot RCT) | post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) | 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. |
| Stress management skills (open trial) | 1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up | Perceived stress management skill will be measured via the validated Measure of Current Status survey. Total scores range from 0 to 52 with higher scores indicating better stress management skills. |
| Stress management skills (Pilot RCT) | post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization) | Perceived stress management skill will be measured via the validated Measure of Current Status survey. Total scores range from 0 to 52 with higher scores indicating better stress management skills. |
Countries
United States
Contacts
CONTACTAmanda Khoudary, BA
PRINCIPAL_INVESTIGATORHeather Derry-Vick, PhD
Hackensack Meridian Health
Outcome results
None listed