Support for Cancer Patients Awaiting News

Trial Title: Support for Cancer Patients Awaiting News

NCT ID: NCT06199570

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Stress management
Cancer related anxiety
Scan related anxiety
Advanced lung cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Adapted Stress Management Program
Description: 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 1-week pre-scan call, 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 1-week post-scan phone call, the stress management plan will be revisited for new concerns.
Arm group label: Adapted Stress Management Program

Intervention type: Behavioral
Intervention name: Enhanced Usual Care
Description: Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.
Arm group label: Enhanced Usual Care

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.

Criteria for 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. Initiated systemic cancer treatment for current diagnosis within the past 3 months or less 7. Endorse appointment- or scan-related stress on 3-item screen (using modified items from distress thermometer, Fear of Progression scale, and Impact of Events scales) 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Amanda Khoudary

Address:
City: Hackensack
Zip: 07601
Country: United States

Status: Recruiting

Contact:
Last name: Amanda Khoudary

Phone: 201-880-3445
Email: Amanda.Khoudary@hmh-cdi.org

Investigator:
Last name: Heather Derry-Vick, PhD
Email: Principal Investigator

Start date: May 1, 2024

Completion date: April 30, 2025

Lead sponsor:
Agency: Hackensack Meridian Health
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Hackensack Meridian Health

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06199570