Support for Cancer Patients Awaiting News

Lung Cancer Clinical Trial

— SCAN  

Official title:

Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06199570
• Other study ID #: Pro2022-0930
• Secondary ID: R00CA245488
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Hackensack Meridian Health
• Contact: Amanda Khoudary, BA
• Phone: 2018803445
• Email: Amanda.Khoudary[@]hmh-cdi.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult (ages 18 and older)

2. Comfortable speaking, reading, and writing English without an interpreter

3. Established diagnosis of Stage 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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Adapted 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 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.
• Enhanced Usual Care
Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.

Locations

Country	Name	City	State
United States	Amanda Khoudary	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hackensack Meridian Health	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Retention	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.	1-week post-scan
Primary	Feasibility - Web module engagement	Percentage of intervention arm participants who completed at least 70% of the web modules.	1-week pre-scan and 1-week post-scan
Primary	Acceptability of Intervention - Overall	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).	1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Primary	Acceptability - Perceived helpfulness	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.	1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Primary	Acceptability - Usability	Percentage of participants with ratings =4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.	1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Secondary	Intervention engagement - Daily stress management skill practice	Percentage of days in which intervention arm participants self-report practicing stress management skills on a daily log.	1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Secondary	Anxiety	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.	1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Secondary	Cancer-related intrusive thoughts	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.	1-week Pre-scan, 1-week post-scan, and 1-month follow-up