Support for Cancer Patients Awaiting News (NCT06199570) | Clinical Trial Compass
RecruitingNot Applicable
Support for Cancer Patients Awaiting News
United States60 participantsStarted 2024-05-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult (ages 18 and older)
. Comfortable speaking, reading, and writing English without an interpreter
. Established diagnosis of lung cancer (3a. Open Trial phase only: 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 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be testing whether an online support program is feasible and acceptable for lung cancer patients waiting for news — rather than testing a new drug or treatment — so could you help me understand what kind of 'news' or waiting period this is actually designed for, and whether my current situation fits that?
2Since this study is in a very early stage focused on whether the web-based program works well enough to keep people engaged and whether they find it helpful, rather than proving it improves health outcomes, what does that mean for what I might actually get out of participating compared to other support resources already available to me?
3The trial involves a web module, so how much time and tech comfort would I realistically need, and given everything else I'm managing with my diagnosis, is this something you think would be feasible for me right now?
4Because this is a feasibility and acceptability study and not a phase testing treatment effectiveness, is there any standard psychosocial support or counseling you'd recommend I pursue alongside or instead of this trial?
5I noticed this is structured as an open trial moving toward a pilot randomized controlled trial — could I end up being assigned to a group that doesn't receive the web support program, and if so, what would I receive instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility - Retention (open trial)
Timeframe: 1-week post-scan
2
Feasibility - Retention (pilot RCT)
Timeframe: 3-month post-intervention
3
Feasibility - Web module engagement (open trial)
Timeframe: 1-week pre-scan and 1-week post-scan
4
Feasibility - Web module engagement (pilot RCT)
Timeframe: Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
5
Acceptability of Intervention - Overall (open trial)
Timeframe: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
6
Acceptability of Intervention - Overall (pilot RCT)
Timeframe: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)