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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
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.
Enhanced usual care includes a resource list, tablet for study assessments, and reminder calls.
Amanda Khoudary
Hackensack, New Jersey, United States
RECRUITINGFeasibility - Retention (open trial)
Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls.
Time frame: 1-week post-scan
Feasibility - Retention (pilot RCT)
Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls.
Time frame: 3-month post-intervention
Feasibility - Web module engagement (open trial)
Percentage of intervention arm participants who completed at least 70% of the web modules.
Time frame: 1-week pre-scan and 1-week post-scan
Feasibility - Web module engagement (pilot RCT)
Percentage of intervention arm participants who completed at least 70% of the web modules.
Time frame: Post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Acceptability of Intervention - Overall (open trial)
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).
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Acceptability of Intervention - Overall (pilot RCT)
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).
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
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Acceptability - Perceived helpfulness (open trial)
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.
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Acceptability - Perceived helpfulness (Pilot RCT)
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.
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Acceptability - Usability (open trial)
Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Acceptability - Usability (Pilot RCT)
Percentage of participants with ratings ≥4 on a 1-5 Likert item assessing usability of the intervention. Higher scores indicate greater usability.
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Intervention engagement - Daily stress management skill practice (open trial)
Percentage of days in which intervention arm participants self-report practicing stress management skills on a daily log.
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Intervention engagement - Daily stress management skill practice (Pilot RCT)
Percentage of days in which intervention arm participants self-report practicing stress management skills on brief end-of-day surveys.
Time frame: Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization
Anxiety (open trial)
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.
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Anxiety (Pilot RCT)
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.
Time frame: Repeated end-of-day surveys +/- 1 week from cancer scan (anxiety in scan period); up to 16 weeks after randomization
Cancer-related intrusive thoughts (open trial)
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.
Time frame: 1-week Pre-scan, 1-week post-scan, and 1-month follow-up
Cancer-related intrusive thoughts (Pilot RCT)
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.
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)
Stress management skills (open trial)
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.
Time frame: 1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up
Stress management skills (Pilot RCT)
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.
Time frame: post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization)