Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program
概览
- 阶段
- 不适用
- 干预措施
- Adapted Stress Management Program
- 疾病 / 适应症
- Lung Cancer
- 发起方
- Hackensack Meridian Health
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility - Retention (open trial)
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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).
详细描述
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.
研究者
入排标准
入选标准
- •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 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)
- •Willingness to use the study website
排除标准
- •Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen)
- •Requires an interpreter for medical visits
- •Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)
- •Currently enrolled in hospice
- •Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)
研究组 & 干预措施
Adapted Stress Management Program
The behavioral intervention consists of 3 brief coaching sessions delivered by a trained research interventionist and program modules consisting of psychoeducation and stress management skill activities/practice. They will also be provided with a list of mental health resources and crisis line information for use if needed.
干预措施: Adapted Stress Management Program
Enhanced Usual Care
Those randomized to enhanced usual care in the pilot RCT (n=25) will receive a resource list, tablet for study assessments, and reminder calls, but will not receive the program modules. They will also be provided with a list of mental health resources and crisis line information for use if needed.
干预措施: Enhanced Usual Care
结局指标
主要结局
Feasibility - Retention (open trial)
时间窗: 1-week post-scan
Percentage of intervention arm participants who completed 2 out of 3 intervention sessions/calls.
Feasibility - Retention (pilot RCT)
时间窗: 3-month post-intervention
Percentage of intervention arm participants who completed 2 out of 3 coaching sessions/calls.
Feasibility - Web module engagement (open trial)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Intervention engagement - Daily stress management skill practice (open trial)(1-week Pre-scan, 1-week post-scan, and 1-month follow-up)
- 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)
- Anxiety (open trial)(1-week Pre-scan, 1-week post-scan, and 1-month follow-up)
- Anxiety (Pilot RCT)(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)(1-week Pre-scan, 1-week post-scan, and 1-month follow-up)
- Cancer-related intrusive thoughts (Pilot RCT)(post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization))
- Stress management skills (open trial)(1-week pre-scan, 1-week post-scan, and 1-month post-scan follow-up)
- Stress management skills (Pilot RCT)(post-intervention (approx 3 weeks after randomization) and 3-months post-intervention (approx 16 weeks after randomization))