希望项目:缓解疼痛和戒烟的健康选择。癌症幸存者计划。
研究概览
详细说明
拟议的试点研究将开发和测试 20 名癌症幸存者戒烟和疼痛管理干预措施的可行性、可接受性和有效性信号。 具体目标有两个:
目标 1:测试行为戒烟和疼痛管理干预联合伐尼克兰的可行性和可接受性。
目标 2:检查戒烟率以及从基线到干预后以及干预后 3 个月的疼痛变化(即严重程度、干扰)、自我效能(即戒烟、疼痛管理)和生活质量基线。
拟议的干预措施可能会对癌症幸存者的健康和生活质量产生重大影响。 教授疼痛管理技术和戒烟技术可以解决幸存者的两个关键问题。
研究团队根据之前的试点研究提交了 R01。 评论家们对同时解决吸烟和疼痛问题的重要性和创新充满热情。 然而,他们并不相信我们试点数据的潜在功效。 他们建议研究小组用伐尼克兰测试相同的干预措施,因为它既可以帮助促进戒烟,又可以提供一定的镇痛作用。 为了解决审稿人的担忧并获得 R01 资助,研究小组建议在我们的行为戒烟和行为疼痛干预相结合的基础上添加伐尼克兰。
背景及意义:
美国目前估计有 1550 万癌症幸存者。 大约 10-30% 的癌症幸存者在诊断时目前是吸烟者。 超过一半 (70%) 诊断时目前吸烟的幸存者会在初次戒烟尝试后恢复吸烟,或在诊断后继续吸烟。 居住在农村地区的人吸烟率更高。 多达 70% 的人还患有疼痛以及其他身体和/或心理社会问题。 尽管一些幸存者相信吸烟可以减轻疼痛和减轻痛苦,但事实上,癌症诊断后持续吸烟与疼痛加剧、生活质量差、疾病复发风险增加以及许多合并症恶化有关。 重要的是,戒烟可以显着改善幸存者对癌症治疗的反应,减少癌症复发,降低新癌症和心血管疾病的风险,并提高生活质量。 因此,帮助幸存者戒烟并学习如何控制疼痛是肿瘤学提供者的首要任务。
迄今为止,尽管经历疼痛的吸烟者报告戒烟自我效能较低,并且对严重戒断和不良戒烟结果的预期较高,但在癌症幸存者中促进戒烟和疼痛管理的最佳实践的整合很少受到关注。 基于我们在戒烟和疼痛管理干预方面的长期专业知识,研究小组建议在我们的试点工作的基础上加入一种可以增强戒烟和疼痛管理的药物。 在药物治疗中,伐尼克兰(即 Chantix)在帮助人们戒烟方面拥有最有力的证据。 伐尼克兰还作用于受体,可能会阻止疼痛。 研究小组提交了 R01,审稿人希望获得更强有力的试点数据,让他们更加相信将戒烟和疼痛管理干预相结合将有助于幸存者戒烟。 因此,除了研究小组从杜克癌症网络(DCN)招募的癌症幸存者中公布的试点数据外,研究小组还建议招募吸烟的幸存者来测试研究小组是否可以通过在我们的研究中添加伐尼克兰来提高我们的戒烟率。行为戒烟疼痛管理计划。 在我们之前的试点中,研究小组发现了有希望的证据,证明行为戒烟与尼古丁替代贴片和行为疼痛管理干预相结合的可行性、可接受性和有效性信号。 接受干预的幸存者认为它对戒烟和疼痛管理有用。 接受干预的幸存者比对照组的幸存者更有可能戒烟,但只有少数幸存者戒烟。 与对照组相比,干预组的幸存者报告称,他们的疼痛、抑郁和身体健康有所改善,但这些变化仍然很小。 因此,在这个拟议的试点中,研究小组将研究在我们的行为计划中添加伐尼克兰是否有助于更多幸存者戒烟并报告更好的疼痛管理。 我们的主要结果将是可行性、可接受性以及未来功效测试行为戒烟和行为疼痛管理+伐尼克兰新组合的潜力的证据。 我们的次要结果将是经过生化验证的 3 个月时戒烟 7 天点患病率。 研究小组还将检查疼痛、自我效能(吸烟、疼痛管理)和生活质量。
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
North Carolina
-
Durham、North Carolina、美国、27710
- Duke University Health System
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 我们的目标招募地点的癌症患者
- 过去 5 年内诊断出患有癌症(目前可能正在接受治疗)
- 预期寿命至少 1 年
- 过去 3 周内报告疼痛程度为 3 分或更高(满分 10 分)
- 一生中至少吸过 100 支烟
- 过去 7 天内每天吸 5 支或更多香烟
- 愿意尝试戒烟
- 不参加另一项戒烟试验
- 18 岁或以上
- 说英语
排除标准:
- 听力障碍
- 被认为病得太重而无法参加
- 无法正确提供同意的不稳定认知或心理健康问题的证据
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:研究人群
所有患者都将接受戒烟和疼痛管理干预以及临床医生处方的伐尼克兰治疗。
|
患者将接受行为戒烟和疼痛管理干预
患者将接受肿瘤科医生开出的伐尼克兰处方
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Complete the Study
大体时间:6 months post-intervention, specifically at 9 months
|
Completing study participation is the number of those who attend all sessions and complete follow-up surveys.
This will serve as the feasibility benchmark.
|
6 months post-intervention, specifically at 9 months
|
|
Number of Participants Who Report That the Intervention Was Helpful
大体时间:6 months post-intervention, specifically at 9 months
|
Participants will be asked if they found the intervention helpful on follow-up surveys.
This will serve as the acceptability benchmark.
|
6 months post-intervention, specifically at 9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Validated Cessation
大体时间:6 months post-intervention, specifically at 9 months
|
Biochemically verified 7-day point prevalence smoking abstinence with use of CO (carbon monoxide) monitors.
|
6 months post-intervention, specifically at 9 months
|
|
Patient-reported Pain Severity
大体时间:Baseline, post-treatment (3 months), 6-month follow-up
|
Patients will report their pain on a scale from 0-10 [0 being "no pain" and 10 being "pain as bad as you can imagine"] on administered surveys at baseline, post-intervention, and 3-month post-intervention.
Study team will look to see if there is a change in patient-reported pain.
|
Baseline, post-treatment (3 months), 6-month follow-up
|
|
Patient-reported Pain Interference
大体时间:Baseline, post-treatment (3 months), 6-month follow-up
|
Patients will report how pain is affecting their lives 0-10 [0 being "does not interfere" and 10 being "completely interferes"] on administered surveys.
|
Baseline, post-treatment (3 months), 6-month follow-up
|
|
Change in Patient-reported Smoking Cessation Self-efficacy
大体时间:Baseline, post-treatment (3 months), 6-month follow-up
|
Patients will report their ability to stop smoking on administered surveys at baseline, post-intervention, and 6 months post-intervention.
Smoking self-efficacy is measured on a scale from 1 to 7 where 1 is "not confident at all" and 7 is "extremely confident".
Study team will look to see if there is a change in patient-reported self-efficacy.
|
Baseline, post-treatment (3 months), 6-month follow-up
|
|
Change in Patient-reported Pain Management Self-efficacy
大体时间:Baseline, post-treatment (3 months), 6-month follow-up
|
Patients will report their ability to manage their pain on administered surveys at baseline, post-intervention, and 6 months post-intervention.
Pain management self-efficacy is measured on a scale of 1-10 where 1 is "very uncertain, 5 is "moderately uncertain", and 10 is "very uncertain".
The total score ranges from 7 to 70, where higher scores indicate greater self-efficacy and confidence in managing daily life with pain.
|
Baseline, post-treatment (3 months), 6-month follow-up
|
|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Anxiety
大体时间:Baseline, post-intervention (3 months), 6-month follow-up
|
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, 3 months post-intervention, and 6 months post-intervention.
Quality of life will be measured based on questions related to Depression/Mood/Negative Affect (Hospital Anxiety Depression Scale - HADS).
The Anxiety subscale has a score ranging from 0-21, where higher scores indicate greater symptom severity.
|
Baseline, post-intervention (3 months), 6-month follow-up
|
|
Change in Patient-reported Quality of Life as Measured by the Hospital Anxiety Depression Scale (HADS) - Depression
大体时间:Baseline, post-intervention (3 months), 6-month follow-up
|
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, 3 months post-intervention, and 6 months post-intervention.
Quality of life will be measured based on questions related to Depression/Mood/Negative Affect (Hospital Anxiety Depression Scale - HADS).
The Depression subscale has a score ranging from 0-21, where higher scores indicate greater symptom severity.
|
Baseline, post-intervention (3 months), 6-month follow-up
|
|
Change in Patient-reported Quality of Life as Measured by the Rhode Island Stress and Coping Inventory - Coping
大体时间:Baseline, post-intervention (3 months), 6-month follow-up
|
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, post-intervention, and 6 months post-intervention.
Quality of life will be measured based on questions from the Coping subscale of the Rhode Island Stress and Coping Inventory.
Patients will answer five questions on scale from 1 = "never" to 5 = "most of the time" and is reported as an average score.
Higher scores indicate stronger coping capabilities.
|
Baseline, post-intervention (3 months), 6-month follow-up
|
|
Change in Patient-reported Quality of Life - Physical Well Being
大体时间:Baseline, post-intervention (3 months), 6-month follow-up
|
Patients will respond to questions about their perceived quality of life on administered surveys at baseline, post-intervention, and 6 months post-intervention.
Quality of life will be measured based on questions related to Physical Well Being.
Patients will answer questions on a 5-point scale from 0 = "not at all" to 4 = "very much".
A higher score indicates worse well being.
|
Baseline, post-intervention (3 months), 6-month follow-up
|
合作者和调查者
调查人员
- 首席研究员:Kathryn I Pollak, PhD、Duke University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.