Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) with Mediational Analysis
乳房切除术后持续疼痛:针对性疼痛应对技能训练(Targeted-PCST)与中介分析的随机临床试验
基本信息
- 批准号:10608174
- 负责人:
- 金额:$ 61.95万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-04-01 至 2025-03-31
- 项目状态:未结题
- 来源:
- 关键词:AcuteAddressAdoptionAffectAnxietyAutomobile DrivingAwardBreastBreast Cancer PatientBreast Cancer survivorCancer CenterClinicClinicalClinical Trials DesignCoping SkillsDistressEducational InterventionEtiologyExcisionFinancial costHealth educationInstitutionInterventionMalignant NeoplasmsManualsMastectomyMediatingMediatorMental DepressionNewly DiagnosedOncologyOperative Surgical ProceduresPainPain interferenceParticipantPatientsPersistent painPharmacological TreatmentPhysical FunctionPostoperative PainPrevalenceProcessPsychosocial FactorPublic HealthQuality of lifeRandomizedResearchRoleSelf EfficacySensorySeveritiesSiteSurvivorsTestingTraumaUniversitiesWomanbreast lumpectomycancer surgerycentral sensitizationclinically significantcurative treatmentsdesigneffective interventionefficacy evaluationemotional distressemotional functioningexperiencefollow-upimprovedintervention costmalignant breast neoplasmnovelpain catastrophizingpain reductionpain sensitivitypilot testpost interventionprimary outcomepsychobiologicpsychologicrandomized, clinical trialsresponsesecondary outcomeskills trainingtreatment as usual
项目摘要
Abstract
Persistent pain following breast cancer surgery is increasingly recognized as an important clinical and public
health issue due to the large number of women affected, the powerful negative impact that persistent pain has
on emotional and physical functioning and its financial costs. Most of the more than a quarter of a million
women newly diagnosed with breast cancer in the U.S. this year will undergo surgery as a part of curative
treatment. The prevalence of persistent pain following surgical removal of the affected breast (mastectomy) or
more limited surgeries (lumpectomy) is high, ranging from 25-60% across studies. Unlike acute post-operative
pain, which is a normal response to surgical trauma, persistent pain at or near the surgical site has an
uncertain multifaceted etiology, and no satisfactory pharmacological treatment. A critical question is whether
key pain-related psychosocial factors are drivers of the continuing burden of persistent pain, and whether they
could be ameliorated by non-pharmacological intervention. The research planned under this award will provide
a first critical test of the hypothesized driving role of pain catastrophizing in persistent pain after breast cancer
surgery. It also will explore the role of two other key psychosocial variables that may contribute to the burden
associated with persistent pain after breast cancer surgery: self-efficacy for engaging in valued activities and
psychological inflexibility. We have developed, manualized, and pilot tested a pain coping skills training
intervention that specifically targets the needs of women with persistent pain following breast cancer surgery
(Targeted PCST) and aims to reduce pain catastrophizing, increase self-efficacy for engaging in valued
activities, and decrease psychological inflexibility. We propose a multiple-site, randomized clinical trial to
evaluate the efficacy of the Targeted-PCST intervention. The study will be conducted in 9 diverse oncology
clinics: 5 affiliated with Duke University/Duke Cancer Network and 4 affiliated with the University of
Pittsburgh/UPMC Hillman Cancer Center. Participants (N=564) will be randomized to either receive: 1)
Targeted-PCST, 2) a general health education intervention (control), or 3) usual care (control). Participants will
complete assessments pre-intervention and at 3 months (post-intervention), 6 months follow-up, and 12
months follow-up. Study aims are: Aim1: Examine the impact of Targeted-PCST on persistent post-surgical
pain severity and interference (i.e., PEG score), emotional distress (anxiety and depression), and cancer-
specific distress. Aim 2: Investigate the impact of Targeted-PCST on pain catastrophizing, pain self-efficacy,
and psychological inflexibility, and evaluate these variables as possible mediators of the benefits of Targeted-
PCST. Aim 3: Evaluate the impact of Targeted-PCST on pain sensitivity and central sensitization, and explore
whether changes in these variables mediate group differences in pain severity and interference.
摘要
乳腺癌手术后持续疼痛越来越被认为是一个重要的临床和公众问题。
健康问题,由于大量的妇女受到影响,强大的负面影响,持续的疼痛有
情绪和身体功能及其经济成本。超过25万人中的大部分
今年,美国新诊断出乳腺癌的妇女将接受手术,作为治疗的一部分。
治疗手术切除受影响乳房(乳房切除术)后持续疼痛的患病率,
更有限的手术(乳房肿瘤切除术)比例较高,在所有研究中为25-60%。与急性术后不同,
疼痛是对手术创伤的正常反应,手术部位或附近的持续疼痛具有
不确定的多方面病因,没有令人满意的药物治疗。一个关键问题是,
关键的疼痛相关心理社会因素是持续性疼痛的持续负担的驱动因素,
可以通过非药物干预来改善。该奖项计划的研究将提供
对乳腺癌后持续性疼痛中疼痛灾难化的假设驱动作用的第一个关键测试
手术它还将探讨其他两个可能导致负担的关键心理社会变量的作用
与乳腺癌手术后持续疼痛相关:从事有价值活动的自我效能,
心理承受能力。我们已经开发,手册化,并试点测试疼痛应对技能培训
专门针对乳腺癌手术后持续疼痛妇女需求的干预措施
(有针对性的PCST),旨在减少痛苦灾难化,提高自我效能,
活动,降低心理承受能力。我们提出了一个多中心,随机临床试验,
评估靶向PCST干预的有效性。该研究将在9个不同的肿瘤学中进行
诊所:5家附属于杜克大学/杜克癌症网络,4家附属于杜克大学
匹兹堡/UPMC希尔曼癌症中心。受试者(N=564)将随机接受:1)
靶向PCST,2)一般健康教育干预(对照),或3)常规护理(对照)。参与者将
干预前和3个月(干预后)、6个月随访和12个月时的完整评估
个月随访。研究目的:目的1:检查靶向PCST对术后持续性
疼痛严重性和干扰(即,PEG评分)、情绪困扰(焦虑和抑郁)和癌症-
具体的苦恼。目的2:研究靶向PCST对疼痛灾难化、疼痛自我效能的影响,
和心理承受能力,并评估这些变量作为有针对性的益处的可能中介,
PCST。目的3:评价靶向PCST对疼痛敏感性和中枢致敏性的影响,并探讨
这些变量的变化是否介导了疼痛严重程度和干扰的组间差异。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
DANA H. BOVBJERG其他文献
DANA H. BOVBJERG的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('DANA H. BOVBJERG', 18)}}的其他基金
Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) with Mediational Analysis
乳房切除术后持续疼痛:针对性疼痛应对技能训练(Targeted-PCST)与中介分析的随机临床试验
- 批准号:
10381650 - 财政年份:2020
- 资助金额:
$ 61.95万 - 项目类别:
Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) with Mediational Analysis
乳房切除术后持续疼痛:针对性疼痛应对技能训练(Targeted-PCST)与中介分析的随机临床试验
- 批准号:
10132273 - 财政年份:2020
- 资助金额:
$ 61.95万 - 项目类别:
Experimental study of stress and DNA damage in humans: Mediators and moderators
人类压力和 DNA 损伤的实验研究:中介者和调节者
- 批准号:
9216858 - 财政年份:2017
- 资助金额:
$ 61.95万 - 项目类别:
Effects of psychological stress on DNA damage and repair in healthy BRCA1+ women
心理压力对健康 BRCA1 女性 DNA 损伤和修复的影响
- 批准号:
9206989 - 财政年份:2016
- 资助金额:
$ 61.95万 - 项目类别:
Breast Cancer Risk: Analysis of heightened HPA axis stress responsivity
乳腺癌风险:HPA 轴应激反应性升高的分析
- 批准号:
8307003 - 财政年份:2008
- 资助金额:
$ 61.95万 - 项目类别:
Breast Cancer Risk: Analysis of heightened HPA axis stress responsivity
乳腺癌风险:HPA 轴应激反应性升高的分析
- 批准号:
7686125 - 财政年份:2008
- 资助金额:
$ 61.95万 - 项目类别:
Breast Cancer Risk: Analysis of heightened HPA axis stress responsivity
乳腺癌风险:HPA 轴应激反应性升高的分析
- 批准号:
7895850 - 财政年份:2008
- 资助金额:
$ 61.95万 - 项目类别:
Breast Cancer Risk: Analysis of heightened HPA axis stress responsivity
乳腺癌风险:HPA 轴应激反应性升高的分析
- 批准号:
8119395 - 财政年份:2008
- 资助金额:
$ 61.95万 - 项目类别:
Breast Cancer Risk: Analysis of heightened HPA axis stress responsivity
乳腺癌风险:HPA 轴应激反应性升高的分析
- 批准号:
7461105 - 财政年份:2008
- 资助金额:
$ 61.95万 - 项目类别:
Evaluating the effects of stress on spontaneous tumor development: A new paradigm
评估压力对自发性肿瘤发展的影响:一个新范式
- 批准号:
7473228 - 财政年份:2007
- 资助金额:
$ 61.95万 - 项目类别:
相似海外基金
Rational design of rapidly translatable, highly antigenic and novel recombinant immunogens to address deficiencies of current snakebite treatments
合理设计可快速翻译、高抗原性和新型重组免疫原,以解决当前蛇咬伤治疗的缺陷
- 批准号:
MR/S03398X/2 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Fellowship
CAREER: FEAST (Food Ecosystems And circularity for Sustainable Transformation) framework to address Hidden Hunger
职业:FEAST(食品生态系统和可持续转型循环)框架解决隐性饥饿
- 批准号:
2338423 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Continuing Grant
Re-thinking drug nanocrystals as highly loaded vectors to address key unmet therapeutic challenges
重新思考药物纳米晶体作为高负载载体以解决关键的未满足的治疗挑战
- 批准号:
EP/Y001486/1 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Research Grant
Metrology to address ion suppression in multimodal mass spectrometry imaging with application in oncology
计量学解决多模态质谱成像中的离子抑制问题及其在肿瘤学中的应用
- 批准号:
MR/X03657X/1 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Fellowship
CRII: SHF: A Novel Address Translation Architecture for Virtualized Clouds
CRII:SHF:一种用于虚拟化云的新型地址转换架构
- 批准号:
2348066 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Standard Grant
The Abundance Project: Enhancing Cultural & Green Inclusion in Social Prescribing in Southwest London to Address Ethnic Inequalities in Mental Health
丰富项目:增强文化
- 批准号:
AH/Z505481/1 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Research Grant
ERAMET - Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
ERAMET - 快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10107647 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
EU-Funded
BIORETS: Convergence Research Experiences for Teachers in Synthetic and Systems Biology to Address Challenges in Food, Health, Energy, and Environment
BIORETS:合成和系统生物学教师的融合研究经验,以应对食品、健康、能源和环境方面的挑战
- 批准号:
2341402 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Standard Grant
Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10106221 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
EU-Funded
Recite: Building Research by Communities to Address Inequities through Expression
背诵:社区开展研究,通过表达解决不平等问题
- 批准号:
AH/Z505341/1 - 财政年份:2024
- 资助金额:
$ 61.95万 - 项目类别:
Research Grant