The Sexual Rehabilitation of Rectal Cancer Survivors: A Pilot Study

直肠癌幸存者的性康复：一项试点研究

• 批准号: 7492165
• 负责人: KATHERINE N DUHAMEL
• 金额: $ 22.44万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7492165
• 关键词: Address; Adopted; American Cancer Society; Appointment; Cancer Etiology; Cancer Patient; Cancer Survivor; Cancer Survivorship; Caring; Cessation of life; Clinical; Clinical Trials; Colon Carcinoma; Colorectal Cancer; Condition; Continuance of life; Data; Development; Diagnosis; Distress; Dyspareunia; Education; Educational Intervention; Effectiveness; Ensure; Evaluation; Female; Focus Groups; Frequencies; Goals; Income; Intervention; Lead; Life; Malignant Neoplasms; Medical; Memorial Sloan-Kettering Cancer Center; Numbers; Operative Surgical Procedures; Orgasm; Outcome; Outcome Study; Outpatients; Participant; Patients; Pilot Projects; Problem Solving; Prospective Studies; Protocols documentation; Public Health; Purpose; Quality of life; Radiation; Randomized; Randomized Controlled Trials; Rectal Cancer; Recurrence; Rehabilitation therapy; Reporting; Research; Research Personnel; Self Concept; Sex Behavior; Sex Functioning; Sexual Health; Staging; Stomas; Survivors; Symptoms; Target Populations; Techniques; Telephone; Testing; Therapeutic; Time; Total Mesorectal Excision; Upper arm; Week; Woman; base; cancer therapy; chemotherapy; coping; cost; design; early /brief intervention /therapy; follow-up; improved; marital age; member; novel; novel strategies; preference; psychoeducational intervention; satisfaction; therapy design; therapy development

DESCRIPTION (provided by applicant): Over 18,350 cases of rectal cancer (RC) will be diagnosed in women in 2006. Therapy for RC has rapidly improved with advances in surgical techniques resulting in improved survival and decreased local recurrence over the last 20 years. As a result survivorship issues have become increasingly important. A troubling issue is that sexual function in women after RC therapy is significantly impaired. The goal of the proposed study is to develop and pilot a novel, sexual health focused intervention designed to enhance female RC survivorship entitled, "Cancer Survivorship Intervention-Sexual Rehabilitation (CSI-SR). CSI-SR is designed to reduce sexual problems based on the needs and preferences of female RC survivors. This early stage study will feature a randomized controlled trial (RCT) with 116 RC survivors stratified and randomly assigned to one of two conditions: 1) CSI-SR plus usual care (UC) or 2) UC only. Patients assigned to CSI-SR +UC will receive four face-to-face bimonthly sessions of this novel intervention. Each session focuses on different topics including education about the impact of RC treatment on sexual health, general distress coping strategies and specific strategies to increase sexual health (senate focus). Each session also includes homework assignments to be completed within the intervening week. In addition, the first three face-to-face sessions are followed by a booster/trouble shooting telephone session to help participants enact the strategies and problem solve any barriers to implementation. These booster phone calls will serve as reminders for strategy practice. Regardless of assignment to condition, all participants will be assessed three times, at baseline and then again two and four months post-baseline. The purpose of the proposed pilot RCT is threefold: 1) To investigate the feasibility, tolerability, acceptability, and promise of CSI-SR on the primary outcome of RC survivors sexual functioning; 2) To investigate the impact of CSI-SR on secondary outcomes: sexual self concept, cancer specific distress, general distress, and quality of life; and 3) To explore variables that may influence the effectiveness of CSI-SR (i.e., moderators). Information from this pilot study will inform the use of interventions to increase sexual health among RC survivors. This study has high translational promise. If CSI-SR is found to be efficacious, it could be easily adopted into clinical care. Prior to conducting the pilot RCT, three focus groups will be conducted with 10 RC survivors each. Focus Groups have been found by members of the research team and prior researchers to be an excellent way to inform intervention development to ensure that the intervention is matched to the needs to the target population. The three focus groups will ensure that CSI- SR is targeted to the needs and preferences of RC survivors. to public health Although life saving, Rectal Cancer (RC) treatment can have a high cost to survivors in regard to their sexual health. Colorectal cancer is the third leading cause of cancer death. Although RC survivors may be fewer in number than colon cancer survivors, our research has suggested that female RC survivors suffer more sexual health problems as compared to female colon cancer survivors. CSI-SR is deigned to address this significant survivorship issues by providing a brief intervention to promote sexual health designed for RC survivors based on their needs and preferences.

描述（由申请人提供）：2006年，将有超过18，350例女性直肠癌（RC）确诊病例。在过去的20年里，随着手术技术的进步，RC的治疗得到了迅速改善，从而提高了生存率并减少了局部复发。因此，生存问题变得越来越重要。一个令人不安的问题是，RC治疗后女性的性功能明显受损。这项研究的目的是开发和试验一种新的，以性健康为重点的干预措施，旨在提高女性RC生存率，名为“癌症生存干预-性康复（CSI-SR）”。CSI-SR旨在根据女性RC幸存者的需求和偏好减少性问题。这项早期研究将采用随机对照试验（RCT），116名RC幸存者分层并随机分配至两种情况之一：1）CSI-SR+常规治疗（UC）或2）仅UC。分配到CSI-SR +UC的患者将接受四次面对面的双月一次的新型干预。每次会议侧重于不同的主题，包括关于RC治疗对性健康的影响的教育，一般的痛苦应对策略和提高性健康的具体策略（参议院重点）。每节课还包括在中间一周内完成的家庭作业。此外，前三次面对面会议之后是一个助推器/解决问题的电话会议，以帮助参与者制定战略和解决任何实施障碍。这些助推器电话将作为战略实践的提醒。无论病情如何分配，所有参与者都将在基线时评估三次，然后在基线后两个月和四个月再次评估。该试验性随机对照试验的目的有三个：1）研究CSI-SR对RC幸存者性功能主要结局的可行性、耐受性、可接受性和承诺; 2）研究CSI-SR对次要结局的影响：性自我概念、癌症特异性痛苦、一般痛苦和生活质量;和3）探索可能影响CSI-SR有效性的变量（即，主持人）。这项试点研究提供的信息将有助于采取干预措施，提高难民署幸存者的性健康水平。这项研究具有很高的翻译前景。如果CSI-SR被发现是有效的，它可以很容易地被采用到临床护理。在进行试点随机对照试验之前，将进行三个重点小组，每个小组有10名难民救济委员会幸存者。研究小组成员和先前的研究人员发现，焦点小组是一种很好的方式，可以为制定干预措施提供信息，以确保干预措施与目标人群的需求相匹配。这三个重点小组将确保CSI- SR针对驻地协调员幸存者的需要和偏好。直肠癌治疗虽然可以挽救生命，但在性健康方面，对幸存者来说成本很高。结直肠癌是癌症死亡的第三大原因。虽然RC幸存者的数量可能少于结肠癌幸存者，但我们的研究表明，女性RC幸存者比女性结肠癌幸存者遭受更多的性健康问题。CSI-SR旨在解决这一重大的生存问题，根据RC幸存者的需求和偏好提供简短的干预措施，以促进他们的性健康。

项目成果

Barriers to participation in a sexual health intervention for men following treatment for rectal and anal cancer.

• DOI: 10.1002/pon.4593
• 发表时间: 2018-03
• 期刊: Psycho-oncology
• 影响因子: 3.6
• 作者: Shaffer KM;Nelson CJ;DuHamel KN
• 通讯作者: DuHamel KN

Body image and sexual function in women after treatment for anal and rectal cancer.

• DOI: 10.1002/pon.3847
• 发表时间: 2016-03
• 期刊: Psycho-oncology
• 影响因子: 3.6
• 作者: Benedict C;Philip EJ;Baser RE;Carter J;Schuler TA;Jandorf L;DuHamel K;Nelson C
• 通讯作者: Nelson C

Psychological correlates of sexual dysfunction in female rectal and anal cancer survivors: analysis of baseline intervention data.

女性直肠癌和肛门癌幸存者性功能障碍的心理相关性：基线干预数据分析。

• DOI: 10.1111/jsm.12152
• 发表时间: 2013
• 期刊: The journal of sexual medicine
• 作者: Philip,ErrolJ;Nelson,Christian;Temple,Larissa;Carter,Jeanne;Schover,Leslie;Jennings,Sabrina;Jandorf,Lina;Starr,Tatiana;Baser,Ray;DuHamel,Katherine
• 通讯作者: DuHamel,Katherine

Reduction in social activities mediates the relationship between diarrhea and distress in rectal/anal cancer survivors.

社交活动的减少调节了直肠/肛门癌幸存者腹泻和痛苦之间的关系。

• DOI: 10.1002/pon.4486
• 发表时间: 2018
• 期刊: Psycho-oncology
• 影响因子: 3.6
• 作者: Benedict,Catherine;DuHamel,Katherine;Nelson,ChristianJ
• 通讯作者: Nelson,ChristianJ

The sexual health of female rectal and anal cancer survivors: results of a pilot randomized psycho-educational intervention trial.

• DOI: 10.1007/s11764-015-0501-8
• 发表时间: 2016-06
• 期刊: Journal of cancer survivorship : research and practice
• 作者: DuHamel K;Schuler T;Nelson C;Philip E;Temple L;Schover L;Baser RE;Starr TD;Cannon K;Jennings S;Jandorf L;Carter J
• 通讯作者: Carter J