Tendrils: A Multimedia Intervention for Women's Sexual Dysfunction after Cancer

描述（由申请人提供）：长期目标目的：性功能障碍是癌症治疗最常见的长期后果，影响着一半的乳腺癌和妇科癌症幸存者以及许多接受其他癌症治疗的妇女。然而，很少有女性在性问题上得到她们需要的帮助。我们的主要目标是开发和评估一个多媒体干预程序的妇女与癌症相关的性功能障碍。卷须：一项针对癌症幸存女性的性更新计划将：1)解释癌症相关性功能障碍的原因；2)提供自助策略来预防或克服问题；3)建议妇女寻求适当的医疗帮助；4)可能作为咨询项目的核心，连同治疗师手册一起。Tendrils针对的是广泛的受众，从新诊断到长期幸存者，跨越癌症部位。材料将呈现敏感的宗教和文化对性的态度。动画将说明解剖学和生理学。这款软件将允许女性以多种形式使用卷茎：通过互联网、CD-Rom、打印出来，或者在掌上电脑或媒体播放器上下载数字视频或音频。视频短片将说明问题和策略。4位女性癌症幸存者将主持这个节目，分享她们的经历。研究设计和方法：在第一阶段，将创建一个卷须的原型，包括文本，动画概念样本和小插图的脚本。10位专家和癌症倡导者将在一个网站上观看原型，还有3个女性幸存者焦点小组。如果至少75%的卷须在评估表格上符合易用性、可理解性和相关性的标准，则表明其可行性。在第二阶段，将创建一个经过修订的完整的卷须原型。我们将招募240名妇女，她们是乳腺癌或妇科癌症1-5年的幸存者，没有疾病，没有接受过积极的癌症治疗。妇女将被随机分为两个治疗组，根据癌症部位、年龄、更年期状况和教育水平进行治疗。自助小组将在一个网站上访问Tendrils，为期12周。咨询小组将访问该网站12周，并与受过培训的咨询师一起参加3次会议。妇女将在基线、治疗后以及3个月和6个月的随访期间完成在线问卷调查。使用网站的时间将被记录下来，女性将估计每周阅读打印输出、使用下载文件或做行为作业的时间。我们的主要假设是，无论是在自助的基础上还是在简短的咨询中，卷须都能显著改善性功能和满意度，但咨询小组的改善效果要比自助小组明显得多。第二种假设是，咨询将为受教育程度较低的妇女和老年妇女带来更多好处。使用卷须所花费的时间将被视为成功的潜在中介。试验结果将用于卷须的最佳目标营销。项目相关性：与癌症治疗相关的性问题影响了大约一半的乳腺癌或盆腔癌女性幸存者，以及一小部分但重要的其他恶性肿瘤女性幸存者，例如，美国至少有300万女性。与其他社会心理困扰的来源不同，性功能障碍在癌症治疗后长期存在，通常普遍存在，减少性欲，影响亲密关系。虽然这些问题的原因是已知的，而且简短的咨询往往能有效地解决这些问题，但很少有妇女能获得这些信息或服务。

DESCRIPTION (provided by applicant): Long-term Objectives Aims: Sexual dysfunction is the most common long-term consequence of cancer treatment, affecting half of survivors of breast and gynecological cancer and many women treated for other cancers. Yet, few women get the help they need for sexual problems. Our primary objective is to develop and evaluate a multimedia intervention program for women with cancer-related sexual dysfunction. Tendrils: A Sexual Renewal Program for Women Surviving Cancer will: 1) explain the causes of cancer-related sexual dysfunction; 2) offer self-help strategies to prevent or overcome problems; 3) advise women on seeking appropriate medical help; and 4) possibly serve as the core of a counseling program, along with a therapist manual. Tendrils is aimed at a wide audience, from newly diagnosed to long-term survivors, across cancer sites. Material will be presented with sensitivity to religious and cultural attitudes about sexuality. Animations will illustrate anatomy and physiology. The software will let women use Tendrils in a variety of formats: over the internet, on a CD-Rom, printed out, or as downloaded digital video or audio on a handheld computer or media player. Video vignettes will illustrate problems and strategies. 4 female cancer survivors will host the program, sharing their experiences. Research Design and Methods: In Phase I, a prototype of Tendrils will be created including text, sample animation concepts, and scripts of vignettes. 10 expert professionals and cancer advocates will view the prototype on a website, as will 3 focus groups of female survivors. Feasibility will be shown if at least 75% rate Tendrils as meeting criteria for ease of use, comprehensibility, and relevance on an evaluation form. In Phase II, a revised, complete prototype of Tendrils will be created. We will recruit 240 women, 1-5-year survivors of breast or gynecological cancer, free of disease, and off active cancer treatment. Women will be randomized to 2 treatment groups, balancing cancer site, age group, menopausal status, and educational level. The self-help group will access Tendrils on a website for a 12-week period. The counseling group will access the website for 12 weeks and attend 3 sessions with a trained counselor. Women will complete online questionnaires at baseline, after treatment, and at 3-and 6-month follow-up. Time spent using the website will be recorded and women will estimate time spent weekly reading printouts, using downloaded files, or doing behavioral homework. Our primary hypothesis is that Tendrils will produce significant improvements in sexual function and satisfaction whether used on a self-help basis or with brief counseling, but that the counseling group will improve significantly more than the self-help group. Secondary hypotheses are that counseling will add more benefit for less educated women and older women. Time spent using Tendrils will be examined as a potential mediator of success. Trial outcome will be used to target marketing of Tendrils optimally. Project Relevance: Sexual problems related to cancer treatment affect approximately half of female survivors of breast or pelvic cancer and a smaller, but significant, proportion of women treated for other malignancies, e.g. at least 3 million women in the United States. In contrast to other sources of psychosocial distress, sexual dysfunction persists long after cancer treatment and is usually pervasive, diminishing sexual desire and affecting intimacy. Although the causes of these problems are known, and brief counseling is often effective at resolving them, few women have access to such information or services.