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

卷须：针对癌症后女性性功能障碍的多媒体干预

• 批准号: 7155611
• 负责人: LESLIE Ruth SCHOVER
• 金额: $ 11.93万
• 依托单位: AXIS HEALTHCARE COMMUNICATIONS, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-07 至 2008-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7155611
• 关键词: clinical research; counseling; female; neoplasm /cancer; self help

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.

性功能障碍是癌症治疗最常见的长期后果，影响了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女性。然而，很少有女性在性问题上得到所需的帮助。我们的主要目标是为癌症相关性功能障碍的女性开发和评估多媒体干预计划。卷须：癌症幸存妇女性更新计划将：1）解释癌症相关性功能障碍的原因; 2）提供自助策略以预防或克服问题; 3）建议妇女寻求适当的医疗帮助; 4）可能作为咨询计划的核心，沿着治疗师手册。Tendrils针对的是癌症部位的广泛受众，从新诊断的患者到长期幸存者。材料将敏感地反映对性的宗教和文化态度。动画将说明解剖学和生理学。该软件将允许女性以各种格式使用卷须：通过互联网，在光盘上，打印出来，或下载数字视频或音频在手持电脑或媒体播放器上。视频短片将说明问题和战略。4名女性癌症幸存者将主持该节目，分享他们的经验。研究设计和方法：在第一阶段，卷须的原型将被创建，包括文本，样本动画概念，和脚本的小插曲。10名专家和癌症倡导者将在网站上查看原型，3个女性幸存者焦点小组也将查看原型。如果至少有75%的人认为Tendrils符合评估表上易用性、可理解性和相关性的标准，则表明其可行性。在第二阶段，将创建修订后的完整Tendrils原型。我们将招募240名女性，1-5年的乳腺癌或妇科癌症幸存者，无疾病，并关闭积极的癌症治疗。将女性随机分配至2个治疗组，平衡癌症部位、年龄组、绝经状态和教育水平。自助小组将在网站上访问卷须12周。咨询小组将访问该网站12周，并与训练有素的咨询师一起参加3次会议。女性将在基线、治疗后以及3个月和6个月随访时完成在线问卷。使用网站的时间将被记录下来，女性将估计每周花在阅读课本、使用下载文件或做行为作业上的时间。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下使用，卷须都会显着改善性功能和满意度，但咨询小组的改善程度将显着高于自助小组。次要的假设是，咨询将增加更多的好处，教育程度较低的妇女和老年妇女。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Tendrils的最佳营销目标。项目相关性：与癌症治疗有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，以及较小但重要的比例的其他恶性肿瘤治疗的女性，例如在美国至少有300万女性。与其他社会心理困扰的来源相反，性功能障碍在癌症治疗后长期存在，并且通常是普遍的，降低性欲并影响亲密关系。虽然这些问题的原因是众所周知的，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种信息或服务。