Efficacy of a Couple-focused, Tailored, Symptom Self-Management mHealth Intervention for Prostate Cancer Patients and Partners

项目摘要/摘要 2016年，将有超过18万男性被诊断为局限性前列腺癌，其中92%的男性将患有局限性前列腺癌或前列腺癌 区域性疾病。幸运的是，有治疗意图的治疗(手术或放射治疗加/不加激素治疗)提供了 长期无癌生存。然而，幸存者会出现尿路、性、肠道和荷尔蒙症状，一般 痛苦、疼痛、疲劳和睡眠障碍。对于亲密关系中的男性来说，这些症状会扰乱夫妻的 关系和亲密关系，并降低患者及其主要伴侣的生活质量(QOL 照顾者。症状效应对伴侣的生活质量的影响可能与对患者自身的影响一样大，甚至更大。 对癌症及其治疗的负面影响的管理是一项明显未得到充分解决的支持性护理需求 这些人和他们的亲密伴侣。大多数现有的在线课程并不是以情侣为重点的，或者使用的是广义的“一刀切” 没有改善生活质量的“万能”方法。现有的面对面的情侣计划费用昂贵 而且因为所需的时间和旅行而不方便。为了解决这些未得到满足的支持性护理需求，宋博士领导了一项 跨学科团队开发和试点测试以证据为基础、以夫妇为重点、量身定做的 移动健康(MHealth)干预，“前列腺癌夫妇教育和资源”(PERC)。基于 PERC采用了压力应对理论框架，并在利益相关者的参与下开发，旨在改善生活质量 通过提高积极评价、自我效能感、社会支持和健康行为，为患者和伴侣提供帮助 用于症状管理。使用mHealth技术，PERC提供全面、用户友好的内容，并使用 量身定制和个性化功能，旨在提高PERC的个人相关性和夫妇的可访问性 模块。我们建议严格测试PERC的有效性，使用基于人口、地理和 随机对照试验中人口统计学上不同的队列。具体目标是：主要目标：评估患者是否 接受PERC的伴侣报告说，他们的癌症相关生活质量得分比对照组有更大的改善 组(常规护理加上国家癌症研究所(NCI)前列腺癌网站)在基线后4、8和12个月。 次要目标：测试PERC的患者和伴侣是否会报告更多的积极评价和更高的水平 在随访期应对资源的使用情况明显优于对照组。探索性目标：确定患者的种族和 种族、教育、治疗类型或夫妻关系质量调节PERC对患者和 后续行动中的合作伙伴生活质量。这项研究将为自我管理慢性疾病症状提供一种新的模式 夫妻关系、亲密关系和生活质量。它满足了国家护理研究所(NINR)的目标 开发和测试症状自我管理的新策略，帮助患者和照顾者更好地管理他们的疾病 改善生活质量。它还响应了医学研究所(IOM)和美国癌症研究所的呼吁 与美国癌症学会(ACS)合作，解决治疗相关影响，改善幸存者的生活质量。

PROJECT SUMMARY/ABSTRACT Over 180,000 men will be diagnosed with localized prostate cancer in 2016 and 92% of these men will have localized or regional disease. Fortunately, treatment with curative intent (surgery or radiation with/without hormone therapy) provides long-term cancer-free survival. However, survivors experience urinary, sexual, bowel and hormonal symptoms, general distress, pain, fatigue, and sleep disturbance. For men in an intimate relationship, these symptoms disrupt couple’s relationships and intimacy, and reduce quality of life (QOL) of both patients and their partners who are often their primary caregivers. Symptom effects may have as great or greater impact on their partners’ QOL than on patients’ own QOL. Management of the negative effects of cancer and its treatment is a significantly under-addressed supportive care need for these men and their intimate partners. Most existing online programs are not couple-focused or use generalized “one-size fits all” approaches that have fallen short of improving QOL. Existing in-person couple-focused programs are expensive and inconvenient because of the time and travel required. To address these unmet supportive care needs, Dr. Song led an interdisciplinary team to develop and pilot test the usability and feasibility of an evidence-based, couple-focused, tailored mobile health (mHealth) intervention, “Prostate Cancer Education & Resources for Couples” (PERC). Based on the adapted stress-coping theoretical framework and developed with stakeholder involvement, PERC aims to improve QOL for both patients and partners through enhancing positive appraisals, self-efficacy, social support, and healthy behaviors for symptom management. Using mHealth technologies, PERC provides comprehensive, user-friendly content, and uses tailoring and personalization features designed to increase personal relevance of, and couples’ accessibility to PERC modules. We propose to rigorously test the efficacy of PERC using a population-based, geographically and demographically diverse cohort in a randomized controlled trial. The specific aims are: Primary Aim: Assess if patients and partners receiving PERC will report greater improvement in their cancer-related QOL scores than those in the control group (usual care plus the National Cancer Institute (NCI) prostate cancer website) at 4, 8, and 12 months post-baseline. Secondary Aim: Test if patients and partners in PERC will report significantly more positive appraisals and higher levels of coping resources at follow-ups than those in the control group. Exploratory Aim: Determine if patient race and ethnicity, education, type of treatment, or couples’ relationship quality moderate the effects of PERC on patient and partner QOL at follow-ups. This study will provide a novel model for self-managing chronic illness symptoms that impact couples’ relationships, intimacy, and QOL. It addresses the National Institute of Nursing Research’s (NINR) goal to develop and test new strategies for symptom self-management to help patients and caregivers better manage their illness and improve QOL. It also responds to calls for programs from the Institute of Medicine (IOM) and American Cancer Society (ACS) to address treatment-related effects and improve survivors’ QOL.