Telephone Counseling: Men w/Prostate CA & Partners

描述（由申请人提供）：本初步研究的目的是对80名前列腺癌患者及其伴侣的生活质量（身体、心理、社会和精神健康）进行测试，并将电话人际咨询干预与注意力常规护理对照进行比较。目的1将检验电话人际咨询干预（TIP-C）与注意常规护理控制（UC）对前列腺癌患者及其伴侣的有效性：a)身体健康（疲劳、症状困扰和症状管理）b)心理健康（抑郁、焦虑和压力）c)社会健康（关系质量）和d)精神健康。目标2将描述那些对TIP-C干预反应积极的个人（癌症患者和伴侣）的人口统计学（如年龄、种族）和社会概况。减轻抑郁、负面影响、压力、焦虑、疲劳和症状困扰的症状，增加社会幸福感、症状管理、关系质量和精神幸福感)。第三个目标侧重于可行性问题（即解决电话提供干预措施的任何后勤问题）。目的4检查了相关的方法学问题（即，确定每种干预措施的效应大小差异、与治疗强度相关的剂量反应、达到预期结果所需的依从性水平）。本研究将采用随机分层实验设计，重复测量，比较8周TIP-C干预与8周UC干预在生活质量指标上的有效性。约80名患有前列腺癌的白人、非西班牙裔和西班牙裔男性及其伴侣（N=160）将被分配到TIP-C或UC，按阶段（IA至IV）分层。测量将进行五次：所有受试者在入组时基线（T1）、完成三周干预后（T2）、完成6周干预后（T3）、完成8周干预后（T4）和完成T4后两个月（T5），无论分组分配如何。数据将通过描述性统计、一系列双向混合设计方差分析和个体回归分析进行分析。

DESCRIPTION (provided by applicant): The purpose of this pilot study is to test a telephone-delivered interpersonal counseling intervention compared to an attentional usual care control on the effects of quality of life (physical, psychological, social and spiritual well-being) for 80 men with prostate cancer and their partners. Aim 1 will examine the effectiveness of the telephone interpersonal counseling intervention (TIP-C) compared to an attentional usual care control (UC) with men with prostate cancer and their partners' a) Physical well-being (fatigue, symptom distress and symptom management) b) Psychological well-being (depression, anxiety, and stress), c) Social Well-being (relationship quality) and d) Spiritual Well-Being. Aim 2 will describe the demographic (e.g., age, ethnicity) and social profiles of those individuals (person with cancer and partner) who respond positively to the TIP-C intervention, (e.g.. decreased symptoms of depression, negative affect, stress, anxiety, fatigue, and symptom distress and increased social well-being, symptom management, relationship quality and spiritual well-being). The third aim focuses on feasibility issues (i.e., to resolve any logistical issues of the telephone-delivered interventions). Aim 4 examines relevant methodological issues (i.e., determining the effect size differences for each intervention, dose- response associated with treatment strength, level of adherence needed for the desired outcomes). This study will use a randomized, stratified experimental design with repeated measures to compare the effectiveness of an 8 week TIP-C intervention with an 8-week UC on QOL indicators. About 80 white, non- Hispanic and Hispanic men with prostate cancer and their partners (N=160) will be assigned to either the TIP-C or UC, stratified by stage (IA to IV). Measurement will occur five times: At baseline upon enrollment (T1), after completing three weeks of the interventions (T2), after completing 6 weeks of the interventions (T3), after completing the 8-week interventions (T4) and two months after T4 (T5) for all subjects, regardless of group assignment. Data will be analyzed through descriptive statistics, a series of two-way mixed design ANOVAs and individual regression analyses.