Quality of Life for Couples Facing Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in Self-Reported Patient Sexual Function
研究概览
简要总结
The primary objectives of this study are to adapt and evaluate a sexual quality of life intervention in women with metastatic breast cancer and their partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is female
- •Patient is at least 18 years old
- •Patient has a diagnosis of metastatic (stage IV) breast cancer
- •Patient has a partner or spouse who is at least 18 years old
- •Patient lives with a romantic partner (same or opposite sex) for at least 6 months
- •Patient scores 3 or above on Patient Care Monitor sexual concerns item (range: 0-10)
排除标准
- •Patient or partner is not able to speak and read English
- •Patient or partner has a hearing impairment
- •Patient or partner medically unable to participate as judged by physician/in medical record or by self-report
- •Patient and partner do not have reliable telephone access
- •Patient has overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, physician or referring source, or self-report
- •Patient past or current history of any cancer other than non-melanoma skin cancer or breast cancer
- •Patient is currently participating in couple/marital therapy
- •Patient is currently pregnant
结局指标
主要结局
Change in Self-Reported Patient Sexual Function
时间窗: Baseline, 9 weeks, 6 months
Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.
Change in Self-Reported Patient Sexual Distress
时间窗: Baseline, 9 weeks, 6 months
Patient sexual distress will be measured using the 13-item Female Sexual Distress Scale-Revised (FSDS-R). Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress.
Change in Patient Self-Reported Self-Efficacy for Coping with Sexual Concerns
时间窗: Baseline, 9 weeks, 6 months
Patient self-efficacy for coping with sexual concerns will be measured using 3 items asking how certain the patient is that she can deal with issues related to physical intimacy. Scores range from 0 to 10, with higher scores indicating higher self-efficacy. Change in patient mean self-efficacy score over time will be reported, with a positive change score reflecting an increase in self-efficacy.
次要结局
- Change in Patient Self-Reported Intimacy-Related Communication(Baseline, 9 weeks, 6 months)
- Change in Patient Self-Reported Relationship Intimacy(Baseline, 9 weeks, 6 months)
- Change in Patient Self-Reported Anxiety(Baseline, 9 weeks, 6 months)
- Change in Patient Self-Reported Depressive Symptoms(Baseline, 9 weeks, 6 months)
- Change in Self-Reported Partner Sexual Function(Baseline, 9 weeks, 6 months)
- Change in Self-Reported Partner Sexual Distress(Baseline, 9 weeks, 6 months)
- Change in Partner Self-Reported Self-Efficacy for Coping with Sexual Concerns(Baseline, 9 weeks, 6 months)
- Change in Partner Self-Reported Intimacy-Related Communication(Baseline to 9 weeks)
- Change in Partner Self-Reported Relationship Intimacy(Baseline, 9 weeks, 6 months)
- Change in Partner Self-Reported Anxiety(Baseline, 9 weeks, 6 months)
- Change in Partner Self-Reported Depressive Symptoms(Baseline, 9 weeks, 6 months)