Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Feasibility of the Treatment as Measured Through Study Accrual
研究概览
简要总结
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years
- •Has diagnosis of non-recurrent stage I-III breast cancer
- •Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- •Has a partner or spouse who is > 21
- •Lives with a romantic partner > 6 months
- •Score of > 3 on Patient Care Monitor Sexual Concerns screening item
- •No hearing impairment in patient or partner
排除标准
- •Not able to speak English, as stated in medical record or as observed by study team member
- •ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- •Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- •Past history of any cancer other than non-melanoma skin cancer
- •Currently participating in couple/marital therapy
- •Currently pregnant
研究组 & 干预措施
Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
干预措施: Intimacy Enhancing Intervention (Behavioral)
Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
干预措施: Behavioral, Psychological or Informational Intervention (Behavioral)
Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
干预措施: Partner-Assisted Coping Skills Training (Behavioral)
Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
干预措施: Living Healthy Together (Behavioral)
结局指标
主要结局
Feasibility of the Treatment as Measured Through Study Accrual
时间窗: Up to 8 weeks
Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
Feasibility of the Treatment as Measured Through Study Attrition
时间窗: Up to 8 weeks
Feasibility of treatment is measured through the number of randomized participants who completed the study.
Feasibility of the Treatment as Measured Through Session Completion by Participant
时间窗: Up to 8 weeks
Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
时间窗: Up to 8 weeks
Acceptability was measured through the median score on a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate higher satisfaction with the service (acceptability). A median score of 28 or higher is considered acceptable. This measure was collected for both patients and partners.
次要结局
- Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)(Baseline to up to 8 weeks)
- Change in Sexual Function Measured Using the International Index of Erectile Function(Baseline to up to 8 weeks)
- Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items(Baseline to up to 8 weeks)
- Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised(Baseline to up to 8 weeks)
- Change in Beliefs (Self-efficacy)(Baseline to up to 8 weeks)
- Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale(Baseline to up to 8 weeks)
- Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item(Baseline to up to 8 weeks)
- Change in Body Image Distress Measured Using the Body Image Scale(Baseline to up to 8 weeks)
- Change in Depression Measured Using the Patient Health Questionnaire-9 Item(Baseline to up to 8 weeks)
- Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale(Baseline to up to 8 weeks)
- Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item(Baseline to up to 8 weeks)
- Change in Cancer-related Distress Using the Impact of Events Scale-Revised(Baseline to up to 8 weeks)