Patient-Centered Decision Counseling for Women at Risk of Cancer-Related Infertility: Efficacy Study and Comparative-Effectiveness Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Patients' decisional conflict (Part 1)
研究概览
简要总结
This trial studies how well a decision aid website works in helping to make decisions about fertility in participants with cancer. Decision aid websites that provide information about fertility preservation (maintaining your ability to have children of your own after cancer treatment) may help participants with cancer make fertility-preservation decisions.
详细描述
PRIMARY OBJECTIVES:
I. To assess the effect of the Pathways to Fertility patient decision aid website (DA website) with women of reproductive age seen at the MD Anderson Oncofertility Service, in terms of improving patients' decisional conflict. (Part 1) II. To assess the effect of a multicomponent oncofertility decision support intervention (multicomponent DS intervention) compared to usual care with women of reproductive age at selected MD Anderson Houston Area Locations (HALs) on patients' decisional conflict. (Part 2)
SECONDARY OBJECTIVES:
I. To assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision and/or treatment received). (Part 1) II. To assess patients' decision-making process (e.g., preparation for decision making, decision self-efficacy, satisfaction) and decision quality (e.g., fertility preservation knowledge, clarity of patients' values, and congruence of preferences with the decision about whether to accept fertility preservation referral and/or fertility preservation treatment). (Part 2)
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed breast tumor, female genital system tumor, colorectal tumor, and/or lymphoma/myeloma
- •At risk for cancer-related infertility, as assessed by their clinician(s), including the oncofertility specialist
- •Must be able to speak, read, and write English
- •Must have internet access and a valid email address
- •Have not previously viewed the Pathways decision aid
- •For clinical provider participants: Clinical provider at a Houston Area Location of MD Anderson assigned to the intervention
排除标准
- 未提供
研究组 & 干预措施
Arm I (standard of care)
Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.
干预措施: Best Practice (Other)
Arm I (standard of care)
Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.
干预措施: Educational Intervention (Other)
Arm I (standard of care)
Participants receive standard of care including education materials about fertility preservation from the Livestrong organization and a referral for fertility preservation, if requested.
干预措施: Questionnaire Administration (Other)
Arm II (standard of care, decision-making website)
Participants receive standard of care as in Arm I. Participants also use the decision-making the website.
干预措施: Best Practice (Other)
Arm II (standard of care, decision-making website)
Participants receive standard of care as in Arm I. Participants also use the decision-making the website.
干预措施: Educational Intervention (Other)
Arm II (standard of care, decision-making website)
Participants receive standard of care as in Arm I. Participants also use the decision-making the website.
干预措施: Internet-Based Intervention (Other)
Arm II (standard of care, decision-making website)
Participants receive standard of care as in Arm I. Participants also use the decision-making the website.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Patients' decisional conflict (Part 1)
时间窗: Up to 2 months
Will assess the effect of the Pathways to Fertility patient decision aid website (DA website) with women of reproductive age seen at the MD Anderson Oncofertility Service, in terms of improving patients' decisional conflict.
Patients' decisional conflict (Part 2)
时间窗: Up to 2 months
Will assess the effect of a multicomponent oncofertility decision support intervention (multicomponent DS intervention) compared to usual care with women of reproductive age at selected MD Anderson Houston Area Locations (HALs) on patients' decisional conflict.
次要结局
- Patients' decision-making process (Part 1)(Up to 2 months)
- Patients' decision-making process (Part 2)(Up to 2 months)