Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Feasibility: Enrollment
研究概览
简要总结
The goal of this study is to create and test a new program led by nurse navigators to help women who experience early menopause after cancer. The program includes personalized menopause education, decision support, and skills to manage menopause symptoms.
The main questions it aims to answer are:
- Is the program easy to join, engaging, and well-received by participants?
- Does the program group show greater improvements in knowledge, decision-making, confidence, and menopause symptom management compared to the control group?
Participants will complete sessions of either the program being tested or an educational control program with a nurse navigator via video. Participants will also complete questionnaires when they start the study and again about 10 weeks later.
详细描述
The study aims to develop and pilot test a novel nurse navigator-delivered intervention for women experiencing premature and early menopause after cancer. The proposed intervention integrates 1) personalized, risk-based menopause health education and decision support, 2) skills derived from patient activation theory to increase self-efficacy and engagement in menopause self-management, and 3) cognitive-behavioral theory-based skills (e.g., stress management, relaxation techniques, challenging unhelpful thoughts, and activity pacing) for menopause symptom management.
Phase I: Develop and refine an intervention for women experiencing premature or early menopause after cancer. The intervention content will be developed and refined with input and review by women cancer survivors experiencing premature or early menopause (N=24) and medical providers (N=24) who care for this population. The intervention will be further refined with input and review by our study advisory council. Next, user testing (N=9) will be conducted to guide further refinement of content, format and procedures and to obtain feedback for finalizing the intervention protocol that will then be tested in a small pilot randomized controlled trial.
Phase II: Pilot randomized controlled trial (RCT) to examine the feasibility and acceptability of the developed intervention. A new sample of female cancer survivors experiencing premature or early menopause will be randomized to receive the intervention or educational materials for cancer survivors developed by the National Cancer Institute (NCI) to examine the feasibility of study recruitment, participant retention and acceptability.
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
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female (biological sex);
- •18 to 44 years old;
- •completed cancer treatment (other than endocrine therapy) >12 months prior to enrollment;
- •have not had a period for more than 12 months (amenorrhea);
- •able to speak and read English.
排除标准
- •diagnosis of metastatic cancer;
- •visual or hearing impairment that would interfere with participation in study;
- •cognitive impairment or severe mental illness that would interfere with participation in study.
研究组 & 干预措施
Behavioral Intervention
Participants will engage in a 6-session program, to be delivered by a nurse navigator in an individual therapy setting, via telehealth. The program will integrate education, decision support, patient activation strategies, and cognitive-behavioral menopause symptom management skills.
干预措施: Nurse Navigator Intervention (Behavioral)
Education Control
Participants will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.
干预措施: Education Control (Other)
结局指标
主要结局
Feasibility: Enrollment
时间窗: 10 months
Feasibility will be assessed by examining trial enrollment over the course of 10 months. The trial will be considered feasible if the study enrolls N=60 participants in 10 months, or 100% of the enrollment goal within 10 months. Thus, enrollment will be assessed by measuring the percentage of the enrollment goal at the end of 10 months.
Feasibility: Attrition
时间窗: 10 weeks
Feasibility will be assessed by examining attrition. Attrition will be measured by the percentage of participants who drop out of the study. The intervention will be considered feasible if \>80% of participants complete 6 sessions.
Feasibility: Use of intervention strategies
时间窗: 10 weeks
Feasibility will be assessed by examining participants' use of intervention strategies using a novel measure adapted for this study. Participants will be asked how often they have used the strategies presented in the intervention, with responses ranging from 0 ("Not at all") to 5 ("Every day"). Participants will also be asked about how often they have used each individual strategy or skill with responses ranging from 0 ("Not at all") to 4 ("6 or more days/week"). The intervention will be considered feasible if ≥75% of participants report use of intervention skills.
Acceptability: Treatment Acceptability Questionnaire
时间窗: 10 weeks
Acceptability will be assessed using the Treatment Acceptability Questionnaire (TAQ). The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable"). The intervention will be considered acceptable if \>80% of participants rate the intervention as \>5 out of 7 on the TAQ.
Acceptability: Client Satisfaction Questionnaire
时间窗: 10 weeks
Acceptability will be assessed using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item self-report scale to assess participant satisfaction; each item on this scale is scored from 1 to 4, with higher scores indicating higher satisfaction. The intervention will be considered acceptable if \>80% of participants rate the intervention as \>3 out of 4 on the CSQ.
次要结局
- Change in risk-based knowledge(Baseline, 10 weeks)
- Change in symptom severity and interference: menopause symptoms(Baseline, 10 weeks)
- Change in symptom severity and interference: anxiety(Baseline, 10 weeks)
- Change in symptom severity and interference: depression(Baseline, 10 weeks)
- Change in symptom severity and interference: illness intrusiveness(Baseline, 10 weeks)
- Change in decisional conflict(Baseline, 10 weeks)
- Change in self-efficacy: decision self-efficacy(Baseline, 10 weeks)
- Change in self-efficacy: self-efficacy for managing symptoms(Baseline, 10 weeks)
- Change in patient activation(Baseline, 10 weeks)