Improving Outcomes in Early Menopause After Cancer

Официальное название

Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention

Обзор

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: 1. Is the program easy to join, engaging, and well-received by participants? 2. 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.

Подробное описание

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.

Вмешательства

• Поведенческое Nurse Navigator Intervention
  The intervention will integrate education, decision support, patient activation strategies, and cognitive-behavioral menopause symptom management skills. Participants will receive video and audio-recorded materials and a written manual.
• Другое Education Control
  The control arm will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.

Первичные конечные точки

• Feasibility: Enrollment [Срок оценки: 10 months]
• Feasibility: Attrition [Срок оценки: 10 weeks]
• Feasibility: Use of intervention strategies [Срок оценки: 10 weeks]
• Acceptability: Treatment Acceptability Questionnaire [Срок оценки: 10 weeks]
• Acceptability: Client Satisfaction Questionnaire [Срок оценки: 10 weeks]

Вторичные конечные точки (9)

• Change in risk-based knowledge [Срок оценки: Baseline, 10 weeks]
• Change in symptom severity and interference: menopause symptoms [Срок оценки: Baseline, 10 weeks]
• Change in symptom severity and interference: anxiety [Срок оценки: Baseline, 10 weeks]
• Change in symptom severity and interference: depression [Срок оценки: Baseline, 10 weeks]
• Change in symptom severity and interference: illness intrusiveness [Срок оценки: Baseline, 10 weeks]
• Change in decisional conflict [Срок оценки: Baseline, 10 weeks]
• Change in self-efficacy: decision self-efficacy [Срок оценки: Baseline, 10 weeks]
• Change in self-efficacy: self-efficacy for managing symptoms [Срок оценки: Baseline, 10 weeks]
• Change in patient activation [Срок оценки: Baseline, 10 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Duke Cancer Institute — Durham

Идентификаторы

NCT: NCT06982677 · Pro00117811 · 1R21CA301298-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗