117 Participants NeededMy employer runs this trial

Nurse Navigator Program for Menopause After Cancer

MW
SD
Overseen BySmrithi Divakaran, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to assist women experiencing early menopause after cancer. The Nurse Navigator Intervention, led by nurse navigators, provides personalized education and skills to manage menopause symptoms. Researchers aim to determine if this program is easy to join, engaging, and improves knowledge and confidence compared to a standard educational booklet. Women who completed cancer treatment over a year ago, have not had a period for more than 12 months, and can speak and read English may be suitable for this trial. Participants will join sessions via video and complete questionnaires at the start and end of the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions for women experiencing early menopause after cancer.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What prior data suggests that this program is safe for participants?

Research has shown that nurse navigator programs are generally well-liked and can safely assist patients. Studies have found that these programs can reduce stress in cancer patients. For instance, one study discovered that patients felt less anxious after receiving support from a nurse navigator. This indicates that these programs are not only safe but also beneficial.

Participants in these programs often receive personalized advice and information, which helps them manage their symptoms more effectively. No major problems have been reported in connection with nurse navigator support. This is encouraging for anyone considering joining a similar program, as it demonstrates that the approach is well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about the Nurse Navigator Intervention for managing menopause after cancer because it offers a personalized, telehealth-based approach that integrates multiple support strategies. Unlike traditional hormone replacement therapies or lifestyle advice, this intervention combines education, decision support, and cognitive-behavioral techniques tailored to each participant. This comprehensive and individualized method not only helps manage menopause symptoms but also empowers patients to take an active role in their health, offering a potentially more holistic and accessible solution for cancer survivors.

What evidence suggests that the Nurse Navigator Intervention is effective for managing menopause after cancer?

Research has shown that nurse navigator programs can help cancer patients feel better and less stressed. One study found that these programs, which support patients for 18 months, improved their well-being. Nurse-led care is safe and effective, resulting in better health outcomes and fewer emergency visits. Women in these programs often feel more informed and confident in managing menopause symptoms. In this trial, participants will engage in a nurse navigator program, which could benefit women experiencing early menopause after cancer.13678

Who Is on the Research Team?

RS

Rebecca Shelby, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for women who have gone through early menopause after cancer treatment (except ongoing hormone therapy), finished their cancer treatment over a year ago, haven't had a period in more than 12 months, and can speak and read English.

Inclusion Criteria

Have not had a period for more than 12 months (amenorrhea)
Able to speak and read English
I am biologically female.
See 2 more

Exclusion Criteria

Cognitive impairment or severe mental illness that would interfere with participation in study
Visual or hearing impairment that would interfere with participation in study
I have been diagnosed with cancer that has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Develop and refine an intervention for women experiencing premature or early menopause after cancer, including user testing and feedback refinement.

Not specified

Pilot Randomized Controlled Trial

Participants engage in a 6-session program delivered by a nurse navigator via telehealth, integrating education, decision support, and cognitive-behavioral skills.

10 weeks
6 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acceptability, feasibility, and changes in knowledge and symptom management.

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nurse Navigator Intervention

Trial Overview

The study compares a nurse-led program that offers personalized education and support for managing menopause symptoms to an educational control group. Both groups meet with a nurse via video sessions and complete questionnaires at the start and about 10 weeks later.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Education ControlExperimental Treatment1 Intervention
Group II: Behavioral InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Improving Outcomes in Early Menopause After Cancer

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.

development and pilot testing of a novel intervention

This study will develop and pilot test a novel nurse navigator-delivered intervention to help women make risk-based and values-driven menopause management ...

Improving Outcomes in Early Menopause After Cancer

Study Details. 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.

Patient Navigation Effect on Cancer Patients' Quality of Life ...

This investigation found that distress and QOL improved over a period of 18 months while patients were in a navigation program after a diagnosis of cancer.

Nurse-enabled survivorship in early-stage breast cancer ...

Evidence supports streamlined, nurse-enabled care as safe and effective, with PRO-integrated triage reducing emergency visits and improving outcomes.

The menopause after cancer study (MACS) - PMC - NIH

This study will aim to assess if a composite intervention which involves a specific evidence-based intervention for management of insomnia and non-hormonal ...

Improving Outcomes in Early Menopause After Cancer

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.

Where Fear Begins: The Effect of a Nurse Navigator Home ...

Conclusion: The findings suggest significantly decreased levels of distress in newly diagnosed breast cancer patients after receiving a home visit intervention ...