Improving Outcomes in Early Menopause After Cancer

Duke University

Status: Begins enrollment in 1 month

Conditions: Early Menopause; Cancer

Treatments: Behavioral: Nurse Navigator Intervention; Other: Education Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06982677

Pro00117811

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Behavioral Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Nurse Navigator Intervention

Education Control

Other group

Description:

Participants will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.

Treatment:

Other: Education Control