Early MenopauseNCT06982677
Improving Outcomes in Early Menopause After Cancer
A study testing Nurse Navigator Intervention in people with Early Menopause and Cancer, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Early Menopause, Cancer, Premature Menopause
- What is being tested?
- Nurse Navigator Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27705
Michael W Willis, 919-681-8437, michael.w.willis@duke.edu
Smrithi Divakaran, 919-681-7695, smrithi.divakaran@duke.edu
About this study
Official title: Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Early Menopause, Cancer, Premature Menopause, Surgical Menopause
- Being tested
- Nurse Navigator Intervention, Education Control
- Medical subject headings
- Primary Ovarian Insufficiency, Neoplasms, Menopause, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Navigator InterventionBehavioural
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.
Education ControlOther
The control arm will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | 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. Receives: Behavioral: Nurse Navigator Intervention |
| Education Control | Other | Participants will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship. Receives: Other: Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Enrollment
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.
Measured: 10 months
Feasibility: Attrition
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.
Measured: 10 weeks
Feasibility: Use of intervention strategies
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.
Measured: 10 weeks
Acceptability: Treatment Acceptability Questionnaire
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.
Measured: 10 weeks
Acceptability: Client Satisfaction Questionnaire
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.
Measured: 10 weeks
Secondary outcomes (9)
Change in risk-based knowledge
Knowledge will be assessed using an item pool developed for the study. Each participant will complete 10 items based on the risk-based education they received. Knowledge will be calculated as the percent of correct items (from 0% to 100%).
Measured: Baseline, 10 weeks
Change in symptom severity and interference: menopause symptoms
Symptom severity and interference will be measured via the Menopause Specific Quality of Life Questionnaire (MENQOL). The 32-item MENQOL assesses the degree of symptom interference in the past week related to four domains: physical symptoms, vasomotor symptoms, psychosocial symptoms, and sexual symptoms. For each symptom that a participant endorses, they will be asked to rate how much they have been bothered by the symptom on a 7-point scale from 0 ("Not at all bothered") to 6 ("Extremely bothered").
Measured: Baseline, 10 weeks
Change in symptom severity and interference: anxiety
Symptom severity and interference will be measured via the PROMIS® Anxiety 8-item Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always".
Measured: Baseline, 10 weeks
Change in symptom severity and interference: depression
Symptom severity and interference will be measured via the PROMIS® Depression 8-item Short Form, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always."
Measured: Baseline, 10 weeks
Change in symptom severity and interference: illness intrusiveness
Symptom severity and interference will be measured via the Illness Intrusiveness Rating Scale (IIRS). The IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation). Items are rated on a 7-point scale from 1 "not very much" to 7 "very much."
Measured: Baseline, 10 weeks
Change in decisional conflict
Decisional conflict related to menopause management will be assessed using the Decisional Conflict Scale (DCS). The DCS is a 16-item measure assessing decisional conflict. The response ranges are on a 5-point Likert scale ranging from strongly agree to strongly disagree. The minimum score is a 0 and the maximum score is 100, with higher scores indicating more decisional conflict.
Measured: Baseline, 10 weeks
Change in self-efficacy: decision self-efficacy
Self-efficacy will be assessed using the Decision Self-Efficacy Scale, an 11-item measure which assesses self-confidence or belief in one's abilities in decision making, including shared decision making. Responses to each item range from 0 (not at all confident) to 4 (very confident).
Measured: Baseline, 10 weeks
Change in self-efficacy: self-efficacy for managing symptoms
Self-efficacy for managing symptoms will be assessed using an 8-item measure in which participants are asked to rate how confident they are that they can manage common symptoms related to menopause. Participants will be asked to rate their confidence in managing symptoms on a 10-point scale from 1 ("Not at all confident") to 10 ("Very confident").
Measured: Baseline, 10 weeks
Change in patient activation
Patient activation will be assessed using the Patient Activation Measure (PAM). The PAM is a 13-item measure used to assess survivors' knowledge, skills, and confidence that are central to managing their health and health care. Patients are asked to rate their agreement with statements about their health and health care on a 4 point scale from "strongly disagree" to "strongly agree." From these response a total PAM score is calculated on a scale of 0-100, with higher scores indicating higher levels of activation.
Measured: Baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start20 Jan 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MenopauseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rebecca Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982677
- Sponsor's protocol ID
- Pro00117811
- Other IDs
- 1R21CA301298-01
- Status last verified
- May 2026
- First submitted
- 5 May 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Women Experiencing Premature or Early Menopause After Cancer: Development and Pilot Testing of a Novel Intervention
- ClinicalTrials.gov ID
- NCT06982677
- Acronym / sponsor ID
- Pro00117811
- Conditions
- Early Menopause, Cancer, Premature Menopause, Surgical Menopause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: Nurse Navigator InterventionParticipants 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. |
| Education Control | Other | Other: Education ControlParticipants will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse Navigator InterventionThe 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. | Behavioural | Behavioral Intervention |
| Education ControlThe control arm will receive the National Cancer Institute booklet, "Facing Forward: Life After Cancer Treatment," which provides basic strategies for navigating cancer survivorship. | Other | Education Control |
Primary outcome
Feasibility: Enrollment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Change in risk-based knowledge
Time frame: Baseline, 10 weeks
Change in symptom severity and interference: menopause symptoms
Time frame: Baseline, 10 weeks
Change in symptom severity and interference: anxiety
Time frame: Baseline, 10 weeks
Change in symptom severity and interference: depression
Time frame: Baseline, 10 weeks
Change in symptom severity and interference: illness intrusiveness
Time frame: Baseline, 10 weeks
Change in decisional conflict
Time frame: Baseline, 10 weeks
Change in self-efficacy: decision self-efficacy
Time frame: Baseline, 10 weeks
Change in self-efficacy: self-efficacy for managing symptoms
Time frame: Baseline, 10 weeks
Change in patient activation
Time frame: Baseline, 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Shelby, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Navigator Intervention in people with Early Menopause and Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smrithi Divakaran, MPH (919-681-7695, smrithi.divakaran@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Enrollment (time frame: 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.