Cancer, Early Menopause, Premature Menopause, Surgical Menopause
Conditions
Brief 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. 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.
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.
Interventions
BEHAVIORALNurse 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.
OTHEREducation 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.
Sponsors
Duke University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: Client Satisfaction Questionnaire | 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. |
| Feasibility: Enrollment | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in risk-based knowledge | Baseline, 10 weeks | 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%). |
| Change in symptom severity and interference: menopause symptoms | Baseline, 10 weeks | 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"). |
| Change in symptom severity and interference: anxiety | Baseline, 10 weeks | 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". |
| Change in symptom severity and interference: depression | Baseline, 10 weeks | 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." |
| Change in patient activation | Baseline, 10 weeks | 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. |
| Change in symptom severity and interference: illness intrusiveness | Baseline, 10 weeks | 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." |
| Change in decisional conflict | Baseline, 10 weeks | 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. |
| Change in self-efficacy: decision self-efficacy | Baseline, 10 weeks | 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). |
| Change in self-efficacy: self-efficacy for managing symptoms | Baseline, 10 weeks | 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"). |
Countries
United States
Contacts
CONTACTSmrithi Divakaran, MPH
CONTACTMichael W Willis
PRINCIPAL_INVESTIGATORRebecca Shelby, PhD
Duke University
Outcome results
None listed