Symptom Monitoring and Menopausal Symptoms

Study Overview
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Brief Summary
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A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women. One hundred menopausal women were randomised into either a Monitoring-intervention or Control group. A mixed between/ within design was employed, with group membership (i.e., Monitoring-intervention or Control) as the between-subjects component, and time (i.e., baseline and 2-weeks follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions. Secondary outcomes included help-seeking, communication, medical decision-making, health awareness, self-efficacy, and health anxiety.

Official Title
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Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial

Conditions
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Menopause

Intervention / Treatment
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* Behavioral: Symptom Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Women Aged 18+ Reporting at least 2 menopausal hot flushes per day Self-reported peri- or post-menopausal status. Exclusion criteria: Male Under age 18 Reported fewer than 2 hot flushes per day Does not self-report peri- or post-menopausal status.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptom Monitoring Intervention<br>This group reported their symptoms every day for 14 days. | Behavioral: Symptom Monitoring<br>* Reporting symptoms each day via a symptom questionnaire<br>|
| No Intervention: Control<br>This group did not monitor their symptoms every day for the 14 day period, however they did report their symptoms at the beginning and end of the 14 day period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopausal symptom changes via the Daily Record Keeping (DRK) form | Changes in menopausal symptom scores after 2-weeks of symptom monitoring, where reductions in symptoms would suggest a beneficial outcomes. | at baseline and after 2 weeks of symptom monitoring | 
| Emotional outcomes via the Daily Record Keeping (DRK) form | Changes in emotion scores after 2-weeks of symptom monitoring. The DRK assesses emotional outcomes via specific emotion subscales including Negative Emotions, Positive affect, Anxiety, Depression, Loneliness. Reductions in Negative Emotions, Anxiety, Loneliness, Depression after 2-weeks would suggest benefical effects, as would increases in Positive Affect. | at baseline and after 2 weeks of symptom monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Help seeking intentions | Changes in Help Seeking Intention scores as assessed via the General Help Seeking Questionnaire (GHSQ). Increases in GHSQ scores at 2-weeks would indicate benefical effects on help seeking behaviour. | at baseline and after 2 weeks of symptom monitoring | 
| General Self Efficacy | Changes in General Self Efficacy scores as assessed via the General Self Efficacy (GSE) scale. Increases in GSE scores at 2-weeks would indicate beneficial effects on self efficacy. | at baseline and after 2 weeks of symptom monitoring | 
| Decision making efficacy | Changes in Decision making efficacy scores as assessed via the Decision Self Efficacy (DSE) scale. Increases in DSE scores after 2-weeks would suggest benefical effects on medical decision making. | at baseline after 2 weeks of symptom monitoring | 
| Health communication | Changes in Health communication scores as assessed via the Willingness to Communicate about Health (WTCH) questionnaire. Increases in WTCH scores after 2-weeks would suggest benefical effects on health communication. | at baseline after 2 weeks of symptom monitoring | 
| Health Anxiety | Changes in Health Anxiety scores as assessed via the Health Orientation Scale (HOS). Reductions in Health Anxiety after 2-weeks would suggest beneficial effects. | at baseline and after 2 weeks of symptom monitoring | 
| Health Consciousness | Changes in Health Consciousness scores as assessed via the HOS. Reductions in Health Consciousness scores after 2-weeks would suggest beneficial effects. | at baseline and after 2 weeks of symptom monitoring | 
| Coping preference | Monitoring/ Blunting Coping preference assessed via the Miller's Behavioural Style Scale (MBSS). The MBSS score can be used in analyses as a continuous variable, with individuals displaying more or less monitoring coping characteristics. Scores range from 0 (no monitoring characteristics) to 72 (high monitoring characteristics). | Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes | 
| Trait neuroticism | Trait neuroticism was assessed via the IPIP-NEO 10-item neuroticism subscale. This scale ranges from 10 (low trait neuroticism) to 50 (high trait neuroticism). | Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Hot flushes, Women's Health, Symptom Monitoring