유방암 생존자의 Suvorexant

실험적: 수면 위생에 대한 정보가 포함된 Suvorexant

이 그룹에 무작위로 배정된 참가자는 매일 10mg의 수보렉산트를 투여받게 되며 7일차 이후에는 용량을 20mg으로 증량하게 됩니다. 약물은 경구 약물로 투여됩니다. 총 기간은 28일입니다.

의약품: 수보렉산트 정제

Suvorexant는 초기에 28일 동안 10-20 mg을 투여합니다.

위약 비교기: Placebo with information on sleep hygiene

Participants randomized to this arm will receive placebo control daily with a switch to an alternate placebo control vial after 7 days, consistent with intervention arms. Medication will be administered as an oral medication. Total duration of 28 days.

다른: 위약 대조

28일 동안 일치하는 위약 대조

Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)

The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study.

Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale

Vasomotor symptoms were assessed using the Hot Flash Related Daily Interference Scale. This validated instrument measures the extent to which hot flashes interfere with daily activities and quality of life. Scores range from 0 to 100, with higher scores indicating greater interference due to vasomotor symptoms. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Quality of Life Evaluated Using the SF-36

Health-related quality of life was assessed using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). We have reported the average domain score for the general health domain. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Quality of Life Evaluated Using the Cancer Problems in Living Scale (CPIL)

Problems related to living with cancer were assessed using the Cancer Problems of Living (CPIL) Scale. The CPIL consists of a multi-item list of cancer-related problems across practical, emotional, and social domains. Participants rate each problem based on perceived severity, with higher ratings indicating greater problem severity. Each item is scored on a scale of 0-2 with the composite score reported. Score range from 0 to 58. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)

Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI asks participants to rate current pain, average pain, least pain, and worst pain on numeric rating scales ranging from 0 to 10, with higher scores indicating greater pain severity. A total pain severity score can be calculated by averaging these items. Score range is from 0 to 10. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Number of Participants Reported as Adherent Using the Simplified Medication Adherence Questionnaire (SMAQ)

Medication adherence was assessed using the Simplified Medication Adherence Questionnaire (SMAQ). The SMAQ is a brief, participant-reported questionnaire composed of six multiple-choice questions evaluating medication-taking behavior. Non-adherence is indicated by any positive response suggesting missed doses or by reporting more than two missed doses during the preceding week. The outcome reported was the number of participants who were adherent based on this evaluation. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Vasomotor Symptoms Assessed Using the Hot Flash Related Daily Interference Scale

Vasomotor symptoms were assessed using the Hot Flash Related Daily Interference Scale. This validated instrument measures the extent to which hot flashes interfere with daily activities and quality of life. Scores range from 0 to 100, with higher scores indicating greater interference due to vasomotor symptoms. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Participant Reported Insomnia Symptoms Evaluated Using the Insomnia Severity Index (ISI)

The Insomnia Severity Index (ISI) score was evaluated at baseline, 2 weeks, and 4 weeks. The ISI is scored on a scale of 0-28 based on responses to 7 questions, with higher values indicating more severe symptoms of sleep disturbance. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.

Pain Evaluation Evaluated Using the Brief Pain Inventory (BPI)

Pain severity was assessed using the Brief Pain Inventory (BPI). The BPI asks participants to rate current pain, average pain, least pain, and worst pain on numeric rating scales ranging from 0 to 10, with higher scores indicating greater pain severity. A total pain severity score can be calculated by averaging these items. Score range is from 0 to 10. Five participants completed the study. Due to early study termination for insufficient accrual, the planned statistical analyses were not performed.