Trajectory Analysis of Symptom Distress and Cancer-related Fatigue After Adjuvant Chemotherapy in Breast Cancer Female

• Conditions: Symptom Distress During Breast Cancer Treatment
• Interventions: Behavioral: Control-for; Behavioral: breast adenocarcinoma receiving chemotherapy

• Registration Number: NCT04911699
• Lead Sponsor: Taipei Medical University

Brief Summary

When receiving adjuvant chemotherapy, a variety of symptoms will appear and it is very painful. These symptoms occur at the same time and are related to each other. The symptom distress may affect the patient's compliance with adjuvant chemotherapy and whether the adjuvant chemotherapy can be completed on schedule. Among the symptoms of trouble, cancer-related fatigue is the most common, and the incidence can be as high as 99%. In this study, I want to track the population of breast cancer patients receiving adjuvant chemotherapy, and women in the control group who receive only anti-hormonal breast cancer or carcinoma in situ. During the treatment period, at different time points, it also collects subjective symptom distress changes and changes. The study aimed cancer-related exhaustion is measured to gain a deeper understanding of the effects of symptom troubles suffered by patients during treatment. We also hoped that in the future, it can be provided to colleagues in clinical work and can be given to breast cancer patients receiving adjuvant chemotherapy and increased holistic care quality.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Last Update Submitted: 2021-05-28
• Study Start: 2021-05-29
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. The surgical pathological tissue report confirms that the diagnosis is zero stage breast carcinoma in situ women and stage I~III Breast cancer women.
2. Those who are admitted to the hospital for the first time adjuvant chemotherapy or hormonal therapy.
3. Age (inclusive) over 20 years old

Exclusion Criteria

1. Women with breast cancer who are unconscious or unable to express.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Control-for	1. The surgical pathological tissue report establishes women diagnosed as stage 0 to stage III breast cancer 2. Those who are admitted to the hospital to receive anti-hormonal drug treatment. 3. Age (inclusive) over 20 years old.
breast adenocarcinoma	breast adenocarcinoma receiving chemotherapy	1. The surgical pathological tissue report confirms the diagnosis of breast adenocarcinoma women with stage I\~III 2. Those who are admitted to the hospital and receive adjuvant chemotherapy for the first time. 3. Age (inclusive) over 20 years old.

Primary Outcome Measures

Name	Time	Method
Trajectory of Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)	T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;	FACT-B;multidimensional questionnaire with 37 items that build 5 dimensions (subscales) when using a 5-point Likert scale. (from 0, not at all through 4, very much) that constitute 5 dimensions.
Trajectory of ISI: Insomnia Severity Index	T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;	(ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.11,24 The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Trajectory of Symptom distress	T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;	Edmonton Symptom Assessment Scale, ESAS; including nine symptoms, one symptom range from 0-10, total score 0-90.
Trajectory of PHQ-4: Validated Screening Tool for Anxiety and Depression	T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;	PHQ-4;PHQ-4 Scoring: Total score ranges from 0 to 12, with categories of psychological distress as follows: None: 0-2; Mild: 3-5; Moderate: 6-8; Severe: 9-12; Anxiety subscale = sum of items 1 and 2 (score range: 0 to 6) Depression subscale = sum of items 3 and 4 (score range: 0 to 6) On each subscale, a score of 3 or greater is considered positive for screening purposes.
Trajectory of fatigue	T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;	Brife fatigue inventory, BFI; including nine items, total score 0-10.
Trajectory of distress temperature	T0 to T6, T0 pre chemotherapy; T1, chemotherapy 1 month; T2, chemotherapy 2 month; T3, chemotherapy 3 month;T4, chemotherapy 4 month;T5, chemotherapy 5 month;T6, chemotherapy 6 month;	Distress Thermometer, DT; range from 0-10.