Clinical trial NCT04911699: Trajectory Analysis of Symptom Distress and Cancer-related Fatigue After Adjuvant Chemotherapy in Breast Cancer Female
Official title: Trajectory Analysis of Symptom Distress and Cancer-related Fatigue After Adjuvant Chemotherapy in Breast Cancer Female: an Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Symptom Distress During Breast Cancer Treatment
Keywords: Breast cancer
cancer related fatigue
symptom distress
insomnia
chemotherapy
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breast carcinoma in situ women and stage I\~III Breast cancer women receiving therapy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Trajectory of Symptom distress
timeFrame: 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;
measure: Trajectory of fatigue
timeFrame: 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;
measure: Trajectory of distress temperature
timeFrame: 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;
measure: Trajectory of Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: 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;
measure: Trajectory of PHQ-4: Validated Screening Tool for Anxiety and Depression
timeFrame: 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;
measure: Trajectory of ISI: Insomnia Severity Index
timeFrame: 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;
Secondary outcomes:
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