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

28. maj 2021 opdateret af: Tsai-Wei Huang, Taipei Medical University

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

breast carcinoma in situ women and stage I~III Breast cancer women receiving therapy

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
breast adenocarcinoma
  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.
Adfærdsmæssigt: breast adenocarcinoma receiving chemotherapy
for chemotherapy
Control
  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.
Adfærdsmæssigt: Control-for
hormonal drug treatment
Andre navne:
  • hormonal drug treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trajectory of Symptom distress
Tidsramme: 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.
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;
Trajectory of fatigue
Tidsramme: 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.
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;
Trajectory of distress temperature
Tidsramme: 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.
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;
Trajectory of Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Tidsramme: 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.
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;
Trajectory of PHQ-4: Validated Screening Tool for Anxiety and Depression
Tidsramme: 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.
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;
Trajectory of ISI: Insomnia Severity Index
Tidsramme: 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).
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;

Samarbejdspartnere og efterforskere

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Sponsor

Taipei Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

29. maj 2021

Primær færdiggørelse (Forventet)

31. juli 2024

Studieafslutning (Forventet)

31. juli 2024

Datoer for studieregistrering

Først indsendt

28. maj 2021

Først indsendt, der opfyldte QC-kriterier

28. maj 2021

Først opslået (Faktiske)

3. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • symptom of breast cancer

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