The Psychology of Chinese Breast Cancer Patients
21. september 2021 oppdatert av: Ma Fei，MD
Earlier diagnosis of breast cancer in women and the use of systemic adjuvant therapy have increased the likelihood of long term, disease free survival.women
who remain free of breast cancer seem to have levels of functioning and quality of life that are comparable to those of the general female population.It will be assessed the psychology status of women with breast cancer using a clinical interview,
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
It conducts a questionnaire survey of 300 patients. The questionnaires used are: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Quality of Life Scale for Breast Cancer Patients FACT-B, Social Support Rating Scale SSRS. Caregivers should fill in the following scales: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Caregiver Burden Assessment Scale ZBI. Inclusion criteria: 1,female patients with early breast cancer after surgery; 2,no previous mental and psychological abnormalities; 3,Postoperative and prepare to accept adjuvant chemotherapy ; 4,Patient's know her/his illness .
To explore:
- Psychological status and dynamic changes of patients and caregivers during adjuvant chemotherapy after breast cancer surgery in China.
- The influence of psychological status of Chinese breast cancer patients on adverse reactions during adjuvant chemotherapy.
- Gene susceptibility to psychological abnormalities during adjuvant chemotherapy for breast cancer in China.
Studietype
Observasjonsmessig
Registrering (Forventet)
300
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100021
- Cancer Hospital, Chinese Academy of Medical Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Chinese female patients with early breast cancer
Beskrivelse
Inclusion Criteria:
Age：18~75 years; Early stage breast cancer confirmed by histology examination; Patients had undergone surgery for breast cancer; No distant metastasis; Planned to receive recommended postoperative adjuvant chemotherapy; Voluntarily provided written informed consent.
Exclusion Criteria:
Patients already receiving neoadjuvant chemotherapy before surgery; Patients had metastatic disease at diagnosis; Patients had difficulty understanding the questionnaire or communicating in Chinese; Patients had significant psychiatric or other comorbid disease prohibiting participation; Any other researcher believes that it is not appropriate to participate in this test.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychological Distress Thermometer(DT)
Tidsramme: through study completion, an average of 2 year
|
DT uses to identify sources of distress.
It uses a 0 (no distress) to 10 (extreme distress).
|
through study completion, an average of 2 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Depression Scale (HADS)
Tidsramme: through study completion, an average of 2 year
|
HADS was divided into an anxiety subscale and a depression subscale.
Each item is scored from 0 (not at all) to 3 (very much) such that total scores on each sub-scale may range from 0-21.
|
through study completion, an average of 2 year
|
|
Social Support Rating Scale (SSRS)
Tidsramme: through study completion, an average of 2 year
|
Social support was measured by SSRS.
The total score ranges from 12 to 66 points, and higher score indicates higher social support for patients.
|
through study completion, an average of 2 year
|
|
The Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
Tidsramme: through study completion, an average of 2 year
|
The FACT-B is a 37-item instrument evaluating QoL issues.
The domain scores for physical, social/family and functional well-being range from 0 to 28, the emotional domain scores from 0 to 24 points, the breast cancer- specific subscale domain scores from 0 to 40.
|
through study completion, an average of 2 year
|
|
Zarit Caregiver Burden Interview (ZBI)
Tidsramme: through study completion, an average of 2 year
|
ZBI Is developed as 29-item self-report scale aimed to assess the subjective burden experienced by an caregiver.
|
through study completion, an average of 2 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Gregorowitsch ML, van den Bongard HJGD, Young-Afat DA, Pignol JP, van Gils CH, May AM, Verkooijen HM. Severe depression more common in patients with ductal carcinoma in situ than early-stage invasive breast cancer patients. Breast Cancer Res Treat. 2018 Jan;167(1):205-213. doi: 10.1007/s10549-017-4495-y. Epub 2017 Sep 11.
- Ng CG, Mohamed S, Kaur K, Sulaiman AH, Zainal NZ, Taib NA; MyBCC Study group. Perceived distress and its association with depression and anxiety in breast cancer patients. PLoS One. 2017 Mar 15;12(3):e0172975. doi: 10.1371/journal.pone.0172975. eCollection 2017.
- de Souza BF, de Moraes JA, Inocenti A, dos Santos MA, Silva AE, Miasso AI. Women with breast cancer taking chemotherapy: depression symptoms and treatment adherence. Rev Lat Am Enfermagem. 2014 Oct;22(5):866-73. doi: 10.1590/0104-1169.3564.2491.
- Andersen BL, Yang HC, Farrar WB, Golden-Kreutz DM, Emery CF, Thornton LM, Young DC, Carson WE 3rd. Psychologic intervention improves survival for breast cancer patients: a randomized clinical trial. Cancer. 2008 Dec 15;113(12):3450-8. doi: 10.1002/cncr.23969.
- Antoni MH, Jacobs JM, Bouchard LC, Lechner SC, Jutagir DR, Gudenkauf LM, Blomberg BB, Gluck S, Carver CS. Post-surgical depressive symptoms and long-term survival in non-metastatic breast cancer patients at 11-year follow-up. Gen Hosp Psychiatry. 2017 Jan-Feb;44:16-21. doi: 10.1016/j.genhosppsych.2016.10.002. Epub 2016 Oct 22.
- Berhili S, Kadiri S, Bouziane A, Aissa A, Marnouche E, Ogandaga E, Echchikhi Y, Touil A, Loughlimi H, Lahdiri I, El Majjaoui S, El Kacemi H, Kebdani T, Benjaafar N. Associated factors with psychological distress in Moroccan breast cancer patients: A cross-sectional study. Breast. 2017 Feb;31:26-33. doi: 10.1016/j.breast.2016.10.015. Epub 2016 Oct 28.
- Giese-Davis J, Waller A, Carlson LE, Groff S, Zhong L, Neri E, Bachor SM, Adamyk-Simpson J, Rancourt KM, Dunlop B, Bultz BD. Screening for distress, the 6th vital sign: common problems in cancer outpatients over one year in usual care: associations with marital status, sex, and age. BMC Cancer. 2012 Oct 2;12:441. doi: 10.1186/1471-2407-12-441.
- Gold M, Dunn LB, Phoenix B, Paul SM, Hamolsky D, Levine JD, Miaskowski C. Co-occurrence of anxiety and depressive symptoms following breast cancer surgery and its impact on quality of life. Eur J Oncol Nurs. 2016 Feb;20:97-105. doi: 10.1016/j.ejon.2015.06.003. Epub 2015 Jul 15.
- Guo X, Xu J, Ying E, Yu Z, Sun T. Correlation between hormone receptor status and depressive symptoms in patients with metastatic breast cancer. Oncotarget. 2017 Feb 2;8(31):50774-50781. doi: 10.18632/oncotarget.15037. eCollection 2017 Aug 1.
- Kaminska M, Kubiatowski T, Ciszewski T, Czarnocki KJ, Makara-Studzinska M, Bojar I, Staroslawska E. Evaluation of symptoms of anxiety and depression in women with breast cancer after breast amputation or conservation treated with adjuvant chemotherapy. Ann Agric Environ Med. 2015;22(1):185-9. doi: 10.5604/12321966.1141392.
- Kim SY, Kim SW, Shin IS, Park MH, Yoon JH, Yoon JS, Kim JM. Changes in depression status during the year after breast cancer surgery and impact on quality of life and functioning. Gen Hosp Psychiatry. 2018 Jan-Feb;50:33-37. doi: 10.1016/j.genhosppsych.2017.09.009. Epub 2017 Sep 29.
- Kim YH, Choi KS, Han K, Kim HW. A psychological intervention programme for patients with breast cancer under chemotherapy and at a high risk of depression: A randomised clinical trial. J Clin Nurs. 2018 Feb;27(3-4):572-581. doi: 10.1111/jocn.13910. Epub 2017 Jul 6.
- So WK, Marsh G, Ling WM, Leung FY, Lo JC, Yeung M, Li GK. Anxiety, depression and quality of life among Chinese breast cancer patients during adjuvant therapy. Eur J Oncol Nurs. 2010 Feb;14(1):17-22. doi: 10.1016/j.ejon.2009.07.005. Epub 2009 Sep 5.
- Zhang J, Zhou Y, Feng Z, Xu Y, Zeng G. Longitudinal Trends in Anxiety, Depression, and Quality of Life During Different Intermittent Periods of Adjuvant Breast Cancer Chemotherapy. Cancer Nurs. 2018 Jan/Feb;41(1):62-68. doi: 10.1097/NCC.0000000000000451.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. april 2019
Primær fullføring (Faktiske)
31. desember 2020
Studiet fullført (Forventet)
31. desember 2021
Datoer for studieregistrering
Først innsendt
22. oktober 2018
Først innsendt som oppfylte QC-kriteriene
21. september 2021
Først lagt ut (Faktiske)
24. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCC1867
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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