- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02946619
Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors
Reducing Psychological Burdens Among Chinese Breast Cancer Survivors
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 91776
- Herald Cancer Association
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Texas
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Houston, Texas, Forente stater, 77204
- University of Houston
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
1) having a breast cancer diagnosis; 2) completing breast cancer surgery within five years; and 3) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Kontrolltilstand
Deltakerne i kontrollgruppen ble bedt om å skrive i tre uker om fakta om kreften deres og behandlingen av den i tre økter.
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Eksperimentell: Self-regulation condition
For the self-regulation condition, each weekly writing assignment covers a different task.
During session one, participants will be asked to write about their deepest feelings and thoughts regarding their experience with breast cancer as well as its impact on their lives; in session two, participants will be asked to write about their coping strategies to deal with stressors associated with the cancer diagnosis and treatment, as well as future plans for coping with cancer-related stressors; and in session three, participants will be asked to write about positive thoughts and feelings regarding their experience with breast cancer.
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Eksperimentell: Enhanced self-regulation condition
For the enhanced self-regulation condition, each weekly writing assignment covers a different task.
During session one, participants will be asked to write about their coping strategies to deal with stressors associated with the cancer diagnosis and treatment, as well as future plans for coping with cancer-related stressors; during session two, participants will be asked to write about their deepest feelings and thoughts regarding their experience with breast cancer as well as its impact on their lives; and in session three, participants will be asked to write about positive thoughts and feelings regarding their experience with breast cancer.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in quality of life score as assessed by the Functional Assessment of Cancer Therapy Scale (FACT)
Tidsramme: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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The Functional Assessment of Cancer Therapy Scale (FACT) is a 27-item measure of health-related quality of life (Cella & Tulsky,1993), which assesses perceived life quality in four different facets, including physical well-being (7 items,score range 0 - 28), social well-being (7 items, score range 0 - 28), emotional well-being (6 items, score range 0-24), and functional well-being (7 items, score range 0-28). A higher subscale score indicates better functioning in the corresponding domain. Total score is computed by summing up the scores of the four subscales. Total score ranges from 0 to 108. A higher score indicates better quality of life. |
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
Tidsramme: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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The scale contains 17 items reflecting the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition -Text Revision (DSM-IV-TR) symptoms of post-traumatic stress disorder (Foa, Riggs, Dancu, & Rothbaum, 1993). Score can be reported in terms of total score or the score of the three subscales (Re-experiencing, Avoidance and Hyperarousal). The score ranges for the three sub-scales are: Re-experiencing symptoms (5 items, 0-15), Avoidance symptoms (7 items, 0 -21) and Hyperarousal symptoms (5 items, 0-15). Each subscale score is computed by summing up the scores of the corresponding items. For each subscale, a higher score indicates more severe symptoms. The total score is computed by summing up the scores of the three subscales. The total score ranges from 0 to 51. A higher score indicated more severe PTSD symptoms. |
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
Tidsramme: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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The scale contains 13 items.
Total score is computed by summing up the scores of all the 13 items.
The total score ranges from 0 to 52.
A higher score indicates more severe fatigue symptoms.
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
Tidsramme: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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The scale contains 10 items.
Total score is computed by summing up the scores of all the 10 items.
Total score ranges from 0 to 30.
A higher scores indicates more severe depression symptoms.
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension
Tidsramme: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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The scale contains 6 items.
Total score is computed by summing up the scores of all the 6 items.
Total score ranges from 0 - 24.
A higher score indicates more severe anxiety symptoms.
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Change in physical symptoms as assessed by the Physical Symptoms Checklist
Tidsramme: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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The scale contains 10 items.
Total score is computed by summing up the scores of all the 10 items.
Total score ranges from 0 - 300.
A higher score indicates more severe physical symptoms.
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Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Qian Lu, Ph.D., MD, University of Houston
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Chu Q, Wu IHC, Tang M, Tsoh J, Lu Q. Temporal relationship of posttraumatic stress disorder symptom clusters during and after an expressive writing intervention for Chinese American breast cancer survivors. J Psychosom Res. 2020 Aug;135:110142. doi: 10.1016/j.jpsychores.2020.110142. Epub 2020 May 16.
- Chu Q, Wu IHC, Lu Q. Expressive writing intervention for posttraumatic stress disorder among Chinese American breast cancer survivors: the moderating role of social constraints. Qual Life Res. 2020 Apr;29(4):891-899. doi: 10.1007/s11136-019-02385-5. Epub 2020 Jan 3.
- Lu Q, Gallagher MW, Loh A, Young L. Expressive Writing Intervention Improves Quality of Life Among Chinese-American Breast Cancer Survivors: A Randomized Controlled Trial. Ann Behav Med. 2018 Oct 22;52(11):952-962. doi: 10.1093/abm/kax067.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MRSGT-10-011-01-CPPB
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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