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Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors

2 septembre 2019 mis à jour par: Qian Lu, University of Houston

Reducing Psychological Burdens Among Chinese Breast Cancer Survivors

This study is a randomized controlled trial (RCT) with the aim of determining the cultural sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese breast cancer survivors.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The study examines the potential health benefits (i.e., physical health, psychological health, and quality of life) of this expressive writing intervention for Chinese-speaking breast cancer survivors. The study also explores the mechanism through which expressive writing confers health benefits and investigates who will benefit most from the expressive writing intervention. Chinese-speaking breast cancer survivors who have completed primary treatment will be randomly assigned to a control writing condition, a self-regulation condition, or a enhanced self-regulation writing condition. Health outcomes are assessed at baseline, and 1, 3, and 6 months follow-ups. Mixed qualitative-quantitative mixed methods are used to explore the effect of the intervention on health outcomes and explore the mechanisms that explain the benefits of this intervention.

Type d'étude

Interventionnel

Inscription (Réel)

136

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 91776
        • Herald Cancer Association
    • Texas
      • Houston, Texas, États-Unis, 77204
        • University of Houston

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Condition de contrôle
Les participants du groupe témoin ont été invités à écrire pendant trois semaines sur des faits concernant leur cancer et son traitement pendant trois séances.
Expérimental: 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.
Comportemental: Condition d'autorégulation
Expérimental: 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.
Comportemental: Enhanced self-Regulation Condition

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in quality of life score as assessed by the Functional Assessment of Cancer Therapy Scale (FACT)
Délai: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
Délai: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

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.
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)
Délai: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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.
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in depressive symptoms as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
Délai: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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.
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in anxiety as assessed by Brief Symptom Inventory (BSI)-anxiety dimension
Délai: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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.
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
Change in physical symptoms as assessed by the Physical Symptoms Checklist
Délai: Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.
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.
Baseline, 1 month, 3 months, and 6 months follow-ups after the intervention.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Houston

Collaborateurs

American Cancer Society, Inc.
Herald Cancer Association

Les enquêteurs

  • Chercheur principal: Qian Lu, Ph.D., MD, University of Houston

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2012

Achèvement primaire (Réel)

1 mars 2016

Achèvement de l'étude (Réel)

1 mars 2016

Dates d'inscription aux études

Première soumission

21 octobre 2016

Première soumission répondant aux critères de contrôle qualité

25 octobre 2016

Première publication (Estimation)

27 octobre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 septembre 2019

Dernière vérification

1 septembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MRSGT-10-011-01-CPPB

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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