Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors
2019년 9월 2일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
136
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Los Angeles, California, 미국, 91776
- Herald Cancer Association
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Texas
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Houston, Texas, 미국, 77204
- University of Houston
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어 조건
통제 그룹의 참가자들은 3주 동안 그들의 암과 치료에 관한 사실에 대해 3회에 걸쳐 글을 쓰도록 요청받았습니다.
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in quality of life score as assessed by the Functional Assessment of Cancer Therapy Scale (FACT)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in posttraumatic stress disorder (PTSD), as assessed by the PTSD Symptom Scale - Self Report version (PSS-SR)
기간: 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)
기간: 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).
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Qian Lu, Ph.D., MD, University of Houston
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 6월 1일
기본 완료 (실제)
2016년 3월 1일
연구 완료 (실제)
2016년 3월 1일
연구 등록 날짜
최초 제출
2016년 10월 21일
QC 기준을 충족하는 최초 제출
2016년 10월 25일
처음 게시됨 (추정)
2016년 10월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 2일
마지막으로 확인됨
2019년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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