Health Benefits of Expressive Writing: Study One

NCT ID: NCT03546673

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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 an emotional disclosure 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.

Conditions

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Breast Cancer Breast Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control Condition

Participants in the control group were asked to write for three weeks about facts regarding their cancer and its treatment for three sessions.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Self-Regulation Condition

Intervention Type BEHAVIORAL

Emotional Disclosure condition

For the emotional disclosure condition, participants were asked to write about their deepest thoughts and feelings about their cancer experience for three weeks.

Group Type EXPERIMENTAL

Emotional Disclosure Condition

Intervention Type BEHAVIORAL

Interventions

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Self-Regulation Condition

Intervention Type BEHAVIORAL

Emotional Disclosure Condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 1\) having a breast cancer diagnosis
* 2\) completing primary medical treatment within four years
* 3\) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Herald Cancer Association

OTHER

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Qian Lu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qian Lu, Ph.D., MD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

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Herald Cancer Association

Los Angeles, California, United States

Site Status

University of Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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Chu Q, Wong CCY, Lu Q. Acculturation Moderates the Effects of Expressive Writing on Post-Traumatic Stress Symptoms Among Chinese American Breast Cancer Survivors. Int J Behav Med. 2019 Apr;26(2):185-194. doi: 10.1007/s12529-019-09769-4.

Reference Type DERIVED
PMID: 30656609 (View on PubMed)

Other Identifiers

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09021-02

Identifier Type: -

Identifier Source: org_study_id

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