- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03945734
Expressive Helping for Chinese-Speaking Cancer Patients and Survivors
October 31, 2022 updated by: New York University
Feasibility of Expressive Helping for Chinese-Speaking Cancer Patients and Survivors
This study examines the feasibility, cultural-sensitivity, and health effects of the expressive helping intervention by conducting a single-arm trial with Chinese-speaking cancer patients and survivors.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study examines whether expressive helping is feasible and culturally-sensitive for Chinese American cancer patients and survivors.
For 20 minutes each week over four weeks, participants choose to write or voice-record their thoughts about cancer by following specific prompts designed to help them process their cancer experiences.
During the last week of this reflection exercise, participants write or voice-record an anonymous letter to another Chinese cancer patient by sharing their cancer experience and providing advice and encouragement.
Health outcomes are assessed at baseline, 1-month, and 3-month follow-ups.
A subset of the participants will be invited to share their experiences with the study through qualitative interviews after the last writing/voice-recording session.
This research study provides an opportunity for Chinese American cancer patients and survivors to express their feelings without the fear of burdening others, and give them an opportunity to help others by sharing their cancer experiences.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10003
- New York University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of cancer (any type)
- Of Chinese descent
- Over the age of 18
- Can speaking and read Mandarin Chinese
Exclusion Criteria:
- Completed primary cancer treatment more than five years ago
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Expressive Helping
Participants complete four 20-minute writing/voice-recording sessions spaced one week apart.
During the first week, the instructions will explain that cancer patients and survivors benefit from learning about other cancer survivors' experiences.
They are told that the first three weeks of writing/voice-recording (writing/talking about their stress and coping at Week 1, deepest emotions about cancer at Week 2, self-affirmation and benefit finding at Week 3) are exercises designed to help them think about their cancer experiences and to prepare them to write/record the narrative they would share on Week 4.
During Week 4, they are asked to write/record a narrative as if they are speaking to another Chinese person with cancer, adding advice and encouragements, and reminded that their writing/recording would be shared with other Chinese American cancer patients and survivors.
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Expressive helping harnesses the benefits of helping others (e.g., support giving) through writing or voice-recording.
Expressive helping integrates two distinct areas of research showing that writing or speaking about ones' negative experiences and engaging in support giving behaviors can improve psychological well-being.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants screened
Time Frame: through study completion, an average of 1 year
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The number of participants screened for eligibility will be counted.
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through study completion, an average of 1 year
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Compliance rate
Time Frame: through study completion, an average of 1 year
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Compliance rate is calculated by dividing the number of writing/voice-recording sessions finished by the number of sessions assigned.
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through study completion, an average of 1 year
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Retention rate
Time Frame: through study completion, an average of 1 year
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Retention rate is calculated by dividing the number of participants who began the study by the number of participants who finished the entire study.
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through study completion, an average of 1 year
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Meaningfulness of the study
Time Frame: This will be assessed approximately four weeks after the baseline
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We will ask participants open-ended questions about whether they felt participating in this study was meaningful to them.
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This will be assessed approximately four weeks after the baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life as assessed by the Functional Assessment of Cancer Therapy Scale (FACT).
Time Frame: Baseline; 1-month follow-up; 3-month follow-up
|
The Functional Assessment of Cancer Therapy Scale (FACT) is a 27-item measure of health-related quality of life (Cella & Tulsky,1993).
This scale assesses contains four different subscales, including physical well-being (7 items), social well-being (7 items), emotional well-being (6 items), and functional well-being (7 items).
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Baseline; 1-month follow-up; 3-month follow-up
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Change in depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D).
Time Frame: Baseline; 1-month follow-up; 3-month follow-up
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The CES-D (Radloff, 1977) is a 20-item measure of depressive symptoms.
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Baseline; 1-month follow-up; 3-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2019
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
May 7, 2019
First Submitted That Met QC Criteria
May 8, 2019
First Posted (Actual)
May 10, 2019
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 19-0612
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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