Cancer Clinical Trial
Official title:
Feasibility of Expressive Helping for Chinese-Speaking Cancer Patients and Survivors
| NCT number | NCT03945734 |
| Other study ID # | 19-0612 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 20, 2019 |
| Est. completion date | December 30, 2020 |
| Verified date | March 2021 |
| Source | New York University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 30, 2020 |
| Est. primary completion date | December 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | New York University | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| New York University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants screened | The number of participants screened for eligibility will be counted. | through study completion, an average of 1 year | |
| Primary | Compliance rate | Compliance rate is calculated by dividing the number of writing/voice-recording sessions finished by the number of sessions assigned. | through study completion, an average of 1 year | |
| Primary | Retention rate | Retention rate is calculated by dividing the number of participants who began the study by the number of participants who finished the entire study. | through study completion, an average of 1 year | |
| Primary | Meaningfulness of the study | We will ask participants open-ended questions about whether they felt participating in this study was meaningful to them. | This will be assessed approximately four weeks after the baseline | |
| Secondary | Change in quality of life as assessed by the Functional Assessment of Cancer Therapy Scale (FACT). | 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). | Baseline; 1-month follow-up; 3-month follow-up | |
| Secondary | Change in depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). | The CES-D (Radloff, 1977) is a 20-item measure of depressive symptoms. | Baseline; 1-month follow-up; 3-month follow-up |
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