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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2021
Source New York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Expressive Helping
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.

Locations

Country Name City State
United States New York University New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

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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