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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04171609
Other study ID # Pro00101278
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 19, 2019
Est. completion date May 14, 2020

Study information

Verified date November 2019
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).


Description:

The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 14, 2020
Est. primary completion date May 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Have ever received a cancer diagnosis

- Have completed cancer treatment (e.g., surgery, radiation, or chemotherapy)

- Are able to speak, read, write, and understand English

- Are cognitively able to provide consent

- Are able to travel to Durham to participate in the 1-day writing intervention

Exclusion Criteria:

-Cancer diagnosis was skin cancer that did not require additional treatment after surgical removal

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Expressive writing
During this daylong expressive writing workshop intervention, the writing instructor coached participants through a series of simple writing exercises. Participation required neither any prior writing experience, nor any desire to become a writer. The practices cultivate natural abilities to express the ideas that define who you are and how you experience your life.

Locations

Country Name City State
United States Duke Integrative Medicine Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in resilience as measured by the Connor-Davidson Resilience Scale This 25-item scale addresses resilience, and has been studied in a variety of populations. Resilience is considered as the capacity to overcome adversity. Baseline, 6 months
Secondary Post-writing survey This five-question survey is used after each writing exercise to measure how respondents reflect on their writing. This survey asks participants to respond to the first four questions using a 10-point Likert-type scale endorsing the degree to which each item reflects their thoughts and feeling about their writing. The fifth question asks for a free-response reflection on how they think and feel about how their writing went. 1 day (collected during the 1-day intervention)
Secondary Change in quality of life as measured by the Quality of Life Patient/Cancer Survivor Version (QOL-CSV) The QOL-CSV is a 41-item ordinal scale measuring quality of life as a cancer patient that originated in use for pain research and was recently adapted for use in long-term cancer survivorship. This survey asks participants to measure their quality of life in terms of the physical, psychological, social, and spiritual dimensions of well-being. Baseline, 6 months
Secondary Change in perceived stress as measured by Perceived Stress Scale (PSS-10) The PSS-10 is a well-known 10-item questionnaire used to evaluate responders' perceptions about their level of stress and their ability to cope with stress over the last month. Results from this questionnaire have demonstrated acceptable levels of validity and reliability. This inventory asks participants to respond using a 10-point Likert-type scale when endorsing the degree to which each item best reflects their thoughts and feelings within the past month. Baseline, 6 months
Secondary Change in depression as measured by Center for Epidemiological Studies Depression Scale Revised (CESD-R) The 20-item CESD-R is one of the most common screening tests that measures depressive feelings and behaviors within the past week. Baseline, 6 months
Secondary Qualitative follow-up questionnaire This qualitative follow-up questionnaire will be administered 6 months after the study intervention to capture participants' reflections on their experience in the study. 6 months
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