Cancer Survivors Clinical Trial
Official title:
Expressive Writing for Resilience in Adult Cancer Survivors.
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 |
Verified date | November 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke Integrative Medicine | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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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