- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171609
Expressive Writing for Cancer Survivors
August 24, 2020 updated by: Duke University
Expressive Writing for Resilience in Adult Cancer Survivors.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Actual)
14
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
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke Integrative Medicine
-
-
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:
- 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 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: Cancer survivors
Adult survivors of any kind of cancer (except for minor skin cancer) are eligible to participate
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in resilience as measured by the Connor-Davidson Resilience Scale
Time Frame: Baseline, 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-writing survey
Time Frame: 1 day (collected during the 1-day intervention)
|
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.
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1 day (collected during the 1-day intervention)
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Change in quality of life as measured by the Quality of Life Patient/Cancer Survivor Version (QOL-CSV)
Time Frame: Baseline, 6 months
|
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
|
Change in perceived stress as measured by Perceived Stress Scale (PSS-10)
Time Frame: Baseline, 6 months
|
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
|
Change in depression as measured by Center for Epidemiological Studies Depression Scale Revised (CESD-R)
Time Frame: Baseline, 6 months
|
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
|
Qualitative follow-up questionnaire
Time Frame: 6 months
|
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
|
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)
July 19, 2019
Primary Completion (Actual)
May 14, 2020
Study Completion (Actual)
May 14, 2020
Study Registration Dates
First Submitted
November 19, 2019
First Submitted That Met QC Criteria
November 19, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
August 25, 2020
Last Update Submitted That Met QC Criteria
August 24, 2020
Last Verified
November 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Pro00101278
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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