Cancer SurvivorsNCT04171609
Expressive Writing for Cancer Survivors
A study testing Expressive writing in people with Cancer Survivors, run by Duke University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2019to 14 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Cancer diagnosis was skin cancer that did not require additional treatment after surgical removal
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Integrative Medicine
Durham, North Carolina, 27705
About this study
Official title: 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).
Read the 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).
- Conditions
- Cancer Survivors
- Being tested
- Expressive writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer survivors | Experimental | Adult survivors of any kind of cancer (except for minor skin cancer) are eligible to participate Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Secondary outcomes (5)
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.
Measured: 1 day (collected during the 1-day intervention)
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.
Measured: Baseline, 6 months
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.
Measured: Baseline, 6 months
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.
Measured: Baseline, 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start19 Jul 2019
- Primary completion14 May 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Glass, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171609
- Sponsor's protocol ID
- Pro00101278
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing for Resilience in Adult Cancer Survivors.
- ClinicalTrials.gov ID
- NCT04171609
- Acronym / sponsor ID
- Pro00101278
- Conditions
- Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer survivors | Experimental | Behavioral: Expressive writingAdult survivors of any kind of cancer (except for minor skin cancer) are eligible to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -Cancer diagnosis was skin cancer that did not require additional treatment after surgical removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingDuring 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. | Behavioural | Cancer survivors |
Primary outcome
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.
5 secondary outcomes
Post-writing survey
Time frame: 1 day (collected during the 1-day intervention)
Change in quality of life as measured by the Quality of Life Patient/Cancer Survivor Version (QOL-CSV)
Time frame: Baseline, 6 months
Change in perceived stress as measured by Perceived Stress Scale (PSS-10)
Time frame: Baseline, 6 months
Change in depression as measured by Center for Epidemiological Studies Depression Scale Revised (CESD-R)
Time frame: Baseline, 6 months
Qualitative follow-up questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Glass, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in people with Cancer Survivors, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resilience as measured by the Connor-Davidson Resilience Scale (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.