Cancer SurvivorsNCT01888523
Stress Management for Cancer Survivors
A study testing Expressive writing and Everyday experiences writing in people with Cancer Survivors, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Determine the efficacy of a brief and inexpensive psychosocial intervention, (called expressive writing) in improving health outcomes for cancer survivors. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Expressive writing and Everyday experiences writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have completed their cancer radiation treatment (intent to cure),
- are cancer free, i.e. do not have currently have a diagnosis of primary/secondary cancer or any recurrence/relapse of cancer,
- are in the re-entry phase of cancer survivorship, i.e. 2-12 months post-treatment completion,
- have access to a computer and internet in a private setting, e.g. at home,
- are fluent in English,
- are able to provide informed consent.
Who cannot join
- patients scheduled to undergo any type of cancer treatment (intent to cure/palliative) in the future (e.g. surgery after completing radiation),
- patients on any kind of corticosteroid medication (e.g. long-term prednisone therapy),
- patients having any condition that affects function of the adrenal glands (e.g. adrenal hyperplasia),
- patients with limited ability to produce saliva, e.g. patients that received radiation (or surgery) on the face region or on salivary glands; or patient's suffering from dry mouth (e.g. Sjögren's syndrome),
- patient's suffering from inflammation of the oral cavity (e.g. gingivitis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Stress Management for Cancer Survivors Using a Technologically Adapted Psychosocial Intervention: A Randomized Trial Determining the Effect of Expressive Writing on Psychoneuroimmunology Based Outcomes
Determine the efficacy of a brief and inexpensive psychosocial intervention, (called expressive writing) in improving health outcomes for cancer survivors.
Read the detailed description
This study aims to evaluate a computer-based stress-management therapy called expressive writing. This involves logging in to an online survey and writing in the survey about your thoughts and feelings about your cancer or to type in your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.
- Conditions
- Cancer Survivors
- Being tested
- Expressive writing, Everyday experiences writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
log in to an online survey and writing in the survey about your thoughts and feelings about your cancer. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.
Everyday experiences writingBehavioural
log in to an online survey and writing in the survey about your thoughts and feelings about your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.
| Study group | Role | What they receive |
|---|---|---|
| Everyday experiences writing | Experimental | Involves logging in to an online survey and writing in the survey about your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples. Receives: Behavioral: Everyday experiences writing |
| Expressive writing | Experimental | Involves logging in to an online survey and writing in the survey about your thoughts and feelings about your cancer. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples. Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary cortisol levels
Participants will be asked to give their saliva samples through chewable swabs 3 times per day on every day of data collection, i.e. once at baseline, which is 24 hours before the intervention, and twice after the intervention, specifically, 24 hours and 6 weeks post-intervention. Participants will be requested to chew on their swabs and spit into their containers at the following times: 1) immediately after waking up, 2) within 30 min after waking, and 3) immediately before going to sleep.
Measured: Up to 6 weeks
Secondary outcomes (2)
salivary α-amylase and C-Reactive Protein (CRP)
Participants will be asked to give their saliva samples through chewable swabs 3 times per day on every day of data collection, i.e. once at baseline, which is 24 hours before the intervention, and twice after the intervention, specifically, 24 hours and 6 weeks post-intervention. Participants will be requested to chew on their swabs and spit into their containers at the following times: 1) immediately after waking up, 2) within 30 min after waking, and 3) immediately before going to sleep.
Measured: Up to 6 weeks
self-reported psychometric measures
The levels of perceived psychological stress levels will be assessed using the Perceived Stress Scale (PSS). This psychometric instrument has 14 items (see Appendices) that will be answered by the participants on a 5-point Likert scale. This scale has a demonstrated good reliability in healthy and clinical populations, and has a Chronbach's alpha value of 0.86109.
The severity of fear of cancer recurrence (FCR) is a good indicator for the level of negative emotional stress experienced. FCR Instrument is a 42 item multi-dimensional measure which specifically describes the amount of emotional stress experienced.
Cancer Behavior Inventory-Brief Version (CBI-B), a 12 item self-reported instrument to measures the level of self-efficacy among Cancer Survivors for their capacity to cope with cancer. All 12 items are rated on a 9-point likert scale that ranges from 1 ("not all confident") to 9 ("totally confident").
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionNov 2014
- Study completionJan 2016
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 Virginia Commonwealth 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brown, Ph.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888523
- Sponsor's protocol ID
- MCC-14971
- Status last verified
- Jan 2016
- First submitted
- 25 Jun 2013
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management for Cancer Survivors Using a Technologically Adapted Psychosocial Intervention: A Randomized Trial Determining the Effect of Expressive Writing on Psychoneuroimmunology Based Outcomes
- ClinicalTrials.gov ID
- NCT01888523
- Acronym / sponsor ID
- MCC-14971
- Conditions
- Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jun 2013 (estimated)
- 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.
Determine the efficacy of a brief and inexpensive psychosocial intervention, (called expressive writing) in improving health outcomes for cancer survivors.
Detailed description
This study aims to evaluate a computer-based stress-management therapy called expressive writing. This involves logging in to an online survey and writing in the survey about your thoughts and feelings about your cancer or to type in your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everyday experiences writing | Experimental | Behavioral: Everyday experiences writingInvolves logging in to an online survey and writing in the survey about your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples. |
| Expressive writing | Experimental | Behavioral: Expressive writingInvolves logging in to an online survey and writing in the survey about your thoughts and feelings about your cancer. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have completed their cancer radiation treatment (intent to cure),
- are cancer free, i.e. do not have currently have a diagnosis of primary/secondary cancer or any recurrence/relapse of cancer,
- are in the re-entry phase of cancer survivorship, i.e. 2-12 months post-treatment completion,
- have access to a computer and internet in a private setting, e.g. at home,
- are fluent in English,
Key exclusion criteria (5 listed)
- patients scheduled to undergo any type of cancer treatment (intent to cure/palliative) in the future (e.g. surgery after completing radiation),
- patients on any kind of corticosteroid medication (e.g. long-term prednisone therapy),
- patients having any condition that affects function of the adrenal glands (e.g. adrenal hyperplasia),
- patients with limited ability to produce saliva, e.g. patients that received radiation (or surgery) on the face region or on salivary glands; or patient's suffering from dry mouth (e.g. Sjögren's syndrome),
- patient's suffering from inflammation of the oral cavity (e.g. gingivitis).
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 writinglog in to an online survey and writing in the survey about your thoughts and feelings about your cancer. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples. | Behavioural | Expressive writing |
| Everyday experiences writinglog in to an online survey and writing in the survey about your thoughts and feelings about your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples. | Behavioural | Everyday experiences writing |
Primary outcome
salivary cortisol levels
Time frame: Up to 6 weeks
Participants will be asked to give their saliva samples through chewable swabs 3 times per day on every day of data collection, i.e. once at baseline, which is 24 hours before the intervention, and twice after the intervention, specifically, 24 hours and 6 weeks post-intervention. Participants will be requested to chew on their swabs and spit into their containers at the following times: 1) immediately after waking up, 2) within 30 min after waking, and 3) immediately before going to sleep.
2 secondary outcomes
salivary α-amylase and C-Reactive Protein (CRP)
Time frame: Up to 6 weeks
self-reported psychometric measures
Time frame: Up to 6 weeks
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 21 Jan 2016.
Related trials for Cancer Survivors
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
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.
Richard Brown, Ph.D. principal investigator
Virginia Commonwealth 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 and Everyday experiences writing in people with Cancer Survivors, run by Virginia Commonwealth 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 6 inclusion and 5 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 21 Jan 2016. 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?
salivary cortisol levels (time frame: Up to 6 weeks). 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 21 Jan 2016.