Stress Management for Cancer Survivors Using a Technologically Adapted Psychosocial Intervention: A Randomized Trial Determining the Effect of Expressive Writing on Psychoneuroimmunology Based Outcomes
21 Years
N/A
Both
Cancer Survivors
Trial Information
Stress Management for Cancer Survivors Using a Technologically Adapted Psychosocial Intervention: A Randomized Trial Determining the Effect of Expressive Writing on Psychoneuroimmunology Based Outcomes
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
salivary cortisol levels
Outcome Description:
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.
Outcome Time Frame:
Baseline to 6 weeks
Safety Issue:
No
Principal Investigator
Richard Brown, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Virginia Commonwealth University
Authority:
United States: Institutional Review Board
Study ID:
MCC-14971
NCT ID:
NCT01888523
Start Date:
June 2013
Completion Date:
January 2015
Related Keywords:
- Cancer Survivors
Name | Location |
|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia 23298 |
