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Stress Management for Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01888523
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date January 21, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
salivary cortisol levels [ Time Frame: Baseline 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.
Change History Complete list of historical versions of study NCT01888523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2013)
  • salivary α-amylase and C-Reactive Protein (CRP) [ 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.
  • self-reported psychometric measures [ Time Frame: Up to 6 weeks ]
    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").
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • salivary α-amylase and C-Reactive Protein (CRP) [ Time Frame: Baseline 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.
  • self-reported psychometric measures [ Time Frame: Baseline and 6 weeks ]
    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. FCRI 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").
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress Management for Cancer Survivors
Official Title  ICMJE Stress Management for Cancer Survivors Using a Technologically Adapted Psychosocial Intervention: A Randomized Trial Determining the Effect of Expressive Writing on Psychoneuroimmunology Based Outcomes
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer Survivors
Intervention  ICMJE
  • Behavioral: Expressive writing
    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.
  • Behavioral: Everyday experiences writing
    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 Arms  ICMJE
  • Experimental: Everyday experiences writing
    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.
    Intervention: Behavioral: Everyday experiences writing
  • Experimental: Expressive writing
    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.
    Intervention: Behavioral: Expressive writing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2014)
40
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
60
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888523
Other Study ID Numbers  ICMJE MCC-14971
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Brown, Ph.D. Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP