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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

Brief Summary:
Determine the efficacy of a brief and inexpensive psychosocial intervention, (called expressive writing) in improving health outcomes for cancer survivors.

Condition or disease Intervention/treatment Phase
Cancer Survivors Behavioral: Expressive writing Behavioral: Everyday experiences writing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Study Start Date : February 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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").




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888523


Locations
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United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Richard Brown, Ph.D. Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01888523     History of Changes
Other Study ID Numbers: MCC-14971
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016