Stress Management for Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Cancer Survivors
• Intervention / Treatment: Behavioral: Everyday experiences writing; Behavioral: Expressive writing

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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").	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Richard Brown, Ph.D., Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimate): June 27, 2013

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MCC-14971