NCT01888523

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

June 25, 2013

Last Update Submit

January 20, 2016

Conditions

Cancer Survivors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • salivary α-amylase and C-Reactive Protein (CRP)

    Up to 6 weeks

  • self-reported psychometric measures

    Up to 6 weeks

Study Arms (2)

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.

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.

Behavioral: Expressive writing

Interventions

Expressive writingBEHAVIORAL

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.

Expressive writing
Everyday experiences writingBEHAVIORAL

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.

Everyday experiences writing

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

Study Officials

  • Richard Brown, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2013

First Posted

June 27, 2013

Study Start

February 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

US(1)