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Clinical Trials/NCT01976949
NCT01976949
Completed
Not Applicable

Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress

Loma Linda University1 site in 1 country347 target enrollmentJuly 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Survivors With Clinically Significant Distress
Sponsor
Loma Linda University
Enrollment
347
Locations
1
Primary Endpoint
Change in -Overall Psychological Functioning (OQ-45)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life.

Detailed Description

Individuals with cancer face an array of psychosocial needs, and it has been estimated that up to 35% of cancer survivors experience clinically-significant levels of distress. Psychosocial interventions may be effective for improving quality of life and reducing levels of mood disturbance in these patients. Unfortunately, barriers to accessing psychosocial intervention are common, and many are unable to access those services. Internet- based psychosocial interventions improve accessibility of care and offer additional methodological advantages, including the ability to easily collect self-report data, track exposure to the intervention, and evaluate effects of specific intervention components. The proposed study will evaluate whether a website developed specifically for providing psychological treatment and enhancing communication between cancer survivors can improve distress among cancer survivors who indicate that they have high levels of distress. If successful, the study will also provide valuable information needed to improve the treatment and to adequately conduct a larger trial comparing internet-based and face-to-face treatments.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason Owen, Phd.

Associate Professor

Loma Linda University

Eligibility Criteria

Inclusion Criteria

  • at least 18 years of age,
  • previous cancer diagnosis other than non-melanoma skin cancer,
  • fluent in English, 5) routine access to the Internet, and 6) presence of greater than mild distress as identified by having distress greater than or equal to 4 on initial screening with the Distress Thermometer

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in -Overall Psychological Functioning (OQ-45)

Time Frame: 3-month change

The OQ-45 measures the global functioning of a client and is composed of 3 subscales that measure subjective discomfort (intrapsychic functioning), interpersonal relationships, and social role performance. The OQ-45 has adequate internal consistency (a = .93) and reliability (r = .84) (Lambert, et al., 2004).

Change in-Center for Epidemiologic Studies Depress (CES-D) scale

Time Frame: 3-month change

The CES-D is a self-report measure that consists of 20 items rated on a 4-point Likert scale to assess depressive symptoms experienced in the previous week. The CES-D has demonstrated excellent reliability and validity (Radloff, 1977). The standard cutoff score of 16 will be used to identify depression.

Anxiety

Time Frame: 3-month change

Anxiety subscale of the brief Profile of Mood States (b-POMS; Shacham, 1983), which utilizes 37 descriptive mood adjectives to describe how a participant felt during the past week on a 5-point Likert scale. Specifically look at anxiety (anx subscale of POMS), vigor (subscale of POMS), and fatigue (subscale of POMS).

Secondary Outcomes

  • Vigor(3-month change)
  • Fatigue(3-month change)

Study Sites (1)

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