Cancer Survivors With Clinically Significant Distress Clinical Trial
Official title:
Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress
| Verified date | May 2014 |
| Source | Loma Linda University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 347 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. at least 18 years of age, 2. previous cancer diagnosis other than non-melanoma skin cancer, 4) 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Loma Linda University | Loma Linda | California |
| Lead Sponsor | Collaborator |
|---|---|
| Loma Linda University | National Institutes of Health (NIH) |
United States,
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* Note: There are 66 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in -Overall Psychological Functioning (OQ-45) | 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). | 3-month change | No |
| Primary | Change in-Center for Epidemiologic Studies Depress (CES-D) scale | 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. | 3-month change | No |
| Primary | Anxiety | 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). | 3-month change | No |
| Secondary | Fatigue | Fatigue subscale of the Profile of Mood States questionnaire | 3-month change | No |
| Secondary | Vigor | Vigor subscale of the Profile of Mood States questionnaire. | 3-month change | No |