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

• Sponsor: Loma Linda University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01976949
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 347
• Location: 1
• Arms: 2
• Duration (Months): 58
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivors With Clinically Significant Distress	Behavioral: online social-networking intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 347 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Social-networking intervention Individuals interested in participating in the study will be randomized to receive access to a 12-week internet-based treatment group. Subjects assigned to the treatment group will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group.	Behavioral: online social-networking intervention
Active Comparator: Control group 12 week wait-list control subjects will be able to join a group after they complete the 12-week assessment and will be asked to complete a 24-week assessment in order to measure change over time. Subjects will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group.	Behavioral: online social-networking intervention

Outcome Measures

Primary Outcome Measures

1. Change in -Overall Psychological Functioning (OQ-45) [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).

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

3. Anxiety [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 Outcome Measures

1. Fatigue [3-month change]

   Fatigue subscale of the Profile of Mood States questionnaire

2. Vigor [3-month change]

   Vigor subscale of the Profile of Mood States questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. at least 18 years of age,

2. previous cancer diagnosis other than non-melanoma skin cancer,

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University	Loma Linda	California	United States	92350

Sponsors and Collaborators

• Loma Linda University
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Jason E Owen, PhD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study website

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• Responsible Party: Jason Owen, Phd., Associate Professor, Loma Linda University
• ClinicalTrials.gov Identifier: NCT01976949
• Other Study ID Numbers: 57065; PA06-225
• First Posted: Nov 6, 2013
• Last Update Posted: May 22, 2014
• Last Verified: May 1, 2014

• Keywords provided by Jason Owen, Phd., Associate Professor, Loma Linda University: Cancer, social-networking intervention, cancer-related distress, internet health services, intervention delivery

Study Results

No Results Posted as of May 22, 2014