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

Loma Linda University (LLU)

Status: Completed

Conditions: Cancer Survivors With Clinically Significant Distress

Treatments: Behavioral: online social-networking intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01976949

PA06-225 (Other Grant/Funding Number)

57065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 347 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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347 participants in 2 patient groups

Social-networking intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: online social-networking intervention

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: online social-networking intervention