Clinical trial NCT01396174: A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
Official title: A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: breast cancer
breast tumor
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Cancer Support Community, Research and Training Institute, Philadelphia
First posted: 2011-07-18
Enrollment: 184
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that breast cancer survivors participating in a prosocial online support group will have a significantly lower mean level of psychological symptoms (anxiety/depression) and higher mean level of sense of purpose post-intervention than participants in a standard online support group.

Detailed description: Psychological distress is a significant problem among breast cancer survivors. Many survivors turn to the internet for information and support, yet few controlled studies have examined the effectiveness and safety of online support groups. The investigators are testing the potential efficacy, acceptability, and feasibility of an innovative theory-based online support group (OSG) for breast cancer survivors. Members of the control group will participate in a standard OSG that encourages self-expression. Members of the experimental condition will participate in a prosocial OSG that provides structured helping opportunities and coaching on how best to give support to others. Participants will complete two telephone interviews and six weekly online support group meetings.

Eligibility criteria: Inclusion Criteria:

* diagnosed with stage I or II breast cancer in preceding 36 months
* 21-64 years of age
* access to and ability to use a computer and the internet to communicate with others
* fluent in spoken English
* meet the screening criteria for psychological distress (score \>7 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scales

Exclusion Criteria:

* currently taking medication for depression

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: change from baseline to one month post-intervention
Secondary outcomes:
measure: Sense of Coherence measure
timeFrame: change from baseline to one month post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Stephen J Lepore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Support Community
name: Joanne Buzaglo, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Lepore SJ, Buzaglo JS, Lieberman MA, Golant M, Greener JR, Davey A. Comparing standard versus prosocial internet support groups for patients with breast cancer: a randomized controlled trial of the helper therapy principle. J Clin Oncol. 2014 Dec 20;32(36):4081-6. doi: 10.1200/JCO.2014.57.0093. Epub 2014 Nov 17.
citation: Lepore SJ, Buzaglo JS, Lieberman MA, Golant M, Davey A. Standard versus prosocial online support groups for distressed breast cancer survivors: a randomized controlled trial. BMC Cancer. 2011 Aug 25;11:379. doi: 10.1186/1471-2407-11-379.