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A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01396174
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : April 17, 2015
Sponsor:
Collaborator:
Cancer Support Community, Research and Training Institute, Philadelphia
Information provided by (Responsible Party):
Temple University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: prosocial online support group Behavioral: Standard Online Support Group Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
Study Start Date : August 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Online Support Group Behavioral: Standard Online Support Group
Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will focus on encouraging self-expression.
Other Name: Life Beyond Cancer
Experimental: Prosocial Online Support Group Behavioral: prosocial online support group
Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will maximize opportunities to provide help to others.
Other Name: Life Beyond Cancer


Outcome Measures
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Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale [ Time Frame: change from baseline to one month post-intervention ]

Secondary Outcome Measures :
  1. Sense of Coherence measure [ Time Frame: change from baseline to one month post-intervention ]
    We are using the Meaningfulness/Purpose in Life subscale of the Sense of Coherence measure to assess sense of purpose.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396174


Locations
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United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
Cancer Support Community, Research and Training Institute, Philadelphia
Investigators
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Principal Investigator: Stephen J Lepore, Ph.D. Temple University
Study Director: Joanne Buzaglo, Ph.D. Cancer Support Community
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01396174    
Other Study ID Numbers: RCA158877A
First Posted: July 18, 2011    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015
Keywords provided by Temple University:
breast cancer
breast tumor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases