A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Temple University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cancer Support Community, Research and Training Institute, Philadelphia
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01396174
First received: July 13, 2011
Last updated: December 6, 2012
Last verified: July 2011
  Purpose

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 Intervention
Breast Neoplasms
Behavioral: prosocial online support group
Behavioral: Standard Online Support Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale [ Time Frame: change from baseline to one month post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sense of Coherence measure [ Time Frame: change from baseline to one month post-intervention ] [ Designated as safety issue: No ]
    We are using the Meaningfulness/Purpose in Life subscale of the Sense of Coherence measure to assess sense of purpose.


Estimated Enrollment: 180
Study Start Date: August 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years to 64 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396174

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

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01396174     History of Changes
Other Study ID Numbers: RCA158877A
Study First Received: July 13, 2011
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
breast cancer
breast tumor

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014