A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors

Breast Neoplasms Clinical Trial

Official title:

A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396174
• Other study ID #: RCA158877A
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: April 16, 2015
• Start date: August 2011
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Cancer Support Community, Research and Training Institute, Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale		change from baseline to one month post-intervention	No
Secondary	Sense of Coherence measure	We are using the Meaningfulness/Purpose in Life subscale of the Sense of Coherence measure to assess sense of purpose.	change from baseline to one month post-intervention	No