search
Back to results

A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prosocial online support group
Standard Online Support Group
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring breast cancer, breast tumor

Eligibility Criteria

21 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Online Support Group

Prosocial Online Support Group

Arm Description

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale

Secondary Outcome Measures

Sense of Coherence measure
We are using the Meaningfulness/Purpose in Life subscale of the Sense of Coherence measure to assess sense of purpose.

Full Information

First Posted
July 13, 2011
Last Updated
April 16, 2015
Sponsor
Temple University
Collaborators
Cancer Support Community, Research and Training Institute, Philadelphia
search

1. Study Identification

Unique Protocol Identification Number
NCT01396174
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Cancer Support Community, Research and Training Institute, Philadelphia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast cancer, breast tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Online Support Group
Arm Type
Active Comparator
Arm Title
Prosocial Online Support Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
prosocial online support group
Other Intervention Name(s)
Life Beyond Cancer
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Online Support Group
Other Intervention Name(s)
Life Beyond Cancer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Time Frame
change from baseline to one month post-intervention
Secondary Outcome Measure Information:
Title
Sense of Coherence measure
Description
We are using the Meaningfulness/Purpose in Life subscale of the Sense of Coherence measure to assess sense of purpose.
Time Frame
change from baseline to one month post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Lepore, Ph.D.
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanne Buzaglo, Ph.D.
Organizational Affiliation
Cancer Support Community
Official's Role
Study Director
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25403218
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.
Results Reference
background
PubMed Identifier
21867502
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.
Results Reference
derived

Learn more about this trial

A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors

We'll reach out to this number within 24 hrs