NCT01396174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

3.3 years

First QC Date

July 13, 2011

Last Update Submit

April 16, 2015

Conditions

Keywords

breast cancerbreast tumor

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale

    change from baseline to one month post-intervention

Secondary Outcomes (1)

  • Sense of Coherence measure

    change from baseline to one month post-intervention

Study Arms (2)

Standard Online Support Group

ACTIVE COMPARATOR
Behavioral: Standard Online Support Group

Prosocial Online Support Group

EXPERIMENTAL
Behavioral: prosocial online support group

Interventions

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.

Also known as: Life Beyond Cancer
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 focus on encouraging self-expression.

Also known as: Life Beyond Cancer
Standard Online Support Group

Eligibility Criteria

Age21 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with stage I or II breast cancer in preceding 36 months
  • 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

You may not qualify if:

  • currently taking medication for depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (2)

  • 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.

    PMID: 25403218BACKGROUND
  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Stephen J Lepore, Ph.D.

    Temple University

    PRINCIPAL INVESTIGATOR
  • Joanne Buzaglo, Ph.D.

    Cancer Support Community

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 18, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations