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Psychosocial Outcomes in Online Cancer Support Groups
This study is currently recruiting participants.
Verified by Christiana Care Health Services, January 2009
First Received: September 28, 2006   Last Updated: January 26, 2009   History of Changes
Sponsored by: Christiana Care Health Services
Information provided by: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00382785
  Purpose

Purpose: The purpose of this project is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. This objective will be addressed by the following specific aims:

Specific Aims:

  1. Specific Aim #1 is to determine if there is a difference in depressive symptoms between women with breast cancer assigned to one of three treatment conditions: facilitated online support, non-facilitated online support, or usual care.

    • H1a: Women with breast cancer who participate in online support will report fewer depressive symptoms than women with breast cancer in usual care.
    • H1b: Women with breast cancer who participate in facilitated online support will report fewer depressive symptoms than women with breast cancer who participate in non-facilitated online support.
  2. Specific Aim #2 is to determine if there is a difference in perceived social support between women with breast cancer who are assigned to one of three treatment conditions: facilitated online support, non-facilitated online support, or usual care.

    • H2a: Women with breast cancer who participate in online support will report greater perceived social support than women with breast cancer in usual care.
    • H2b: Women with breast cancer who participate in facilitated online support will report greater perceived social support than women with breast cancer who participate in non-facilitated online support.
  3. Specific Aim #3 is to determine if there is a difference in quality of life in women with breast cancer who are assigned to one of three treatment conditions: facilitated online support, non-facilitated online support, or usual care.

    • H3a: Women with breast cancer who participate in online support will report better quality of life than women with breast cancer in usual care.
    • H3b: Women with breast cancer who participate in facilitated online support will report better quality of life than women with breast cancer who participate in non-facilitated online support.

Condition Intervention
Breast Cancer
Behavioral: Type of online support group

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: Psychosocial Outcomes in Online Cancer Support Groups

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Social support [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Depressive Symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Type of online support group
    Subjects will be assigned to a facilitated or unfacilitated online support group or usual care (no support group)
Detailed Description:

Purpose/Specific Aims: The purpose of this randomized three-group longitudinal study is to evaluate whether psychosocial outcomes in women with breast cancer differ based on the format of online group support. Rationale/Significance of study: No research has explored differences in psychosocial outcomes between online support groups that use a professional facilitator, those that use a non-facilitated (self-help) format, and a control group. This study will address one of the goals put forth in the 2003-2005 ONS Research Agenda, by studying the effects of technology based interventions (online support) on psychosocial outcomes (depression, perceived social support, quality of life) in women with breast cancer. This work will add to the nursing research base with regard to online support for women with breast cancer and provide a springboard for additional studies to enhance the research base. Conceptual Framework: The concept of openness, based on the mutual interaction between human beings and their environment, and emphasized in Rogers' Science of Unitary Human Beings provides a basis for this project. The research will utilize three different support environments and measure how interactions in each affect psychosocial outcomes over time. Main Research Variables: The independent variables are three treatment conditions (facilitated online support, non-facilitated online support, and usual care). The dependent variables are depression, perceived social support, and quality of life. Design: A randomized longitudinal design, comparing two types of online support groups and a usual care group, on the basis of three principal measures will be used. Each measure will be obtained at baseline and at three later timepoints. Setting: Support groups will be accessed from secure and password protected university web pages devoted exclusively to this study. Sample: Sixty women with breast cancer, at least 21 years of age, who have Internet access will be recruited. Methods: Women will be randomly assigned to one of the three treatment conditions (facilitated online support, non-facilitated online support, or usual care) given a password, and instructed to complete a Demographic Form and the study questionnaires online. All subjects will be asked to complete the study questionnaires again at 6, 12, and 16 weeks. Facilitated groups will run in a semi-structured format over 12 weeks, with a different discussion topic moderated each week by the facilitator. Non-facilitated groups will be run in a peer support format over 12 weeks. Usual care (control group) will not be assigned to a support condition. Implications for practice: Women with breast cancer are turning to online resources for support. Nurses should be aware of the benefits/limitations of this support alternative. A cost benefit may be suggested if it is shown that non-facilitated online support has psychosocial benefits similar to professionally facilitated groups. Additional research is needed to explore the impact of online support on psychosocial outcomes in people with other cancers, minorities, and men. This study will add important information to the research base regarding online support groups and help determine the best strategy for online cancer support.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Clinical diagnosis of breast cancer

  • Female
  • At least 21 years of age
  • Internet access; Able to read and write English
  • Have completed treatment for breast cancer in the past 36 months or are receiving treatment
  • Do not currently belong to an online or face-to-face cancer support group
  • Internet access

Exclusion Criteria:

  • Male
  • not diagnosed with breast cancer
  • under 21 years of age
  • received treatment more than 36 months ago for breast cancer
  • no Internet access
  • unable to read and write English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382785

Contacts
Contact: Paula R. Klemm, PhD (302) 831-8501 klemmpa@udel.edu

Locations
United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19716
Contact: Paula Klemm, DNSc     302-831-8501     klemmpa@udel.edu    
Principal Investigator: Paula Klemm, DNSc            
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Paula Klemm, PhD University of Delaware School of Nursing
  More Information

No publications provided

Responsible Party: University of Delaware School of Nursing ( Paula Klemm, PhD, RN, OCN )
Study ID Numbers: DDD#504604
Study First Received: September 28, 2006
Last Updated: January 26, 2009
ClinicalTrials.gov Identifier: NCT00382785     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
online
support
breast cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009