Psychosocial Outcomes in Online Cancer Support Groups

NCT00382785 | Completed Results

• 1 other identifier: DDD#504604
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Specific Aim #1 is to determine if there is a difference in depressive symptoms between women with breast cancer assigned to one of two treatment conditions: moderated online support or peer-led online support.
2. 2.H1: Women with breast cancer who participate in moderated online support will report fewer depressive symptoms than women with breast cancer in peer led online support.
3. 3.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 two treatment conditions: moderated online support or peer-led online support.
4. 4.H2: Women with breast cancer who participate in moderated online support will report greater perceived social support than women with breast cancer in peer-led online support.
5. 5.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 two treatment conditions: moderated online support or peer-led online support.
6. 6.H3: Women with breast cancer who participate in moderated online support will report better quality of life than women with breast cancer in peer-led online support. NOTE: Once the study began, it was obvious that we could not prevent anyone from joining a support group, if that was her choice. We also could not control if participants joined a second online support group or face-to-face group during the study. Therefore, we decided to omit a "usual care" (no support) group. The study was completed with just two groups: moderated and peer-support.

Conditions

Breast Cancer

Keywords

online; support; breast cancer

Outcome Measures

Primary Outcomes (3)

• Scores on the Personal Resource Questionnaire 85.

  The Personal Resource Questionnaire 85 (PRQ85), Part II measures perceived social support and consists of 25 items in a seven-point Likert format which are rated from seven (7) strongly agree, to one (1) strongly disagree. Scores range from 25 to 175 with higher scores indicative of higher levels of perceived social support. Alpha reliability of the PRQ 85 has been demonstrated at \>.90

  16 weeks

• Scores on the CES-D Scale

  The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report scale widely used in the assessment of depression. Each item is given a rating of 0 to 3, with a potential range of 0 to 60 for the entire scale. Higher scores are associated with depression. The cutoff for the diagnosis of Major Depressive Disorder on the CES-D is 16. The instrument is a reliable measure (Alpha \>.85) of depression

  16 weeks

• Scores on the Quality of Life (QOL) Question on the Rotterdam Symptom Check List (RSCL).

  The Rotterdam Symptom Checklist (RSCL) measures quality of life in cancer patients. The RSCL checklist includes a QOL life question on a scale of 1 (excellent) to 7 (extremely poor). This was used as a measure of overall QOL.

  16 weeks

Study Arms (2)

moderated online support

EXPERIMENTAL

12-week online support led by a healthcare professional

Behavioral: moderated support

peer-led support

EXPERIMENTAL

12-week online support group in a peer-led format

Behavioral: peer-led

Interventions

moderated support BEHAVIORAL

one 12-week online support group led by a professional healthcare provider

moderated online support

peer-led BEHAVIORAL

12-week online support in a peer-led format

peer-led support

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

One limitation was the lack of a control group of women who did not take part in an online or face-to-face support group. The reasons for this are explained above.

Results Point of Contact

• Title: Paula Klemm, PhD, RN, OCN
• Organization: University of Delaware

klemmpa@udel.edu

(302) 831-8501

Study Officials

• Paula Klemm, PhD

  University of Delaware School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2006
• First Posted: October 2, 2006
• Study Start: September 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 21, 2010
• Results First Posted: December 21, 2010

Record last verified: 2010-11

Locations

US (1)