Know Cancer

forgot password

A Randomized Control Trial Testing the Efficacy of Professional and Peer-Led Online Support Groups for Young Canadian Breast Cancer Survivors

Phase 0
18 Years
45 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Randomized Control Trial Testing the Efficacy of Professional and Peer-Led Online Support Groups for Young Canadian Breast Cancer Survivors

Problem to be investigated: Innovative psychosocial interventions that enhance quality of
life as quickly and fully as possible are needed. The psychosocial burden of breast cancer
treatments and their sequelae are especially high for younger women (45 years and younger)
who are more likely to experience aggressive disease, multi-modal treatments, and higher
mortality rates. Psychosocial interventions that can assist women in their return to valued
activities and reduce suffering are urgently needed. Illness intrusiveness is a construct
and a measure describing the degree to which disease and treatments interfere and disrupt
important activities and commitments, and is a key component of quality of life. In previous
work, we demonstrated that an internet-delivered psychosocial intervention appeared to
reduce illness intrusiveness and distress at follow-up in preliminary pilot data.
Professional-led internet-delivered psychosocial interventions are showing promise but there
is a need to test efficacy, as well as to develop and test other, less costly interventions
that can be utilized by this and other cancer populations. Objectives: To test the efficacy
of a 12- week Professional-led Online Support Group plus Education (OSG+E) and a Peer-led
OSG+E compared to an Education-alone (E) intervention for reducing illness intrusiveness in
young breast cancer survivors, and to test a primary mediator, emotional processing.
Secondary objectives are to test additional outcomes, specifically, emotional distress,
emotional support, loneliness, self-efficacy and life satisfaction. A third objective is to
explore the role of two potential mediators of outcome, emotional suppression and social
constraint. Methodology: A 3-arm randomized controlled trial will be employed among Canadian
women 45 years of age and younger (N =210 ) who have completed primary treatment for breast
cancer. Measures of Illness Intrusiveness, Distress, Life Satisfaction, Self-efficacy,
Loneliness and Perceived Support will be collected at baseline, completion of treatment (3
months) and at 6 and 12 months. A form of random regression modeling will be used to create
individual slopes to test the primary hypotheses, while multiple regression analyses, based
on the MacArthur Model, will test the role of mediators. Significance of the research to
breast cancer: Women with breast cancer are using the internet for information gathering and
support, and this study will determine the efficacy of two forms of internet-delivered
interventions (Professional and Peer) for enhancing the adjustment process after primary
treatment is completed. Understanding of mediators will inform understanding of how to
enhance efficacy of the 2 models of OSG's. The results will be of value to women with breast
cancer as well as health care and community-based supportive care organizations.

Inclusion Criteria:

- less than 46 years old with primary breast cancer

Exclusion Criteria:

- older than 45 and in active treatment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Reduced anxiety

Outcome Description:

Psychological assessment measures given immediately following the 12 week group, and at 6 months and 12 months follow-up, will determine if one or both of the study groups effectively improve quality of life, reduce distress, and enhance self-efficacy and life satisfaction for young breast cancer survivors. Additionally, tests will be performed to investigate whether discussing emotional matters predicts greater improvements.

Outcome Time Frame:

1 year

Safety Issue:



Canada: Ethics Review Committee

Study ID:




Start Date:

April 2010

Completion Date:

March 2015

Related Keywords:

  • Breast Cancer
  • breast cancer
  • support groups
  • Primary diagnosis of breast cancer within the past three years.
  • Breast Neoplasms