What is the purpose of this study?
Breast cancer is the most common type of cancer for Canadian women. Most women who survive breast cancer cope well after the initial treatment such as surgery, radiation and chemotherapy finishes. However for some women, there can be ongoing concerns with some of the changes that can happen, in terms of body image, intimate relationships and a sense of loss or grief.
We are testing a support group intervention to assist women who have these concerns, to help in moving forward after breast cancer. Over 200 women will be participating in this study.
If the results of the study are promising, this type of group program could be integrated into cancer centres and therefore, help other women coping with breast cancer with these issues.
If I am interested in participating, what would I have to do?
- You will be first asked some questions by one of our study coordinators to determine your eligibility to participate. You’ll have an opportunity also to ask questions that you might have about the study in general.
- Secondly, you will be asked to meet with one of the group leaders before officially enrolling in this study. The group leader will talk with you about your medical history as well as explain the study in detail and answer any questions you may have. The meeting will last for about an hour. At the end of the meeting, you will be asked to sign a consent form to participate in this research study. Our group leaders are located at either the University Health Network in downtown Toronto or at Sunnybrook Health Sciences Centre, in mid-town Toronto. You will be compensated for your parking expenses when attending this meeting
- After you officially enroll into the study, we will ask you to complete a questionnaire package which will take about an hour to complete.
- You will then be randomly selected (by a computer) to either the group intervention OR the control arm (educational materials only). There is a 2 to 1 chance that you will be selected for the group intervention arm. This means that for every 15 women recruited into the study, 10 will be randomly selected to the group intervention and 5 will be randomly selected to the control arm.
- If you are selected to the group intervention arm, you will be asked to attend a weekly group session which lasts for 90 minutes for eight consecutive weeks at either Sunnybrook Health Centre or Princess Margaret Hospital in Toronto. You will be compensated for your parking expenses if you are attending the group intervention.
- At the end of eight weeks, we will ask you to complete a second questionnaire (this includes both the women in the group intervention arm and control arm)
- We’ll ask you to complete the questionnaires again at six months after enrolling into the study, and lastly at one year after your enrollment.
Who is eligible to take part in this study?
- Women who have been diagnosed at anytime in the past with breast cancer (Stage I-III)
- No evidence of metastasis (spread of breast cancer to other body organs)
- Had either a mastectomy or lumpectomy (with or without breast reconstruction)
- Completed or nearing the end of chemotherapy and/or radiation treatment
- Have concerns about body image and relationships and are interested in exploring these issues in a group format
It is important to note that, as this study is located in Toronto, there is some attendance required in the city, especially if you are randomly selected to the group intervention.
This study is funded by the Canadian Breast Cancer Research Alliance
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