Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants received one-on-one breast cancer awareness education; one-on-one monthly Breast Self-Examination (BSE) training; general breast cancer screening recommendations; and general lifestyle modification recommendations

Participants received Standard care as described in the SC arm above in addition to individualized breast cancer risk assessment, individualized breast cancer risk counseling, and lifestyle risk reduction recommendations

Individualized breast cancer risk assessment: The Nigerian Breast Cancer Study (NBCS) absolute risk prediction model was used to predict the 5-year and lifetime breast cancer risks of the participants. The model utilized individual breast cancer risk factors.

Individualized breast cancer risk assessment

Individualized breast cancer risk counselling: The Principal Investigator (PI) and other trained risk counsellors discussed the results of the NBCS risk prediction model with participants and counselled them about the risk of developing breast cancer. The

Individualized breast cancer risk counselling

OLADOSUN A OJENGBEDE, FMCOG, FWACS, FICS, M.B.B.S

OLADELE O.O KALE, B.A, M.B, B.Ch, B.A.O

IKEOLUWAPO O. AJAYI, MBBS; PhD

CELIA IMARIA AGWAI, M.P.H; Ph.D.

DEZHENG HUO, PhD

OLUFUNMILAYO OLOPADE, M.D., F.A.C.P

The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are:

* What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology?
* What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria?
* What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria?

Participants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations.

We hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested.

For this study, first-degree female relatives are mothers, sisters, and daughters of BC patients

Nigerian Breast Cancer Risk-Reduction Study

Effects of Risk Assessment and Counselling on Adherence to Risk Reduction Recommendations Among Female Relatives of Breast Cancer Patients in Southwestern Nigeria

Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to breast screening practices

Questionnaire will be administered to the participants to determine the effects of the intervention on adherence to lifestyle risk reduction practices

Statistical analysis will be carried out to determined the independent variables predicting BSE

Statistical analysis will be carried out to determined the independent variables predicting first time to BC screening

Semi-structured questionnaires will be used to determine the perception of familial BC risk among participants

Semi-structured questionnaires will be used to determine the knowledge of familiar BC risk among participants

Semi-structured questionnaires will be used to determine the knowledge, attitude, and perception towards genetic testing and BC aetiology among participants

Lagos State University Teaching Hospital (LASUTH)

Obafemi Awolowo University Teaching Hospital

Lagos University Teaching Hospital (LUTH)

University College Hospital, Ibadan

University of Ibadan

Epidemiologist

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

In person general health, colorectal cancer risk information and screening recommendations.

Telephone general health counselling, colorectal cancer risk information and screening recommendations.

Standard care for 2 months followed by summary letter with general health information, colorectal cancer risk information and screening recommendations.

General health counselling and risk information

Mary Jane Esplen, PhD

Having at least one first-degree relative (FDR) with colon cancer increases an individual's risk of developing the disease. Many relatives of cancer patients are ineligible for genetic testing and, therefore, do not receive information from a healthcare provider about the disease. Providing relatives of cancer patients with information about their risk of developing colon cancer, screening information, and other colon-related health information, may increase knowledge and screening compliance as has been shown in relatives of breast cancer patients. The primary aim of this study is to test the efficacy of two modes (in-person vs. telephone) of providing a risk counseling and health promotion intervention for relatives of cancer patients on measures of knowledge of colon cancer risk and health-related factors, comprehension of risk, understanding of screening recommendations and intent to adopt an appropriate screening regimen. Participants will be randomized into one of three study arms (in-person, telephone, control). An assessment pre- and post- intervention will be conducted. In addition, longer-term follow-ups will be carried out two months and one year following the intervention to examine the sustainability of the intervention effect.

Colorectal cancer (CRC) is the second leading cause of cancer death in North America, despite being referred to as preventable and curable if detected early. Early detection through preventive screening has been found to decrease CRC death. However, adherence to CRC screening is poor, both in average risk and higher risk individuals. Lack of knowledge of CRC risk and screening recommendations, and psychological factors, such as perceived risk of CRC have been cited as important factors associated with screening compliance. By increasing knowledge and appropriate risk comprehension, it is possible to increase lifelong, long-term screening adherence, rather than one-time compliance. This is especially important because CRC screening can be unpleasant and if individuals are not clear of their risk and other important information about CRC, they may be reluctant to continue with a screening program. Having at least one first-degree relative (FDR) with CRC increases an individual's risk of developing the disease. Many relatives of CRC probands are ineligible for genetic testing and, therefore, do not receive information from a healthcare provider about the disease. Providing relatives of CRC probands with information about their risk of developing CRC, screening information, and other CRC-related health information, may increase knowledge and screening compliance as has been shown in relatives of breast cancer patients. Previous educational interventions with relatives of breast cancer probands have demonstrated increased knowledge, screening behaviour, risk comprehension, and decreased distress. While these interventions have been effective with relatives of breast cancer patients, these interventions have not been conducted to date with relatives of CRC patients. We believe that relatives of CRC patients could also benefit from this type of educational session. Educational interventions with relatives of breasts cancer patients have been conducted in-person, however in clinical genetic counseling, sessions are conducted both in-person and by telephone. Telephone counseling has become widespread in clinical services despite a lack of evidence to support its effectiveness compared to in-person counseling. Preliminary studies have shown that telephone interventions increase participation in screening programs, but few studies have directly compared telephone and in-person counseling. The primary aim of this study is to test the efficacy of two modes (in-person vs. telephone) of providing a risk counseling and health promotion intervention for relatives of CRC probands on measures of knowledge of CRC risk and health-related factors, comprehension of risk, understanding of screening recommendations and intent to adopt an appropriate screening regimen. Participants will be randomized into one of three study arms (in-person, telephone, control). An assessment pre- and post- intervention will be conducted. In addition, longer-term follow-ups will be carried out two months and one year following the intervention to examine the sustainability of the intervention effect.

A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients

Canadian Institutes of Health Research (CIHR)

University Health Network, Toronto

Supportive-Expressive Group Therapy

One in 10 Canadian women will be diagnosed with breast cancer (BC) and approximately 5% of all BC is believed to be hereditary. Women with a family history experience high levels of perceived risk for developing BC. Elevated risk perceptions for BC have been associated with psychological distress, which, in turn, can interfere with screening adherence. In our completed CBCRI-funded study, we developed and standardized a group intervention designed to address the psychological issues associated with having a family history of BC. Results demonstrated that the intervention led to significant improvement in levels of anxiety and depression, improved BC risk factors/genetics knowledge and was associated with optimal screening behavior. The proposed study will rigorously test the group intervention in comparison to standard risk counselling in a sample of 150 women recruited from Familial BC clinics in Toronto. The interventions will be examined for their impact on a) psychological functioning, b) BC risk/genetic knowledge and c) screening behaviors.

Keywords: Breast cancer, genetics, psychotherapy, group counselling, randomized control trial, risk counselling, women's mental health, familial breast cancer.

One in 10 Canadian women will be diagnosed with breast cancer (BC) and approximately 5% of all BC is believed to be hereditary. Women with a family history of BC experience high levels of perceived risk and vulnerability for developing BC. Elevated risk perceptions for BC are difficult to modify and have been associated with psychological distress that, in turn, can interfere with screening adherence. The specific objectives of the current randomized trial are to determine the effects of a supportive-expressive group intervention on a) psychosocial functioning (using standardized instruments), b) BC risk/genetic knowledge and c) screening behaviors in women with a family history of breast cancer receiving standard genetic risk counseling. Preliminary data will be collected to examine the cost effectiveness of the intervention.

The study is being conducted in the following University of Toronto affiliated teaching hospitals: Mount Sinai Hospital; Preventive Oncology Program, Sunnybrook and Women's College Health Sciences; Toronto Sunnybrook Regional Cancer Centre; University Health Network; North York General Hospital; Credit Valley Hospital. A total of 150 women with a family history of BC will be randomized in a ratio of 2 to 1 to participate in an 8 weekly/ 4 monthly support group or to a control arm that receives educational materials.

The study has been funded by the Canadian Breast Cancer Research Initiative (CBCRI) of the National Cancer Institute of Canada since 2001. To date 66 women have been enrolled in the study and we anticipate a total of 90 women will be enrolled by the end of the current funding year in June 2004. At this rate it is expected that recruitment will be completed in June 2005, the last intervention groups will be completed by January 2006 and that analysis of the final study results will be completed by June 2006. Analysis of baseline data will begin in September 2005 once the last study groups have been initiated and a manuscript reporting the final results will be prepared by June 2006. Two years of funding is requested for these activities.

Significance: Technological advances in molecular biology and genetics are occurring rapidly. Our proposed research has direct relevance for advancing knowledge on the communication and provision of risk/genetic information to individuals with a family history of BC and has both direct and indirect relevance to individuals at all stages of cancer. Improved counselling techniques for those with a family history may impact on the prevention and management of BC through improved surveillance and preventive techniques, enhanced psychosocial functioning and wellbeing through increased psychological resilience. In addition, effective risk counselling interventions may facilitate the understanding of and decision-making around genetic testing, and the adjustment to a cancer diagnosis, should these women with family histories later develop the disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nigerian Breast Cancer Risk-Reduction Study	NCT05834933	Risk Reduction ... Breast Cancer Health Behavior Health Care Uti... Health Knowledg...	Individualized ... Individualized ...	20 Years - 75 Years	University of Ibadan
A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients	NCT00188305	Colon Cancer Colonic Neoplas...	General health ...	25 Years - 65 Years	University Health Network, Toronto
A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients	NCT00188305	Colon Cancer Colonic Neoplas...	General health ...	25 Years - 65 Years	University Health Network, Toronto
RCT of a Group Intervention for Women With a Family History of Breast Cancer	NCT00150917	Breast Neoplasm...	Supportive-Expr...	18 Years - 70 Years	University Health Network, Toronto
Nigerian Breast Cancer Risk-Reduction Study	NCT05834933	Risk Reduction ... Breast Cancer Health Behavior Health Care Uti... Health Knowledg...	Individualized ... Individualized ...	20 Years - 75 Years	University of Ibadan

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