Limits...
How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer.

Watts KJ, Meiser B, Mitchell G, Kirk J, Saunders C, Peate M, Duffy J, Kelly PJ, Gleeson M, Barlow-Stewart K, Rahman B, Friedlander M, Tucker K, TFGT Collaborative Gro - BMC Cancer (2012)

Bottom Line: Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT.Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret.A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Medical Oncology, Prince of Wales Hospital, High Street, Randwick, NSW, Australia. k.watts@unsw.edu.au

ABSTRACT

Background: Germline BRCA1 and BRCA2 mutation testing offered shortly after a breast cancer diagnosis to inform women's treatment choices - treatment-focused genetic testing 'TFGT' - has entered clinical practice in specialist centers and is likely to be soon commonplace in acute breast cancer management, especially for younger women. Yet the optimal way to deliver information about TFGT to younger women newly diagnosed with breast cancer is not known, particularly for those who were not suspected of having a hereditary breast cancer syndrome prior to their cancer diagnosis. Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT. This trial aims to examine the impact and efficiency of two models of educating younger women newly diagnosed with breast cancer about genetic testing in order to provide evidence for a safe and effective future clinical pathway for this service.

Design/methods: In this non-inferiority randomized controlled trial, 140 women newly diagnosed with breast cancer (aged less than 50 years) are being recruited from nine cancer centers in Australia. Eligible women with either a significant family history of breast and/or ovarian cancer or with other high risk features suggestive of a mutation detection rate of > 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.

Discussion: This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.

Show MeSH

Related in: MedlinePlus

Study design and recruitment flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC3472271&req=5

Figure 2: Study design and recruitment flow.

Mentions: This is a multicenter randomized controlled trial which is being conducted at nine hospital sites located in three states in Australia (New South Wales, Victoria and Queensland) in two stages. The study protocol adheres to CONSORT guidelines [29]. The study design is presented in Figure 2. In Stage I, 140 eligible patients are being randomized to receive either EM or SC. Randomization is in a 1:1 ratio and is achieved through a computerized random sequence, which is generated by an independent person. Each number in the sequence is printed and placed in an unmarked envelope such that allocation is concealed from the study coordinator until randomization occurs. It is not possible to blind participants to their allocation because they become aware of it once the genetics staff arrange patients’ genetic counseling appointments. The primary outcome measurement is level of decisional conflict regarding TFGT. The secondary behavioral and psychological outcome measures include: (i) uptake of TFGT; (ii) uptake of BM; (iii) cancer-specific distress; (iv) general anxiety and depression; (v) distress associated with decision to have genetic testing; (vi) level of decision regret regarding TFGT and surgical decisions, and (vii) family involvement in decision-making. Over the course of the study, four questionnaires will be administered: at baseline (prior to randomization); one week after receiving education about TFGT; 3 weeks after receipt of genetic testing result (or at the equivalent time point for those who do not have genetic testing or who choose not to receive their test result); and 12 months after study enrolment.


How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer.

Watts KJ, Meiser B, Mitchell G, Kirk J, Saunders C, Peate M, Duffy J, Kelly PJ, Gleeson M, Barlow-Stewart K, Rahman B, Friedlander M, Tucker K, TFGT Collaborative Gro - BMC Cancer (2012)

Study design and recruitment flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3472271&req=5

Figure 2: Study design and recruitment flow.
Mentions: This is a multicenter randomized controlled trial which is being conducted at nine hospital sites located in three states in Australia (New South Wales, Victoria and Queensland) in two stages. The study protocol adheres to CONSORT guidelines [29]. The study design is presented in Figure 2. In Stage I, 140 eligible patients are being randomized to receive either EM or SC. Randomization is in a 1:1 ratio and is achieved through a computerized random sequence, which is generated by an independent person. Each number in the sequence is printed and placed in an unmarked envelope such that allocation is concealed from the study coordinator until randomization occurs. It is not possible to blind participants to their allocation because they become aware of it once the genetics staff arrange patients’ genetic counseling appointments. The primary outcome measurement is level of decisional conflict regarding TFGT. The secondary behavioral and psychological outcome measures include: (i) uptake of TFGT; (ii) uptake of BM; (iii) cancer-specific distress; (iv) general anxiety and depression; (v) distress associated with decision to have genetic testing; (vi) level of decision regret regarding TFGT and surgical decisions, and (vii) family involvement in decision-making. Over the course of the study, four questionnaires will be administered: at baseline (prior to randomization); one week after receiving education about TFGT; 3 weeks after receipt of genetic testing result (or at the equivalent time point for those who do not have genetic testing or who choose not to receive their test result); and 12 months after study enrolment.

Bottom Line: Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT.Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret.A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Medical Oncology, Prince of Wales Hospital, High Street, Randwick, NSW, Australia. k.watts@unsw.edu.au

ABSTRACT

Background: Germline BRCA1 and BRCA2 mutation testing offered shortly after a breast cancer diagnosis to inform women's treatment choices - treatment-focused genetic testing 'TFGT' - has entered clinical practice in specialist centers and is likely to be soon commonplace in acute breast cancer management, especially for younger women. Yet the optimal way to deliver information about TFGT to younger women newly diagnosed with breast cancer is not known, particularly for those who were not suspected of having a hereditary breast cancer syndrome prior to their cancer diagnosis. Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT. This trial aims to examine the impact and efficiency of two models of educating younger women newly diagnosed with breast cancer about genetic testing in order to provide evidence for a safe and effective future clinical pathway for this service.

Design/methods: In this non-inferiority randomized controlled trial, 140 women newly diagnosed with breast cancer (aged less than 50 years) are being recruited from nine cancer centers in Australia. Eligible women with either a significant family history of breast and/or ovarian cancer or with other high risk features suggestive of a mutation detection rate of > 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.

Discussion: This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.

Show MeSH
Related in: MedlinePlus