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Clinical Trial to Look at Effect of Online Decision Tool in Breast Cancer Patients

Navya and Tata Memorial Centre begin a randomized controlled trial to assess the Navya Patient Preference Tool. An online decision aid to help women with breast cancer choose between clinically equivalent treatments of mastectomy (complete removal of breast) and breast conservation therapy.

Navya, a Cambridge, Massachusetts and Bangalore, India based clinical informatics and patient services organization, is beginning a clinical trial that will explore the effects of an online decision tool for women faced with surgical decisions in early breast cancer. “Decision aids” are usually static information pamphlets used by the physician in clinic. Navya proposes an interactive and online decision aid that patients can use at home or while waiting to meet the surgeon in clinic. Further, Navya proposes a unique decision aid that accounts for the role the family plays in such decisions.  The Navya Patient Preference Tool looks to make the decision making process inclusive of the complete family by empowering all members with the necessary information.

Navya has teamed up with faculty from Harvard Business School (HBS) to answer questions regarding the influence of traditional gender roles, a woman’s centrality in her family unit, autonomy or deference of decisions to others, and the role of the male patriarch in the family. Leading faculty at HBS have studied the role of gender identity and how it impacts significant decisions in women’s lives. Through this study, Navya and HBS are applying their expertise to help women make more empowered and informed decisions with respect to her healthcare.

Estimates show that roughly 150,000 women in India are diagnosed with breast cancer every year and about half of them succumb to it.  However, in cases where cure is possible, the choice of therapy is often between Breast Conservation Therapy, (which includes Lumpectomy i.e. removal of only the cancerous lump but with mandatory radiation therapy) and Mastectomy (complete removal of breast with a 70% chance of avoiding radiation).  Both of these choices are clinically equivalent with respect to overall survival but have differences in quality of life related to cost or side effects of therapy, like radiation therapy.  Specifically, each choice presents its unique advantages and risks. The lumpectomy procedure aims to preserve the breast but may require additional surgery if the cancer recurs. Further, radiation is a mandatory step following surgery. By contrast, mastectomy removes the breast completely but is susceptible to a longer and more painful recovery period and numbness or tenderness along the scar. There is also a 30% chance that radiation will be necessary following the mastectomy surgery.

In order to make an informed choice, several decision aids are available but most are transplanted from the west. These decision aids often need a physician to administer them and hence available only in expert centers. Further, these do not account for the way decisions are made in families in the Indian context. They focus solely on providing information to the patient who, in many cases, may be but one of the stakeholders in a family based decision making process.

The tool Navya has created is an adaptive conjoint analysis based patient preference tool that is administered online and provides information to both the patient as well as a key male member in the family who may be involved in the decision. The tool is designed to reduce the conflict that arises from this decision and increase patient satisfaction. The study also explores traditional egalitarian gender roles and family embeddedness.

“It is imperative that informed decisions are being made when a woman chooses Breast Conservation Therapy or Mastectomy. This ensures that patients feel empowered and are aware of the various outcomes of such choices” says Dr Naresh Ramarajan, one of the creators of the tool and Chief Medical Officer of Navya. Dr. Rajendra Badwe, Director of Tata Memorial Centre, which will conduct this study with breast cancer patients of all demographic including variations in education and financial stratifications, said, “While women in western countries often make these decisions autonomously, that is not the case in India and other Asian countries where it is a collective decision made by the family elders. This study aims to empower all the stakeholders and also analyze the influences that impact such decisions.”

“We are proud to be partnered with Tata Memorial Center for this research study and are optimistic about the impact of this decision aid. It brings together best practices from developed countries and incorporates key insights that are necessary to make it work in the Indian value system” says Gitika Srivastava, Founder of Navya. Tata Memorial Centre will conduct the study with breast cancer patients of all demographic, including variations in education and financial stratifications.

 

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