Integrative Approaches to Cancer Survivorship: Project 3



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:April 17, 2018
End Date:February 2020

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Developing an Integrative Intervention for Breast Cancer Survivorship

The purpose of this study is to conduct a randomized controlled trial or RCT of the following
2 supportive care interventions in recent breast cancer survivors: an Integrative Medicine
intervention based on Ayurvedic medicine and a Health Education intervention.

Post-treatment cancer survivorship is often associated with a void in care given the drop-off
in support provided to survivors from the medical team as well as family and friends. In
addition, cancer associated symptoms and impaired quality of life remain significant problems
for patients despite advances in cancer treatment. Few effective treatment options exist for
these symptoms. Integrative medicine is rising in popularity in the United States; however,
few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of
medicine that originated in the Indian subcontinent, has its own system of diagnostics and
therapeutics, and among its strengths are wellness and prevention. In the Integrative
Medicine intervention, Ayurvedic nutrition and lifestyle guidance will be presented, along
with instruction in Yoga. In the Health Education intervention, informative content on issues
relevant to breast cancer survivors will be presented including the physical, social and
emotional impacts of survivorship. The investigators aim to perform a pilot RCT in breast
cancer survivors with impaired quality of life. Specifically, the investigators aim to assess
feasibility of randomization, adherence and retention to the Integrative Medicine and Health
Education interventions.

Inclusion Criteria:

- Female breast cancer survivor who is over 1 month and less than 24 months beyond the
completion of primary therapy (surgery, radiation, and chemotherapy)

- Having received chemotherapy as part of their primary therapy for breast cancer

- Be in complete remission

- Aged 18 years or older

- Able to read, write, and understand English

- Karnofsky Performance Status (KPS) greater than or equal to 60

- Have impaired quality of life

- Ability to give informed consent

Exclusion Criteria:

- Having received Ayurvedic treatment within 6 months of study enrollment

- Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2
directed therapy is not exclusionary.

- Being within 1 month (before or after) of surgery for breast cancer (including breast
reconstructive surgery). Smaller surgical procedures such as implant exchange are not
exclusionary.

- Patients on adjuvant hormone therapy for less than 2 months

- Have surgery for breast cancer or breast reconstructive surgery planned during the
initial 6 month study period. Smaller surgical procedures such as implant exchange are
not exclusionary.
We found this trial at
1
site
San Francisco, California 94115
Principal Investigator: Anand Dhruva, MD
Phone: 415-353-8072
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mi
from
San Francisco, CA
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