Integrative Approaches For Cancer Survivorship 2: Project 1

Study Overview
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Brief Summary
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The purpose of this study is to develop and test a 12-month Integrative Medicine intervention based on Ayurvedic medicine in recent breast cancer survivors.

Detailed Description
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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. The investigators aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to refine the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

Official Title
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Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Individualized Integrative Medicine Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Medicine Intervention<br>Study participants will attend 14 visits with an integrative medicine clinician over the course of 6 months followed by a 6 month maintenance phase. The treatment modalities employed in the study will include nutrition and lifestyle recommendations. | Behavioral: Individualized Integrative Medicine Intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life over 12 months | The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a Breast Cancer-Specific Subscale (BR23) to collect data on qualify of life and cancer-related symptoms. | Baseline, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue over 12 months | The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue. | Baseline, 3 months, 6 months, 12 months | 
| Change in sleep quality over 12 months | The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance. | Baseline, 3 months, 6 months, 12 months | 
| Change in anxiety over 12 months | The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety. | Baseline, 3 months, 6 months, 12 months | 
| Change in depressive symptoms over 12 months | The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms. | Baseline, 3 months, 6 months, 12 months | 
| Change in pain over 12 months | The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function. | Baseline, 3 months, 6 months, 12 months | 
| Change in diet over 12 months | The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period. | Baseline, 3 months, 6 months, 12 months |