Integrative Approaches For Cancer Survivorship 2: Project 1 (IACS2)

Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Individualized Integrative Medicine Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco, Osher Center for Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Medicine Intervention; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Anand Dhruva, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 21, 2018
• Study Completion (Actual): September 21, 2018

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 16-18567