Integrative Approaches for Cancer Survivorship

NCT01488123 | Completed

• 2 other identifiers: A1123135K23AT005340-03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a four-month manualized Ayurvedic intervention will improve quality of life in recent breast cancer survivors.

Conditions

Breast Cancer

Keywords

Breast, Cancer, Survivorship, Integrative, Complementary

Outcome Measures

Primary Outcomes (1)

• Change in quality of life over 16 weeks

  The investigators will use the EORTC QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) 68 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.

  Baseline, End of week 8, End of week 16

Study Arms (1)

Ayurvedic Intervention

EXPERIMENTAL

Behavioral: Individualized manualized Ayurvedic intervention

Interventions

Individualized manualized Ayurvedic intervention BEHAVIORAL

The manualized intervention will begin with an initial clinic visit (approximately 90 minutes) with the Ayurvedic practitioner in which the patient's diagnosis will be determined, an overview of Ayurveda will be given, and the initial treatment will be recommended based on the Ayurvedic diagnosis. Follow-up visits will range between 30 and 60 minutes in duration. The treatment modalities employed in the study will include nutrition, lifestyle, yoga, and marma (a treatment similar to acupressure).

Ayurvedic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer survivor who is over 1 month and less than 12 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 a complete remission
• Aged 18 years or older
• Able to read, write, and understand English
• Karnofsky Performance Status (KPS) 67 greater than 60.
• Ability to give informed consent

You may not qualify if:

• Having received Ayurvedic treatment within 2 months of study enrollment
• Patients on adjuvant hormone therapy for less than 1 month

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California, San Francisco, Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anand Dhruva, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2015
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)