Integrative Approaches For Cancer Survivorship 2: Project 1

NCT02897635 | Completed DMC

• 1 other identifier: 16-18567
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in fatigue over 12 months

  Baseline, 3 months, 6 months, 12 months

• Change in sleep quality over 12 months

  Baseline, 3 months, 6 months, 12 months

• Change in anxiety over 12 months

  Baseline, 3 months, 6 months, 12 months

• Change in depressive symptoms over 12 months

  Baseline, 3 months, 6 months, 12 months

• Change in pain over 12 months

  Baseline, 3 months, 6 months, 12 months

Study Arms (1)

Integrative Medicine Intervention

EXPERIMENTAL

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

Interventions

Individualized Integrative Medicine Intervention BEHAVIORAL

Integrative Medicine 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 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

You may not qualify if:

• Having received Ayurvedic treatment within 6 months of study enrollment
• Patients on adjuvant hormone therapy for less than 2 months

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

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; 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: September 7, 2016
• First Posted: September 13, 2016
• Study Start: September 1, 2016
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Locations

US (1)