Integrative Approaches for Cancer Survivorship (IACS3)

Summary

This clinical trial is a two-arm pilot randomized controlled trial for non-metastatic breast cancer survivors to determine the feasibility, acceptability, and fidelity of two integrative health approaches and study design in a multi-site setting. Participants (n=104) will be randomized to either the Ayurveda Intervention (AVI) or Facing Forward Health Education Intervention (FFHEI). Integrative health combines biomedical and complementary approaches together in a coordinated way. AVI, a multi-modal intervention, includes nutritional education, lifestyle practices, yoga, and therapeutic touch, called marma, to help the body and mind feel balanced. FFHEI provides health education using self-directed online content and interactive videos based on the latest science in cancer survivorship. This study does not intend to conduct tests of efficacy and is focused on feasibility outcomes.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8

Interventions

BEHAVIORAL

Nutrition Education

Given nutrition education

BEHAVIORAL

Lifestyle Counseling

Given lifestyle recommendations

OTHER

Yoga

Participate in yoga

PROCEDURE

Marma therapy

Participate in marma therapeutic touch

OTHER

Educational Intervention

Attend online HEI sessions

OTHER

Quality of Life Questionnaire Administration

Self-reported questionnaires are given to participants to complete

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Anand Dhruva, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2027-05-31

Completion

2027-12-31

Countries

• United States

Study Locations