NCT06633926

Integrative Approaches for Cancer Survivorship (IACS3)

Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study (Aim 2)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES I. Determine feasibility and acceptability of this design in a multi-site setting. SECONDARY OBJECTIVES I. Evaluate Quality of Life (QOL). II. Evaluate Cancer Associated Symptoms. OUTLINE: Participants are randomized in a 1:1 ratio to 1 of 2 arms. ARM I: Participants receive usual care on study. Participants also receive nutrition education, lifestyle recommendations, and participate in yoga, as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months. After 6 months, participants may also complete a videoconference visit over 30 minutes once monthly for 6 months. ARM II: Participants receive usual care on study. Participants also access self-directed online HEI sessions over 1 hour each for up to 15 sessions over 6 months.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-31
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2024-10-09
• Last updated: 2026-02-13

Locations

4 sites across 1 country: United States