This study is in progress, not accepting new patients

Integrative Approaches for Cancer Survivorship (IACS3)

a study on Breast Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Anand Dhruva (ucsf)
Headshot of Anand Dhruva
Anand Dhruva

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVES

  1. Determine feasibility and acceptability of this design in a multi-site setting.

SECONDARY OBJECTIVES

  1. 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.

Keywords

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Health Intervention, Nutrition Assessment, Yoga, Educational Early Intervention, Educational Status, Methods, Nutrition Education, Marma therapy, Educational Intervention

Eligibility

You can join if…

Open to people ages 18 years and up

Patients

  1. Age >= 18
  2. Able to understand study procedures and to comply with them for the entire length of the study.
  3. Able to read, write, and understand English.
  4. Ability of individual or legal guardian/representative to understand a verbal informed consent document, and the willingness to sign it.
  5. Non-metastatic breast cancer patients who are between 1 and 36 months after completion of primary treatment (i.e., surgery, radiotherapy, chemotherapy) and are in a complete remission.
  6. Participants should have received chemotherapy as part of their primary treatment.
  7. Have an impaired quality of life (report a score of 5 or less on question 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Cancer questionnaire (EORTC-QLQ-C30). "How would you rate your overall quality of life during the past week?"
  8. Karnofsky Performance Status Score (KPS) >=60

Ayurveda Practitioners

  1. Must be engaged as an Ayurvedic Intervention practitioner on the Renew study

You CAN'T join if...

Patients

  1. Contraindication to any study-related procedure or assessment.
  2. Metastatic disease and receiving chemotherapy or radiotherapy at the time of study enrollment (participants with non-metastatic disease who are receiving anti-Her2 directed treatment alone in the adjuvant setting are eligible).
  3. Participants are within 1 month after surgery for cancer, including breast reconstructive surgery but not including implant exchange.
  4. Cancer surgery planned during the initial 6-month study period.
  5. Been on adjuvant hormone therapy (for breast cancer) less than 2 months at the time of enrollment.
  6. Received Ayurvedic treatment during the 3 months preceding enrollment.
  7. If a participant reports severe anxiety or depression, has severe depression assessed by Patient Health Questionnaire (PHQ)-9 using a cut-off of 20 or higher, or severe anxiety assessed by the General Anxiety Disorder-7 (GAD-7) using a cut-off 15 or higher.
  8. Current suicidal ideation.

Ayurveda Practitioners

  1. None

Locations

  • Zuckerberg San Francisco General
    San Francisco California 94115 United States
  • University of California, San Francisco
    San Francisco California 94143 United States
  • Kaiser Permanente Northwest (KPNW)
    San Francisco California 94158 United States
  • Vanderbilt Ingram Cancer Center
    Nashville Tennessee 37212 United States

Lead Scientist at University of California Health

  • Anand Dhruva (ucsf)
    My work focuses on the study and clinical application of non-pharmacologic integrative medicine approaches for cancer supportive and palliative care. These include diet and lifestyle practices from Ayurvedic Medicine (a traditional medicine from South Asia), as well as Yoga, meditation, and natural products.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06633926
Study Type
Interventional
Participants
About 106 people participating
Last Updated