RECRUITING

Integrative Approaches for Cancer Survivorship (IACS3)

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Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Health Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-03-31
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06633926

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>= 18
  2. 2. Able to understand study procedures and to comply with them for the entire length of the study.
  3. 3. Able to read, write, and understand English.
  4. 4. Ability of individual or legal guardian/representative to understand a verbal informed consent document, and the willingness to sign it.
  5. 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. 6. Participants should have received chemotherapy as part of their primary treatment.
  7. 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. 8. Karnofsky Performance Status Score (KPS) \>=60
  1. 1. Contraindication to any study-related procedure or assessment.
  2. 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. 3. Participants are within 1 month after surgery for cancer, including breast reconstructive surgery but not including implant exchange.
  4. 4. Cancer surgery planned during the initial 6-month study period.
  5. 5. Been on adjuvant hormone therapy (for breast cancer) less than 2 months at the time of enrollment.
  6. 6. Received Ayurvedic treatment during the 3 months preceding enrollment.
  7. 7. Severe depression assessed by the Patient Health Questionnaire Depression scale (PHQ-8) using a cutoff score of 20 or higher or severe anxiety assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7) using a cutoff score of 15 or higher.

Contacts and Locations

Study Contact

Patricia Moran, PhD
CONTACT
415-476-1235
renewstudy@ucsf.edu

Principal Investigator

Anand Dhruva, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Health Intervention

Additional Relevant MeSH Terms

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