Trial Title:
Integrative Approaches for Cancer Survivorship (IACS3)
NCT ID:
NCT06633926
Condition:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Health Intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Participants will be masked to the study hypothesis. Research staff involved with data
analysis will be blinded to group assignment until the database is locked. The
statistician will remain blinded until the completion of the analysis.
Intervention:
Intervention type:
Behavioral
Intervention name:
Nutrition Education
Description:
Given nutrition education
Arm group label:
Ayurveda and Usual Care (AVI)
Intervention type:
Behavioral
Intervention name:
Lifestyle Counseling
Description:
Given lifestyle recommendations
Arm group label:
Ayurveda and Usual Care (AVI)
Intervention type:
Other
Intervention name:
Yoga
Description:
Participate in yoga
Arm group label:
Ayurveda and Usual Care (AVI)
Other name:
Yoga therapy
Intervention type:
Procedure
Intervention name:
Marma therapy
Description:
Participate in marma therapeutic touch
Arm group label:
Ayurveda and Usual Care (AVI)
Other name:
Marma therapeutic touch therapy
Other name:
Therapeutic touch therapy
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Attend online HEI sessions
Arm group label:
Health Education and Usual Care (HEI)
Other name:
Education for Intervention
Intervention type:
Other
Intervention name:
Quality of Life Questionnaire Administration
Description:
Self-reported questionnaires are given to participants to complete
Arm group label:
Ayurveda and Usual Care (AVI)
Arm group label:
Health Education and Usual Care (HEI)
Other name:
Quality of Life Survey
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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
Exclusion Criteria:
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. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zuckerberg San Francisco General
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Contact:
Phone:
415-476-1235
Email:
renewstudy@ucsf.edu
Investigator:
Last name:
Niharika Dixit, MD
Email:
Principal Investigator
Investigator:
Last name:
Maria Chao, DrPH, MPA
Email:
Principal Investigator
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Contact:
Last name:
Peea Kim
Phone:
415-476-1235
Email:
renewstudy@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Anand Dhruva, MD
Email:
Principal Investigator
Investigator:
Last name:
Frederick Hecht, MD
Email:
Sub-Investigator
Facility:
Name:
Kaiser Permanente Northwest (KPNW)
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Contact:
Phone:
503-335-5639
Email:
chr_renewstudy@kpchr.org
Facility:
Name:
Vanderbilt Ingram Cancer Center
Address:
City:
Nashville
Zip:
37212
Country:
United States
Investigator:
Last name:
Rajiv Agarwal, MD
Email:
Principal Investigator
Start date:
October 31, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
National Center for Complementary and Integrative Health (NCCIH)
Agency class:
NIH
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06633926
