Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2025-03-31
2027-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Ayurveda and Usual Care (AVI)
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. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
Nutrition Education
Given nutrition education
Lifestyle Counseling
Given lifestyle recommendations
Yoga
Participate in yoga
Marma therapy
Participate in marma therapeutic touch
Quality of Life Questionnaire Administration
Self-reported questionnaires are given to participants to complete
Health Education and Usual Care (HEI)
Participants receive usual care on study. Participants also attend online HEI sessions over 1 hour each for up to 15 sessions over 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.
Educational Intervention
Attend online HEI sessions
Quality of Life Questionnaire Administration
Self-reported questionnaires are given to participants to complete
Interventions
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Nutrition Education
Given nutrition education
Lifestyle Counseling
Given lifestyle recommendations
Yoga
Participate in yoga
Marma therapy
Participate in marma therapeutic touch
Educational Intervention
Attend online HEI sessions
Quality of Life Questionnaire Administration
Self-reported questionnaires are given to participants to complete
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Anand Dhruva, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Zuckerberg San Francisco General
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Kaiser Permanente Northwest (KPNW)
San Francisco, California, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: backup
Role: primary
Other Identifiers
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NCI-2024-07529
Identifier Type: REGISTRY
Identifier Source: secondary_id
24807
Identifier Type: -
Identifier Source: org_study_id
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