Integrative health approaches for breast cancer survivors
Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study (Aim 2)
NA · University of California, San Francisco · NCT06633926
This study is testing two different health programs to see which one helps breast cancer survivors feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Trial ID | NCT06633926 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a pilot randomized controlled trial aimed at assessing the feasibility and acceptability of two integrative health approaches for non-metastatic breast cancer survivors. Participants will be randomized into two groups: one receiving Ayurveda-based interventions including nutrition education, lifestyle practices, yoga, and marma therapeutic touch, and the other receiving self-directed health education through online content. The study focuses on evaluating quality of life and cancer-associated symptoms rather than testing efficacy. A total of 104 participants will be involved across multiple sites.
Who should consider this trial
Good fit: Ideal candidates are non-metastatic breast cancer survivors aged 18 and older who are within 1 to 36 months post-treatment and report impaired quality of life.
Not a fit: Patients with metastatic breast cancer or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for breast cancer survivors through integrative health approaches.
How similar studies have performed: Other studies have shown promise in using integrative health approaches for cancer survivorship, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
San Francisco, California and 3 other locations
- Zuckerberg San Francisco General — San Francisco, California, United States (RECRUITING)
- University of California, San Francisco — San Francisco, California, United States (RECRUITING)
- Kaiser Permanente Northwest (KPNW) — San Francisco, California, United States (NOT_YET_RECRUITING)
- Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Anand Dhruva, MD — University of California, San Francisco
- Study coordinator: Patricia Moran, PhD
- Email: renewstudy@ucsf.edu
- Phone: 415-476-1235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Health Intervention