Integrative Health Approaches for Breast Cancer Survivors

Recruiting at 3 trial locations

Overseen By Patricia Moran, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Metastatic disease, Recent surgery, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 6 months

104 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants with non-metastatic disease receiving anti-Her2 treatment are eligible, suggesting some treatments may be continued. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Ayurveda Intervention (AVI) and Facing Forward Health Education Intervention (FFHEI) for breast cancer survivors?

A study found that a 4-month Ayurvedic nutrition and lifestyle program was feasible and acceptable for breast cancer survivors, suggesting it might help improve their quality of life. ^{1 2 3 4 5}

Is the Ayurvedic Intervention safe for breast cancer survivors?

A 4-month Ayurvedic nutrition and lifestyle intervention was found to be feasible and acceptable for breast cancer survivors, suggesting it is generally safe for this group. ^{1 2 3 4 6}

How does the Integrative Health Approaches treatment for breast cancer survivors differ from other treatments?

This treatment is unique because it combines Ayurvedic medicine, which focuses on nutrition and lifestyle changes, with a health education intervention, offering a holistic approach to improve quality of life for breast cancer survivors, unlike conventional treatments that primarily focus on medical interventions. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Anand Dhruva, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for non-metastatic breast cancer survivors. It's designed to see if two different health approaches are practical and well-received in a multi-site setting. Participants must be past the initial treatment phase of their cancer.

Inclusion Criteria

Able to read, write, and understand English

I have received chemotherapy as part of my initial cancer treatment.

I understand and can follow the study's procedures.

Exclusion Criteria

I had cancer surgery, including breast reconstruction, within the last month.

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

I am scheduled for cancer surgery within the next 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Ayurveda Intervention (AVI) or Facing Forward Health Education Intervention (FFHEI) over 6 months. AVI includes nutrition education, lifestyle practices, yoga, and marma therapeutic touch. FFHEI involves self-directed online health education sessions.

6 months

Up to 14 in-person visits for AVI, up to 15 online sessions for FFHEI

Follow-up

Participants are monitored for safety and effectiveness after treatment. AVI participants may have monthly videoconference visits for 6 months.

6 months

6 monthly videoconference visits for AVI

Treatment Details

Interventions

• Ayurveda Intervention (AVI)
• Facing Forward Health Education Intervention (FFHEI)

Trial Overview The study compares two integrative health interventions: Ayurveda Intervention (AVI) which includes nutrition, yoga, lifestyle counseling, and marma therapy; versus Facing Forward Health Education Intervention (FFHEI), which offers online educational content on survivorship.

Participant Groups

Group I: Health Education and Usual Care (HEI) Experimental Treatment 2 Interventions

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.

Group II: Ayurveda and Usual Care (AVI) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A 4-Month Whole-Systems Ayurvedic Medicine Nutrition and Lifestyle Intervention Is Feasible and Acceptable for Breast Cancer Survivors: Results of a Single-Arm Pilot Clinical Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of complementary/alternative medicine by breast cancer survivors in Ontario: prevalence and perceptions. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Correlates of use of different types of complementary and alternative medicine by breast cancer survivors in the nurses' health study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapies among very long-term breast cancer survivors. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Use of non-conventional medicine and lifestyle change among cancer survivors: evidence from the national VICAN survey. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Complementary medicine use before and 1 year following genetic testing for BRCA1/2 mutations. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Surviving breast cancer: the role of complementary therapies. [2019]