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Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study (Aim 2)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients

• Age \>= 18

• Able to understand study procedures and to comply with them for the entire length of the study.

• Able to read, write, and understand English.

• Ability of individual or legal guardian/representative to understand a verbal informed consent document, and the willingness to sign it.

• 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.

• Participants should have received chemotherapy as part of their primary treatment.

• 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?

• Karnofsky Performance Status Score (KPS) \>=60

⁃ Ayurveda Practitioners

⁃ 1\. Must be engaged as an Ayurvedic Intervention practitioner on the Renew study

Locations
United States
California
Kaiser Permanente Northwest (KPNW)
RECRUITING
San Francisco
University of California, San Francisco
RECRUITING
San Francisco
Zuckerberg San Francisco General
RECRUITING
San Francisco
Tennessee
Vanderbilt Ingram Cancer Center
NOT_YET_RECRUITING
Nashville
Contact Information
Primary
Patricia Moran, PhD
renewstudy@ucsf.edu
415-476-1235
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 108
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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