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Integrative Approaches for Cancer Survivorship 3
Trial Status: active
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. Health Education Intervention (HEI) 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.
Inclusion Criteria
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 an 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
Patients 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 Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ C30]. “How would you rate your overall quality of life during the past week?” [Answers range from 1 – very poor to 7 – excellent])
Performance status score (Karnofsky performance status [KPS]) ≥ 60
Exclusion Criteria
Contraindication to any study-related procedure or assessment
Metastatic disease and receiving chemotherapy or radiotherapy at the time of study enrollment (patients with non-metastatic disease who are receiving anti-Her2 directed treatment alone in the adjuvant setting are eligible)
Patients are within 1 month after surgery for cancer, including breast reconstructive surgery but not including implant exchange
Cancer surgery planned during the initial 6-month study period
Been on adjuvant hormone therapy (for breast cancer) less than 2 months at the time of enrollment
Received Ayurvedic treatment during the 3 months preceding enrollment
If a participant reports severe anxiety or depression, has severe depression assessed by Patient Health Questionnaire (PHQ)-9 using a cutoff of 20 or higher, or severe anxiety assessed by the General Anxiety Disorder (GAD)-7 using a cut off 15 or higher
Current suicidal ideation (PHQ9 item 9 > 0 and Columbia-Suicide Severity Rating Scale [C-SSRS] response > low risk)
Additional locations may be listed on ClinicalTrials.gov for NCT06633926.
I. To determine the feasibility, acceptability, and fidelity of the integrative medicine survivorship interventions (Ayurveda and Facing Forward Health Education) and study design in a multi-site setting.
SECONDARY OBJECTIVE:
I. Evaluate the promise of clinical benefit in terms of changes (within group) in quality of life, cancer-related symptoms, and qualitative interviews.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual care on study. Patients 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, patients may also complete a videoconference visit over 30 minutes once monthly for 6 months and complete additional questionnaires at 12 months.
ARM II: Patients receive usual care on study. Patients also access self-directed online HEI sessions over 1 hour each for up to 15 sessions over 6 months. After 6 months, some patients will also complete additional questionnaires at 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of California San Francisco
