Integrative Approaches for Cancer Survivorship (IACS3)

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Oct 7, 2024

Keywords

ClinConnect Summary

The Integrative Approaches for Cancer Survivorship (IACS3) clinical trial is studying two different health programs designed for people who have survived non-metastatic breast cancer. The goal is to see how well these programs work together and if participants find them helpful. There are two options for participants: one group will receive a program that combines nutrition, yoga, and a special touch therapy called marma, while the other group will access educational materials about health and wellness online. This trial is focused on understanding if these approaches are practical and acceptable for survivors, rather than testing if they are effective.

To participate in the trial, you need to be at least 18 years old and have completed your main cancer treatments within the last 1 to 36 months. You should also be in complete remission and have had chemotherapy as part of your treatment. Additionally, you should be able to understand and follow the study’s instructions, and your quality of life should be rated as low on a specific questionnaire. While the trial is currently recruiting, it’s important to know that some individuals, such as those with severe anxiety or depression, or those who have recently had surgery, may not be eligible. Participants can expect to engage in one of the two programs and share their experiences throughout the study.

Gender

ALL

Eligibility 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.