Integrative Approaches for Cancer Survivorship (IACS3) (NCT06633926) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Integrative Approaches for Cancer Survivorship (IACS3)
United States106 participantsStarted 2025-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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?"
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of all screened participants who were ultimately enrolled
Timeframe: Up to 15 months
2
Proportion of eligible screens who decline to enroll
Timeframe: Up to 15 months
3
Proportion of enrolled participants who drop out immediately after assignment
Timeframe: Up to 15 months
4
Proportion of randomized participants who drop out during participation
. Contraindication to any study-related procedure or assessment.
. 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).
. Participants 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 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.
. Current suicidal ideation.
Assessment completion rates
Timeframe: Up to 6 months
9
Mean scores on an Acceptability of Intervention measure
Timeframe: Up to 6 months
10
Change in mean scores on an Expectation of Benefit questionnaire over time