Integrative Approaches for Breast Cancer Survivorship
This study, called IACS3, is for people who have completed treatment for early-stage breast cancer (Anatomic Stage I, II, or III). It's looking at two different approaches to help survivors: one is called Ayurveda Intervention (AVI) and the other is Facing Forward Health Education Intervention (FFHEI). AVI involves nutrition education, lifestyle tips, yoga, and a type of therapeutic touch called marma therapy. FFHEI uses online videos and materials to provide health education. The main goal is to see if these programs are practical and acceptable for people to use, and if the study design works well across different locations. You must be at least 18 years old and able to understand English to participate.
- Study design
- This is a pilot randomized controlled trial with 106 participants. You would be randomly assigned to one of two groups: either the Ayurveda Intervention or the Facing Forward Health Education Intervention.
- What's involved
- If in the AVI group, you would have up to 14 one-on-one visits over 6 months, plus optional monthly videoconference visits for another 6 months. If in the FFHEI group, you would access up to 15 online sessions over 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track certain information, like enrollment and dropout rates, for up to 15 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Integrative Approaches for Cancer Survivorship (IACS3)
At a glance
Conditions
Where it's being run
4 sites across 2 statesStudy leadership
- Anand Dhruva, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Proportion of all screened participants who were ultimately enrolledUp to 15 months
The proportion of all screened participants who were ultimately enrolled onto the study will be reported.
- Proportion of eligible screens who decline to enrollUp to 15 months
Proportion of eligible screens who decline to enroll due to concerns about randomization will be reported.
- Proportion of enrolled participants who drop out immediately after assignmentUp to 15 months
Proportion of enrolled participants who drop out after learning their randomization assignment will be reported.
- Proportion of randomized participants who drop out during participationUp to 6 months
Proportion of randomized participants who drop out after participating in the study interventions due to unhappiness with randomization assignment will be reported.
- Retention ratesUp to 6 months
The proportion of participants who complete \<=70% of study measures will be reported.
- Adherence to intervention rateUp to 6 months
Proportion of participants who attended at least 10 out of 14 sessions or completed 10 out of 14 HEI sessions (≥80%) will be reported
- Practitioner fidelity ratesUp to 6 months
Fidelity of adherence to the intervention will be assessed through a contact check-list method comparing the intervention to the study manuals and the rate of adherence will be reported.
- Assessment completion ratesUp to 6 months
Assessment completion rates will be defined as the percentage of participants completing each assessment.
- Mean scores on an Acceptability of Intervention measureUp to 6 months
The measure used for this study is a single item assessment of the implementation to participants perceived acceptability of the intervention. The response item response falls on a numeric rating scale of 0 to 10. A mean score is calculated by averaging responses from all participants. The intervention will be determined acceptable if the overall mean score is \>= 8.
- Change in mean scores on an Expectation of Benefit questionnaire over timeUp to 6 months
The change in participant's expectation of intervention benefit at baseline-pre and post randomization-will be assessed using a 0-10 numeric rating scale of 0 to 10. A mean score is calculated by averaging responses from all participants. The instrument for expectancy, is adapted from a measure created by Kalauokalani et. al, with higher scores indicating a higher level of expectation that the intervention will be beneficial.