Integrative Approaches for Cancer Survivorship (IACS3)

NCT06633926 | Active Not Recruiting DMC

• 3 other identifiers: 24807NCI-2024-07529R01AT012522
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8

Keywords

Health Intervention

Outcome Measures

Primary Outcomes (10)

• Proportion of all screened participants who were ultimately enrolled

  The proportion of all screened participants who were ultimately enrolled onto the study will be reported.

  Up to 15 months

• Proportion of eligible screens who decline to enroll

  Proportion of eligible screens who decline to enroll due to concerns about randomization will be reported.

  Up to 15 months

• Proportion of enrolled participants who drop out immediately after assignment

  Proportion of enrolled participants who drop out after learning their randomization assignment will be reported.

  Up to 15 months

• Proportion of randomized participants who drop out during participation

  Proportion of randomized participants who drop out after participating in the study interventions due to unhappiness with randomization assignment will be reported.

  Up to 6 months

• Retention rates

  The proportion of participants who complete \<=70% of study measures will be reported.

  Up to 6 months

• Adherence to intervention rate

  Proportion of participants who attended at least 10 out of 14 sessions or completed 10 out of 14 HEI sessions (≥80%) will be reported

  Up to 6 months

• Practitioner fidelity rates

  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.

  Up to 6 months

• Assessment completion rates

  Assessment completion rates will be defined as the percentage of participants completing each assessment.

  Up to 6 months

• Mean scores on an Acceptability of Intervention measure

  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.

  Up to 6 months

• Change in mean scores on an Expectation of Benefit questionnaire over time

  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.

  Up to 6 months

Secondary Outcomes (10)

• Mean scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-C30)-Functional Domains over time

  Up to 6 months

• Mean scores on the EORTC-C30 Global Health Status scale over time

  Up to 6 months

• Mean scores on the EORTC-C30 Breast Cancer (BR42) subscales scale over time

  Up to 6 months

• Mean scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue scale over time

  Up to 6 months

• Mean scores on the PROMIS Sleep Disturbance scale over time

  Up to 6 months

Study Arms (2)

Ayurveda and Usual Care (AVI)

EXPERIMENTAL

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.

Behavioral: Nutrition Education; Behavioral: Lifestyle Counseling; Other: Yoga; Procedure: Marma therapy; Other: Quality of Life Questionnaire Administration

Health Education and Usual Care (HEI)

EXPERIMENTAL

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.

Other: Educational Intervention; Other: Quality of Life Questionnaire Administration

Interventions

Nutrition Education BEHAVIORAL

Given nutrition education

Ayurveda and Usual Care (AVI)

Lifestyle Counseling BEHAVIORAL

Given lifestyle recommendations

Ayurveda and Usual Care (AVI)

Yoga OTHER

Participate in yoga

Also known as: Yoga therapy

Ayurveda and Usual Care (AVI)

Marma therapy PROCEDURE

Participate in marma therapeutic touch

Also known as: Marma therapeutic touch therapy, Therapeutic touch therapy

Ayurveda and Usual Care (AVI)

Educational Intervention OTHER

Attend online HEI sessions

Also known as: Education for Intervention

Health Education and Usual Care (HEI)

Quality of Life Questionnaire Administration OTHER

Self-reported questionnaires are given to participants to complete

Also known as: Quality of Life Survey

Ayurveda and Usual Care (AVI); Health Education and Usual Care (HEI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients
• 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.
• Ayurveda Practitioners
• \. None

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (4)

Zuckerberg San Francisco General

San Francisco, California, 94115, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Kaiser Permanente Northwest (KPNW)

San Francisco, California, 94158, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Interventions

Nutrition Assessment; Yoga; Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Anand Dhruva, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to the study hypothesis. Research staff involved with data analysis will be blinded to group assignment until the database is locked. The statistician will remain blinded until the completion of the analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (4)