Integrative Approaches for Cancer Survivorship (IACS3)

Not Applicable

Recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8
• Interventions: Behavioral: Nutrition Education; Other: Educational Intervention; Behavioral: Lifestyle Counseling; Other: Yoga; Procedure: Marma therapy; Other: Quality of Life Questionnaire Administration

• Registration Number: NCT06633926
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

PRIMARY OBJECTIVES

I. Determine feasibility and acceptability of this design in a multi-site setting.

SECONDARY OBJECTIVES

I. Evaluate Quality of Life (QOL).

II. Evaluate Cancer Associated Symptoms.

OUTLINE: Participants are randomized in a 1:1 ratio to 1 of 2 arms.

ARM I: 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.

ARM II: Participants receive usual care on study. Participants also access self-directed online HEI sessions over 1 hour each for up to 15 sessions over 6 months.

Study Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Study Start: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ayurveda and Usual Care (AVI)	Yoga	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.
Ayurveda and Usual Care (AVI)	Nutrition Education	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.
Ayurveda and Usual Care (AVI)	Lifestyle Counseling	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.
Ayurveda and Usual Care (AVI)	Marma therapy	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.
Ayurveda and Usual Care (AVI)	Quality of Life Questionnaire Administration	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.
Health Education and Usual Care (HEI)	Educational Intervention	Participants receive usual care on study. Participants also attend online HEI sessions over 1 hour each for up to 15 sessions over 6 months.
Health Education and Usual Care (HEI)	Quality of Life Questionnaire Administration	Participants receive usual care on study. Participants also attend online HEI sessions over 1 hour each for up to 15 sessions over 6 months.

Primary Outcome Measures

Name	Time	Method
Proportion of all screened participants who were ultimately enrolled	Up 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 enroll	Up 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 assignment	Up 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 participation	Up 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 rates	Up to 6 months	The proportion of participants who complete \<=70% of study measures will be reported.
Adherence to intervention rate	Up 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 rates	Up 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 rates	Up to 6 months	Assessment completion rates will be defined as the percentage of participants completing each assessment.
Mean scores on an Acceptability of Intervention measure	Up 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 time	Up 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.

Secondary Outcome Measures

Name	Time	Method
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	The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning
Mean scores on the PROMIS Self Efficacy over time	Up to 6 months	This 4-item questionnaire to measure the extent to which persons with chronic conditions are able to managing daily activities, medications and treatments, symptoms, emotions, and social interactions based on responses to statements about how the participants feel with a with a response ranging from 1="I am not at all confident" to 5="I am very confident", and a total raw score ranging from 4 - 20, which are then converted to a scaled T-score (range 18.6 to 64.7) with higher scores indicating a greater feeling of self-efficacy in managing daily activities.
Mean scores on the EORTC-C30 Global Health Status scale over time	Up to 6 months	The global health status score consists of responses to two items with responses ranging from 1="very poor" to 4="excellent". The raw score is calculated by estimating the mean of the two items that make up the global health scale with a resulting total range of 1-7. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the global health status represents a higher quality of life.
Mean scores on the EORTC-C30 Breast Cancer (BR42) subscales scale over time	Up to 6 months	The breast cancer module of the EORTC-C30 (BR42) status score consists of responses to 42 items divided into 10 scales: Breast Symptoms, Body Image, Sexual Functioning, Arm Symptoms, Systemic Chemotherapy Side Effects, Hand/Feet Symptoms/Neuropathy, Skeletal Symptoms, Endocrine Symptoms, Breast Satisfaction, Vaginal Symptoms, and 3 single items: Weight Gain, Sexual Enjoyment and Future Perspective with responses ranging from 1="very poor" to 4="excellent". The raw score is calculated by estimating the mean of the items that make up the scales with a resulting total range of 1-168. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score represents a higher quality of life.
Mean scores on the PROMIS Depressive symptoms scale over time	Up to 6 months	The PROMIS Depression Short form consists of 4 items addressing patient depression with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of depression.
Mean scores on the PROMIS Pain scale over time	Up to 6 months	This 4-item questionnaire to measure the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities based on responses to statements about how the participants feel with a with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 4 - 20, which are converted to a scaled T-score (range 41.6 to 75.6) with higher scores indicating a greater hinderance to engagement in activities based on how much pain participants are experiencing.
Mean scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue scale over time	Up to 6 months	This 6-item questionnaire to measure fatigue based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 6 - 30, which are converted to a scaled T-score (range 33.4 to 76.8) with higher scores indicating a greater feeling of fatigue.
Mean scores on the PROMIS Sleep Disturbance scale over time	Up to 6 months	This 6-item questionnaire to measure sleep disturbance based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 6 - 30, which are converted to a scaled T-score (range 31.7 to 73.3) with higher scores indicating a greater feeling of sleep disturbance.
Mean scores on the PROMIS Anxiety scale (Short Form) over time	Up to 6 months	The PROMIS Anxiety Short form consists of 2 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety.
Mean scores on the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being measure (FACIT-SP-12) over time	Up to 6 months	The FACIT-SP-12 is a 12-item questionnaire which measures a participant's spiritual well-being for the past 7 days. Item responses range from 0 (not at all) to 4 (very much). The sum of item scores is used to calculate a total FACIT-SP-12 score ranging from 0 to 48. The higher the score, the better the QOL/spiritual well-being.

Trial Locations

Locations (4)

Zuckerberg San Francisco General; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Kaiser Permanente Northwest (KPNW); 🇺🇸 San Francisco, California, United States

Vanderbilt Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States