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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
107
Given nutrition education
Given lifestyle recommendations
Participate in yoga
Participate in marma therapeutic touch
Attend online HEI sessions
Self-reported questionnaires are given to participants to complete
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Retention rates
The proportion of participants who complete \<=70% of study measures will be reported.
Time frame: 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
Time frame: 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.
Time frame: Up to 6 months
Assessment completion rates
Assessment completion rates will be defined as the percentage of participants completing each assessment.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Mean scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-C30)-Functional Domains over time
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
Time frame: Up to 6 months
Mean scores on the EORTC-C30 Global Health Status scale over time
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.
Time frame: Up to 6 months
Mean scores on the EORTC-C30 Breast Cancer (BR42) subscales scale over time
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.
Time frame: Up to 6 months
Mean scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue scale over time
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 6 months
Mean scores on the PROMIS Sleep Disturbance scale over time
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.
Time frame: Up to 6 months
Mean scores on the PROMIS Anxiety scale (Short Form) over time
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.
Time frame: Up to 6 months
Mean scores on the PROMIS Depressive symptoms scale over time
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.
Time frame: Up to 6 months
Mean scores on the PROMIS Pain scale over time
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.
Time frame: Up to 6 months
Mean scores on the PROMIS Self Efficacy over time
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.
Time frame: Up to 6 months
Mean scores on the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being measure (FACIT-SP-12) over time
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.
Time frame: Up to 6 months