AzTrials
AzTrials

Anatomic Stage I Breast Cancer AJCC v8NCT06633926

Integrative Approaches for Cancer Survivorship (IACS3)

A study testing Nutrition Education, Lifestyle Counseling and Yoga in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of California, San Francisco at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nutrition Education, Lifestyle Counseling and Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
4 sitesUnited States
Study dates
31 Mar 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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
  • 1. Must be engaged as an Ayurvedic Intervention practitioner on the Renew study

Who cannot join

  • 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.
Show all 11Show fewer
  • 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
  • 1. None

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37212

  • Zuckerberg San Francisco General

    San Francisco, California, 94115

  • University of California, San Francisco

    San Francisco, California, 94143

  • Kaiser Permanente Northwest (KPNW)

    San Francisco, California, 94158

Other trials in United States

About this study

Official title: Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study (Aim 2)

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.

Read the detailed description

PRIMARY OBJECTIVES

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

SECONDARY OBJECTIVES

  1. 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.

Being tested
Nutrition Education, Lifestyle Counseling, Yoga, Marma therapy, Educational Intervention
Keywords
Health Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition EducationBehavioural

    Given nutrition education

  • Lifestyle CounselingBehavioural

    Given lifestyle recommendations

  • YogaOther

    Also called Yoga therapy

    Participate in yoga

  • Marma therapyProcedure or surgery

    Also called Marma therapeutic touch therapy, Therapeutic touch therapy

    Participate in marma therapeutic touch

  • Educational InterventionOther

    Also called Education for Intervention

    Attend online HEI sessions

  • Quality of Life Questionnaire AdministrationOther

    Also called Quality of Life Survey

    Self-reported questionnaires are given to participants to complete

Study groups in NCT06633926
Study groupRoleWhat they receive
Ayurveda and Usual Care (AVI)ExperimentalParticipants 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.
Receives: Behavioral: Nutrition Education; Behavioral: Lifestyle Counseling; Other: Yoga; Procedure: Marma therapy; Other: Quality of Life Questionnaire Administration
Health Education and Usual Care (HEI)ExperimentalParticipants 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.
Receives: Other: Educational Intervention; Other: Quality of Life Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 15 months

  2. Proportion of eligible screens who decline to enroll

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

    Measured: Up to 15 months

  3. 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.

    Measured: Up to 15 months

  4. 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.

    Measured: Up to 6 months

  5. Retention rates

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

    Measured: Up to 6 months

  6. 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

    Measured: Up to 6 months

  7. 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.

    Measured: Up to 6 months

  8. Assessment completion rates

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

    Measured: Up to 6 months

  9. 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.

    Measured: Up to 6 months

  10. 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.

    Measured: Up to 6 months

Secondary outcomes (10)

  1. 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

    Measured: Up to 6 months

  2. 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.

    Measured: Up to 6 months

  3. 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.

    Measured: Up to 6 months

  4. 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.

    Measured: Up to 6 months

  5. 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.

    Measured: Up to 6 months

  6. 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.

    Measured: Up to 6 months

  7. 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.

    Measured: Up to 6 months

  8. 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.

    Measured: Up to 6 months

  9. 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.

    Measured: Up to 6 months

  10. 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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start31 Mar 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06633926
Sponsor's protocol ID
24807
Other IDs
NCI-2024-07529, R01AT012522
Status last verified
Jul 2026
First submitted
7 Oct 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: de-identified data will be shared with research collaborators

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition Education, Lifestyle Counseling and Yoga in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of California, San Francisco at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of all screened participants who were ultimately enrolled (time frame: Up to 15 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06633926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in