Clinical trial NCT06633926: Integrative Approaches for Cancer Survivorship (IACS3)
Official title: Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study (Aim 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Keywords: Health Intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-10-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of all screened participants who were ultimately enrolled
timeFrame: Up to 15 months
measure: Proportion of eligible screens who decline to enroll
timeFrame: Up to 15 months
measure: Proportion of enrolled participants who drop out immediately after assignment
timeFrame: Up to 15 months
measure: Proportion of randomized participants who drop out during participation
timeFrame: Up to 6 months
measure: Retention rates
timeFrame: Up to 6 months
measure: Adherence to intervention rate
timeFrame: Up to 6 months
measure: Practitioner fidelity rates
timeFrame: Up to 6 months
measure: Assessment completion rates
timeFrame: Up to 6 months
measure: Mean scores on an Acceptability of Intervention measure
timeFrame: Up to 6 months
measure: Change in mean scores on an Expectation of Benefit questionnaire over time
timeFrame: Up to 6 months
Secondary outcomes:
measure: Mean scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-C30)-Functional Domains over time
timeFrame: Up to 6 months
measure: Mean scores on the EORTC-C30 Global Health Status scale over time
timeFrame: Up to 6 months
measure: Mean scores on the EORTC-C30 Breast Cancer (BR42) subscales scale over time
timeFrame: Up to 6 months
measure: Mean scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue scale over time
timeFrame: Up to 6 months
measure: Mean scores on the PROMIS Sleep Disturbance scale over time
timeFrame: Up to 6 months
measure: Mean scores on the PROMIS Anxiety scale (Short Form) over time
timeFrame: Up to 6 months
measure: Mean scores on the PROMIS Depressive symptoms scale over time
timeFrame: Up to 6 months
measure: Mean scores on the PROMIS Pain scale over time
timeFrame: Up to 6 months
measure: Mean scores on the PROMIS Self Efficacy over time
timeFrame: Up to 6 months
measure: Mean scores on the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being measure (FACIT-SP-12) over time
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northwest (KPNW)
state: California
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: University of California, San Francisco
name: Anand Dhruva, MD
role: PRINCIPAL_INVESTIGATOR
References: