Clinical trial NCT03479385: Integrative Approaches to Cancer Survivorship: Project 3
Official title: Developing an Integrative Intervention for Breast Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to conduct a randomized controlled trial or RCT of the following 2 supportive care interventions in recent breast cancer survivors: an Integrative Medicine intervention based on Ayurvedic medicine and a Health Education intervention.

Detailed description: Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. In addition, cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. In the Integrative Medicine intervention, Ayurvedic nutrition and lifestyle guidance will be presented, along with instruction in Yoga. In the Health Education intervention, informative content on issues relevant to breast cancer survivors will be presented including the physical, social and emotional impacts of survivorship. The investigators aim to perform a pilot RCT in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to assess feasibility of randomization, adherence and retention to the Integrative Medicine and Health Education interventions.

Eligibility criteria: Inclusion Criteria:

* Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
* Having received chemotherapy as part of their primary therapy for breast cancer
* Be in complete remission
* Aged 18 years or older
* Able to read, write, and understand English
* Karnofsky Performance Status (KPS) greater than or equal to 60
* Have impaired quality of life
* Ability to give informed consent

Exclusion Criteria:

* Having received Ayurvedic treatment within 6 months of study enrollment
* Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
* Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
* Patients on adjuvant hormone therapy for less than 2 months
* Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.

Primary outcomes:
measure: Change in quality of life over 6 months
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in fatigue over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in sleep quality over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in anxiety over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in depressive symptoms over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in pain over 6 months
timeFrame: Baseline, 3 months, 6 months
measure: Change in diet over 6 months
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anand Dhruva, MD
role: PRINCIPAL_INVESTIGATOR
References: