Integrative Approaches to Cancer Survivorship: Project 3

NCT ID: NCT03479385

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2020-01-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Integrative Medicine Intervention

Study participants randomized to the Integrative Medicine intervention will attend 14 sessions with an Integrative Medicine clinician over the course of 6 months potentially followed by a 6 month maintenance phase. The treatment modalities employed in the study will include nutrition and lifestyle recommendations.

Group Type: EXPERIMENTAL

Integrative Medicine Intervention

Intervention Type: BEHAVIORAL

Study participants will attend 14 sessions with an Integrative Medicine clinician over the course of 6 months, potentially followed by a 6 month maintenance phase.

Health Education Intervention

Study participants randomized to the Health Education intervention will attend 14 sessions with a Health Educator over the course of 6 months. The emphasis in the sessions will be to provide engaging educational information on common survivorship issues.

Group Type: EXPERIMENTAL

Health Education Intervention

Intervention Type: BEHAVIORAL

Study participants will attend 14 sessions with a Health Educator over the course of 6 months.

Interventions

Integrative Medicine Intervention

Study participants will attend 14 sessions with an Integrative Medicine clinician over the course of 6 months, potentially followed by a 6 month maintenance phase.

Intervention Type: BEHAVIORAL

Health Education Intervention

Study participants will attend 14 sessions with a Health Educator over the course of 6 months.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anand Dhruva, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco, Osher Center for Integrative Medicine

San Francisco, California, United States

Countries

United States

Other Identifiers

16-185671

Identifier Type: -

Identifier Source: org_study_id