Integrative Approaches For Cancer Survivorship 2: Project 1

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Individualized Integrative Medicine Intervention

• Registration Number: NCT02897635
• Lead Sponsor: University of California, San Francisco

Brief Summary

The purpose of this study is to develop and test a 12-month Integrative Medicine intervention based on Ayurvedic medicine in recent breast cancer survivors.

Detailed Description

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. The investigators aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to refine the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Primary Completion: 2018-09-21
• Study Completion: 2018-09-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrative Medicine Intervention	Individualized Integrative Medicine Intervention	Study participants will attend 14 visits with an integrative medicine clinician over the course of 6 months followed by a 6 month maintenance phase. The treatment modalities employed in the study will include nutrition and lifestyle recommendations.

Primary Outcome Measures

Name	Time	Method
Change in quality of life over 12 months	Baseline, 3 months, 6 months, 12 months	The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a Breast Cancer-Specific Subscale (BR23) to collect data on qualify of life and cancer-related symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in fatigue over 12 months	Baseline, 3 months, 6 months, 12 months	The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
Change in depressive symptoms over 12 months	Baseline, 3 months, 6 months, 12 months	The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.
Change in sleep quality over 12 months	Baseline, 3 months, 6 months, 12 months	The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
Change in anxiety over 12 months	Baseline, 3 months, 6 months, 12 months	The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.
Change in pain over 12 months	Baseline, 3 months, 6 months, 12 months	The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.
Change in diet over 12 months	Baseline, 3 months, 6 months, 12 months	The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.

Trial Locations

Locations (1)

University of California, San Francisco, Osher Center for Integrative Medicine; 🇺🇸 San Francisco, California, United States