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Completed

NCT Number: NCT02897635

Integrative Approaches For Cancer Survivorship 2: Project 1

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

San Francisco, California, 94115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized Integrative Medicine Intervention

Behavioral

Primary outcomes

  1. Change in quality of life over 12 months

    Time frame: 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 outcomes

  1. Change in fatigue over 12 months

    Time frame: Baseline, 3 months, 6 months, 12 months

    The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.

  2. Change in sleep quality over 12 months

    Time frame: Baseline, 3 months, 6 months, 12 months

    The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.

  3. Change in anxiety over 12 months

    Time frame: Baseline, 3 months, 6 months, 12 months

    The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.

  4. Change in depressive symptoms over 12 months

    Time frame: 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.

  5. Change in pain over 12 months

    Time frame: 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.

  6. Change in diet over 12 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship

Acronym: IACS2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2016
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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