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Integrative Approaches For Cancer Survivorship 2: Project 1 (IACS2)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized Integrative Medicine Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrative Medicine Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in quality of life over 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

Change in fatigue over 12 months
The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
Change in sleep quality over 12 months
The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
Change in anxiety over 12 months
The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.
Change in depressive symptoms over 12 months
The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.
Change in pain over 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
The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.

Full Information

First Posted
September 7, 2016
Last Updated
March 1, 2019
Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02897635
Brief Title
Integrative Approaches For Cancer Survivorship 2: Project 1
Acronym
IACS2
Official Title
Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
September 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrative Medicine Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Integrative Medicine Intervention
Primary Outcome Measure Information:
Title
Change in quality of life over 12 months
Description
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.
Time Frame
Baseline, 3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in fatigue over 12 months
Description
The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in sleep quality over 12 months
Description
The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in anxiety over 12 months
Description
The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in depressive symptoms over 12 months
Description
The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in pain over 12 months
Description
The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Change in diet over 12 months
Description
The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.
Time Frame
Baseline, 3 months, 6 months, 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Dhruva, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco, Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Integrative Approaches For Cancer Survivorship 2: Project 1

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