NCT03479385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

March 20, 2018

Last Update Submit

March 24, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life over 6 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. The scales range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales is the same in all cases: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

    Baseline, 3 months, 6 months

Secondary Outcomes (6)

  • Change in fatigue over 6 months

    Baseline, 3 months, 6 months

  • Change in sleep quality over 6 months

    Baseline, 3 months, 6 months

  • Change in anxiety over 6 months

    Baseline, 3 months, 6 months

  • Change in depressive symptoms over 6 months

    Baseline, 3 months, 6 months

  • Change in pain over 6 months

    Baseline, 3 months, 6 months

  • +1 more secondary outcomes

Study Arms (2)

Integrative Medicine Intervention

EXPERIMENTAL

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.

Behavioral: Integrative Medicine Intervention

Health Education Intervention

EXPERIMENTAL

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.

Behavioral: Health Education Intervention

Interventions

Integrative Medicine InterventionBEHAVIORAL

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.

Integrative Medicine Intervention
Health Education InterventionBEHAVIORAL

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

Health Education Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having received Ayurvedic treatment within 6 months of study enrollment
  • Patients on adjuvant hormone therapy for less than 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anand Dhruva, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

April 17, 2018

Primary Completion

February 6, 2019

Study Completion

January 30, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

US(1)