Integrative Approaches for Cancer Survivorship 2: Project 2

NCT02897544 | Completed DMC

• 1 other identifier: 16-1856
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in quality of life over 6 months

  The investigators will use the EORTC QLQ C30 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related 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

Study Arms (1)

Health Education Intervention

EXPERIMENTAL

Study participants will attend Health Education sessions led by health educators over the course of 6 months. The emphasis in the sessions will be to provide engaging educational information on common survivorship issues.

Behavioral: Individualized Manualized Health Education Intervention

Interventions

Individualized Manualized Health Education Intervention BEHAVIORAL

Health Education Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (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:

• Patients on adjuvant hormone therapy for less than 2 months

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

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 Site; Neoplasms; Breast Diseases; Skin Diseases; Skin 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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 13, 2016
• Study Start: September 1, 2016
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)