Integrative Approaches for Cancer Survivorship 2: Project 2 (IACS2)

Developing a Health Education Intervention for Breast Cancer Survivorship

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Individualized Manualized Health Education Intervention

Detailed Description

Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. The investigators aim to develop and test a Health Education intervention in breast cancer survivors. Specifically, the investigators aim to develop the manualized Health Education intervention; to assess feasibility; and to provide preliminary data on the effects of the intervention. The data from this pilot study will be used to inform future study.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco, Osher Center for Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Education Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Anand Dhruva, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 16-1856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO