Integrative Approaches for Cancer Survivorship 2: Project 2

Breast Cancer Clinical Trial

— IACS2  

Official title:

Developing a Health Education Intervention for Breast Cancer Survivorship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897544
• Other study ID #: 16-1856
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 4, 2018

Study information

• Verified date: March 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Individualized Manualized Health Education Intervention

Locations

Country	Name	City	State
United States	University of California, San Francisco, Osher Center for Integrative Medicine	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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