Integrative Approaches for Cancer Survivorship 2: Project 2

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Individualized Manualized Health Education Intervention

• Registration Number: NCT02897544
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Primary Completion: 2018-06-04
• Study Completion: 2018-06-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health Education Intervention	Individualized Manualized 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.

Primary Outcome Measures

Name	Time	Method
Change in quality of life over 6 months	Baseline, 3 months, 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Francisco, Osher Center for Integrative Medicine; 🇺🇸 San Francisco, California, United States