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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Individualized Manualized Health Education Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02897544

16-1856

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Health Education Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Individualized Manualized Health Education Intervention