A Pilot Study of a Brief Pre-Operative Intervention for Patients Undergoing Breast Surgery

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

This study is to assess the feasibility of using a positive activities intervention, Positive Piggy Bank, in newly diagnosed women with breast cancer who will soon undergo surgery. A randomized controlled pilot trial of a brief self-guided positive activities intervention, The Positive Piggy Bank (PPB), compared to Treatment as Usual. The PPB intervention involves noting at least one positive event each day, writing it down on a slip of paper and then depositing this piece of paper in a piggy bank. This practice is to take place at the end of the day, every day over a circumscribed period of time. At the end of the "deposit period," in the case of this study after approximately 21 days, the participant "closes the account" and makes a full withdrawal by taking all of the slips out of the piggy bank and reading each one on the night before surgery.

Key facts

Study ID

NCT02939040

Run by

University of Michigan

People needed

22

Starts

2016-06-01

Expected to finish

2017-02-01

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Recent diagnosis of breast cancer with pending surgery as primary treatment for breast cancer.
• Ages 18 and above.
• Able to read/understand English and give consent.
• Willing and able to comply with all aspects of study procedures.
• No plan to initiate a new program that could affect well-being during the study period (e.g., psychotherapy, new exercise regimen, meditation classes).

You may not qualify if…

• Planned neoadjuvant systemic therapy.
• Having a psychotic disorder or the presence of another psychiatric condition (e.g., severe depression [i.e., score on the PHQ-9], suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study.
• Other factors that at the discretion of the investigators would adversely affect study.

Where it is running

• University of Michigan, Chronic Pain and Fatigue Research Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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