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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939040
• Other study ID #: HUM00114087
• Secondary ID: UMCC 2016.036
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: October 3, 2017
• Start date: June 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Fifty participants will complete questionnaires at baseline (Day 1), then they will be randomized 1:1 to the Positive Piggy Bank condition (n=25) or Treatment as Usual (n = 25) approximately 3 weeks before surgery. Post-intervention (Day of Surgery) and 14 days post-surgery, participants will complete the same questionnaires. The 14 day post surgery questionnaires will be administered by phone.

Intervention Procedures - The Positive Piggy Bank. Participants randomized to this group will first get an overview of the intervention, learn about the rationale for this treatment, and receive supplies including the instructions on a decorative card, a piggy bank, and paper currency slips (pieces of lined paper with a place for the date). Participants in this group will be instructed to do the activities as detailed above in the Positive Piggy Bank instructions daily until the evening before surgery (approximately 21 days). On the evening before surgery, they are to "close their account" by opening the piggy bank and reviewing all of the slips of paper.

Study personnel will contact patients within 72 hours of beginning the study to answer questions and/or provide encouragement. Participants will also be contacted on the day before surgery to let them know that they should read all of their currency slips and reminded to bring their currency slips with them to the hospital on the day of surgery.

On the day of surgery, prior to surgery they will complete the first set of follow-up questionnaires. They will also be reminded that these same follow-up questionnaires will be administered by phone 14 days after surgery.

The control group will serve to show the relative benefits of the Positive Piggy Bank intervention. These participants will follow the same questionnaire completion procedures as listed above including phone calls. The phone call at 72 hours will be to simply thank them for their participation in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Recent diagnosis of breast cancer with pending surgery as primary treatment for breast cancer.

2. Ages 18 and above.

3. Able to read/understand English and give consent.

4. Willing and able to comply with all aspects of study procedures.

5. No plan to initiate a new program that could affect well-being during the study period (e.g., psychotherapy, new exercise regimen, meditation classes).

Exclusion Criteria:

1. Planned neoadjuvant systemic therapy.

2. 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.

3. Other factors that at the discretion of the investigators would adversely affect study.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Positive Activities
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" 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 the night before surgery.

Locations

Country	Name	City	State
United States	University of Michigan, Chronic Pain and Fatigue Research Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using a Positive Activities Intervention	The primary objective of 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. We will also explore changes in subjective well-being and post-surgical symptoms in response to the intervention in order to power a larger trial.	Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Secondary	Symptom Burden	Measured by the MSAS	Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Secondary	Fatigue	Measured by the PROMIS Profile 29	Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Secondary	Sleep	Measured by the PROMIS Profile 29	Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Secondary	Depressive Symptoms	Measured by the PROMIS Profile 29	Day 1 (baseline) to 14 Days Post Surgery
Secondary	Social Roles	Measured by the PROMIS Profile 29	Day 1 (baseline), Day of Surgery and 14 Days Post Surgery