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

NCT02939040 | Completed DMC

• 2 other identifiers: HUM00114087UMCC 2016.036
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

positive activities intervention; peri-operative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Symptom Burden

  Day 1 (baseline), Day of Surgery and 14 Days Post Surgery

• Fatigue

  Day 1 (baseline), Day of Surgery and 14 Days Post Surgery

• Sleep

  Day 1 (baseline), Day of Surgery and 14 Days Post Surgery

• Depressive Symptoms

  Day 1 (baseline) to 14 Days Post Surgery

• Social Roles

  Day 1 (baseline), Day of Surgery and 14 Days Post Surgery

Study Arms (2)

Positive Activities Intervention

EXPERIMENTAL

Patients will note at least one positive event each day, write it down on a slip of paper and then deposit this piece of paper in a piggy bank. After approximately 21 days, the participant reads each one the night before surgery.

Behavioral: Positive Activities

Usual Care Group

NO INTERVENTION

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.

Interventions

Positive Activities BEHAVIORAL

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.

Positive Activities Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan, Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Afton Hassett, Psy.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: October 19, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)