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

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ClinicalTrials.gov Identifier: NCT02939040
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Afton Hassett, Psy.D., University of Michigan

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date October 6, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Feasibility of using a Positive Activities Intervention [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02939040 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Symptom Burden [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the MSAS
  • Fatigue [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29
  • Sleep [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29
  • Depressive Symptoms [ Time Frame: Day 1 (baseline) to 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29
  • Social Roles [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of a Brief Pre-Operative Intervention for Patients Undergoing Breast Surgery
Official Title  ICMJE A Pilot Study of a Brief Pre-Operative Intervention for Patients Undergoing Breast Surgery
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Positive Activities Intervention
    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.
    Intervention: Behavioral: Positive Activities
  • No Intervention: Usual Care Group
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
50
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939040
Other Study ID Numbers  ICMJE HUM00114087
UMCC 2016.036 ( Other Identifier: University of Michigan Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Afton Hassett, Psy.D., University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Afton Hassett, Psy.D. University of Michigan
PRS Account University of Michigan
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP