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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Positive Activities Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of a Brief Pre-Operative Intervention for Patients Undergoing Breast Surgery
Study Start Date : June 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Symptom Burden [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the MSAS

  2. Fatigue [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29

  3. Sleep [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29

  4. Depressive Symptoms [ Time Frame: Day 1 (baseline) to 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29

  5. Social Roles [ Time Frame: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery ]
    Measured by the PROMIS Profile 29



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939040


Locations
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United States, Michigan
University of Michigan, Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Afton Hassett, Psy.D. University of Michigan

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Responsible Party: Afton Hassett, Psy.D., Associate Research Scientist, University of Michigan
ClinicalTrials.gov Identifier: NCT02939040     History of Changes
Other Study ID Numbers: HUM00114087
UMCC 2016.036 ( Other Identifier: University of Michigan Cancer Center )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Afton Hassett, Psy.D., University of Michigan:
positive activities intervention
peri-operative