A Pilot Study of a Brief Pre-Operative Intervention for Patients Undergoing Breast Surgery
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48106
- University of Michigan, Chronic Pain and Fatigue Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of using a Positive Activities Intervention
기간: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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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.
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Symptom Burden
기간: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the MSAS
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Fatigue
기간: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Sleep
기간: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Depressive Symptoms
기간: Day 1 (baseline) to 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline) to 14 Days Post Surgery
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Social Roles
기간: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Afton Hassett, Psy.D., University of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HUM00114087
- UMCC 2016.036 (기타 식별자: University of Michigan Cancer Center)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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Positive Activities에 대한 임상 시험
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Edward KasaraskisNational Institute of Neurological Disorders and Stroke (NINDS)완전한
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University Hospital, GrenobleONIRIS종료됨
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Children's Hospitals and Clinics of Minnesota종료됨
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Daping Hospital and the Research Institute of Surgery...알려지지 않은
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University of British Columbia빼는