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

3 oktober 2017 uppdaterad av: Afton Hassett, Psy.D., University of Michigan
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

22

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48106
        • University of Michigan, Chronic Pain and Fatigue Research Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of using a Positive Activities Intervention
Tidsram: 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.
Day 1 (baseline), Day of Surgery and 14 Days Post Surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Symptom Burden
Tidsram: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Measured by the MSAS
Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Fatigue
Tidsram: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Measured by the PROMIS Profile 29
Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Sleep
Tidsram: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Measured by the PROMIS Profile 29
Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Depressive Symptoms
Tidsram: Day 1 (baseline) to 14 Days Post Surgery
Measured by the PROMIS Profile 29
Day 1 (baseline) to 14 Days Post Surgery
Social Roles
Tidsram: Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
Measured by the PROMIS Profile 29
Day 1 (baseline), Day of Surgery and 14 Days Post Surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Michigan

Utredare

  • Huvudutredare: Afton Hassett, Psy.D., University of Michigan

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2016

Primärt slutförande (Faktisk)

1 februari 2017

Avslutad studie (Faktisk)

1 februari 2017

Studieregistreringsdatum

Först inskickad

1 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

17 oktober 2016

Första postat (Uppskatta)

19 oktober 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 oktober 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 oktober 2017

Senast verifierad

1 oktober 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • HUM00114087
  • UMCC 2016.036 (Annan identifierare: University of Michigan Cancer Center)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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