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

3 octobre 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

22

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48106
        • University of Michigan, Chronic Pain and Fatigue Research Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of using a Positive Activities Intervention
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Symptom Burden
Délai: 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
Délai: 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
Délai: 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
Délai: Day 1 (baseline) to 14 Days Post Surgery
Measured by the PROMIS Profile 29
Day 1 (baseline) to 14 Days Post Surgery
Social Roles
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan

Les enquêteurs

  • Chercheur principal: Afton Hassett, Psy.D., University of Michigan

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2016

Achèvement primaire (Réel)

1 février 2017

Achèvement de l'étude (Réel)

1 février 2017

Dates d'inscription aux études

Première soumission

1 août 2016

Première soumission répondant aux critères de contrôle qualité

17 octobre 2016

Première publication (Estimation)

19 octobre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 octobre 2017

Dernière vérification

1 octobre 2017

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • HUM00114087
  • UMCC 2016.036 (Autre identifiant: University of Michigan Cancer Center)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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