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I HEAL for Breast Cancer Survivors With Diabetes (I HEAL)

28. Februar 2022 aktualisiert von: Duke University

Improving Health Engagement and Lifestyle Management for Breast Cancer Survivors With Diabetes

The proposed randomized clinical trial evaluates a diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST protocol integrates three key strategies to reduce symptoms and improve diabetes self-management: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. The investigator will test the effects of the DCST intervention by comparing it to diabetes education alone. Physical symptoms, psychological distress, diabetes self-management behaviors, and self-efficacy for managing symptoms and diabetes self-management will be assessed at baseline and 3, 6, and 12 months. Physical activity (i.e., daily steps and distance) will be assessed using wireless activity trackers and data will be obtained from home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

Together, breast cancer and type 2 diabetes represent a public health crisis. Approximately 20% of the 3.1 million breast cancer survivors in the U.S. have type 2 diabetes, and this number is expected to grow. Breast cancer survivors who have type 2 diabetes are at high risk for cancer recurrence, serious health complications, and premature death. Breast cancer survivors with type 2 diabetes experience more severe, disabling symptoms and psychological distress relative to breast cancer survivors without diabetes. For breast cancer survivors with type 2 diabetes, maintaining glycemic control is critical for decreasing symptoms and preventing serious health problems. Important diabetes self-management strategies include physical activity, dietary modifications, medication, and blood glucose monitoring. Many breast cancer survivors with type 2 diabetes have difficulty maintaining these behaviors and achieving glycemic control. Physical symptoms and psychological distress are often barriers to engaging in diabetes self-management. The proposed study evaluates a novel diabetes coping skills training (DCST) intervention for improving breast cancer survivors' abilities to manage symptoms and adhere to recommended diabetes self-management. The telephone-based DCST protocol is based on our prior work and integrates three key theory-based strategies: coping skills training for managing symptoms, adherence skills training, and healthy lifestyle skills training. The proposed randomized clinical trial (N=230) will test the effects of the DCST intervention by comparing it to diabetes education alone. Physical symptoms, psychological distress, diabetes self-management behaviors, and self-efficacy will be assessed at baseline and 3, 6, and 12 months. Physical activity will be assessed using wireless activity trackers and data will be obtained from home blood glucose monitoring devices. Glycosylated hemoglobin (HbA1c) will be assessed at baseline, 6, and 12 months. The proposed study addresses a critical gap in the care of breast cancer survivors by evaluating a novel behavioral intervention that aims to improve the management of symptoms, adherence, and glycemic control in breast cancer survivors with type 2 diabetes. The findings of this study could lead to significant improvements in clinical care and beneficial outcomes for breast cancer survivors.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Duke University Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • diagnosis of Stage I to III breast cancer,
  • diagnosis of diabetes mellitus type 2
  • completed local definitive treatment (i.e., surgical treatment, chemotherapy and/or radiation therapy),
  • physician verification of ability to participate in the intervention,
  • English speaking.

Exclusion Criteria:

  • <21 years of age,
  • severe cognitive or hearing impairment,
  • unable to provide meaningful consent (i.e., impairment such that descriptions of the research are not clearly understood),
  • presence of a health problem that precludes safe participation in the intervention.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Diabetes Coping Skills training (DCST)
Twelve sessions are delivered over 6 months using a faded contact model involving 6 weekly sessions, 3 biweekly sessions and 3 monthly sessions.
Diabetes Coping Skills Training (DCST) consist of twelve 50 minutes sessions delivered over 6 months using a faded contact model ( 6 weekly session, 3 biweekly sessions and 3 monthly sessions)
Kein Eingriff: Diabetes Education
one 60 minute diabetes education session.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in physical symptoms
Zeitfenster: baseline, 3 months, 6 months and 12 months
The Checklist measures the severity of different symptoms (e.g., pain, fatigue, numbness and tingling) associated with illness and disease.
baseline, 3 months, 6 months and 12 months
Change in psychological distress
Zeitfenster: baseline, 3 months, 6 months and 12 months
The eight-item Patient Reported Outcomes Information System (PROMIS).
baseline, 3 months, 6 months and 12 months
Change in psychological distress
Zeitfenster: baseline, 3 months, 6 months and 12 months
Anxiety will be assessed using the seven-item GAD-7 Scale.
baseline, 3 months, 6 months and 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Accessing change in Diabetes self-management behaviors via self reported medication adherence
Zeitfenster: Baseline to 12 months
Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.
Baseline to 12 months
Accessing change in Diabetes self-management behavior via Barriers to taking medication
Zeitfenster: Baseline to 12 months
Participants who receive DCST will exhibit greater improvements in medication adherence compare to the education group.
Baseline to 12 months
Accessing change in Diabetes self-management behavior via Adherence to diabetes self-management behaviors
Zeitfenster: Baseline to 12 months
Participants who receive DCST will exhibit greater improvements in physical activity, dietary patterns, medication adherence, and adherence to blood glucose monitoring compare to the education group.
Baseline to 12 months
Accessing change in Diabetes self-management behavior via Use of home blood glucose monitoring
Zeitfenster: Baseline, 6 months and 12 months
Participants who receive DCST will exhibit greater improvements in adherence to blood glucose monitoring compare to the education group.
Baseline, 6 months and 12 months
Improved glycemic control
Zeitfenster: Baseline, 6 months and 12 months
Participants who receive DCST will show greater improvements in HbA1c compared to the diabetes education alone.
Baseline, 6 months and 12 months
Change in self-efficacy
Zeitfenster: Baseline, 6 months and 12 months
This contains 5 items that inquire about patients' certainty about degree of pain control, pain during daily activities, controlling pain during sleep, and making pain reductions without extra medication.
Baseline, 6 months and 12 months
Change in Physical Activity
Zeitfenster: Baseline, 6 months and 12 months

Patient-reported physical activity will be assessed using the well-validated Community Healthy Activities Model Program for Seniors (CHAMPS).

Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.

Baseline, 6 months and 12 months
Assessing change in Physical Activity
Zeitfenster: Baseline, 6 months and 12 months

Wireless activity tracking devices will be used to assess daily steps and distance.

Participants who receive DCST will show improved self efficacy for managing symptoms and diabetes self-management compared to the diabetes education alone.

Baseline, 6 months and 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. April 2017

Primärer Abschluss (Tatsächlich)

1. Dezember 2021

Studienabschluss (Tatsächlich)

1. Dezember 2021

Studienanmeldedaten

Zuerst eingereicht

21. Oktober 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. November 2016

Zuerst gepostet (Schätzen)

22. November 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. März 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Februar 2022

Zuletzt verifiziert

1. Februar 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • Pro00073234

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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