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Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial (ERT-ICs)

5. März 2019 aktualisiert von: University of Aarhus

Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial

Informal caregivers of cancer patients report high levels of psychological distress as evidenced in markedly increased levels of anxiety and depression. High levels of psychological distress in caregivers have also been found to be associated with poorer health and increased levels of pro-inflammatory cytokines that are well-established risk factors for physical illness and stress-related mortality. Previous psychological interventions using cognitive methods have only produced small effect sizes and more research on how to effectively alleviate caregiver burden is needed. The proposed project will investigate the effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel approach specifically targeting emotion regulation with the aim of improving mental and physical health. The effect of ERT will be examined in a randomized controlled trial comparing ERT to usual medical care (UMC).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PURPOSE:

The primary purpose of the study is to test the efficacy of Emotion Regulation Therapy (ERT) for informal caregivers (ICs) of cancer patients. ERT is a manualized treatment for ICs and consists of 8 weekly sessions.

AIMS AND HYPOTHESES:

Intervention and mediation effects. In an RCT, the investigators will investigate the efficacy of an 8 session ERT for ICs on psychological and physical distress and a number of other health outcomes in both ICs and cancer patients. Outcomes in the ERT group will be compared to outcomes in a group of ICs and patients receiving usual medical care (UMC) (see Figure 1). ICs receiving ERT compared to ICs receiving UMC are expected to exhibit 1a) significant reductions in psychological distress and perceived caregiving burden, 1b) improvements in quality of life; and 1c) improvements in pro-inflammatory markers of stress/immune functioning. Likewise, patients whose ICs receive ERT are expected to report 2a) reduced anxiety and depression, 2b) improved quality of life and 2c) less chronic inflammation. Due to the design, these effects will be considered following the acute treatment period (pre, mid and post therapy). In addition to this, gains are expected to be maintained over the follow-up-period. In addition, 3) improvements are exptected to be maintained over the follow-up period. Finally, 4) improvements in adaptive emotion regulation (mindfulness, acceptance, and cognitive reappraisal) are expected to mediate the effect of ERT.

PARTICIPANTS AND PROCEDURES:

ICs of cancer patients with various cancer types will be consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinic at the Department of Oncology, Aarhus University Hospital, Denmark, will screen ICs at the department. Initially the investigators wanted to include caregivers of patients with lung and colorectal cancer only. However, in order to be able to include caregivers at a faster pace, it was decided - after one month during which only two caregivers were included - to broaden the patient group. Furthermore, it was decided that more than one IC per patient could participate.

After giving informed consent, participants will be randomized to Emotion Regulation Therapy (ERT) or usual medical care (UMC) in a ratio of 1:1 by means of computer-generated randomization lists. Outcome measures will be obtained pre-, mid-, and post-therapy as well as at 3 and 6-month follow-up. At every ERT session, ICs and clinicians will fill out a number of self-report the process measures. Cancer patients will be assessed pre- and post ERT, and at 3 and 6-months follow-up. Every IC and patient will provide blood samples before and after the intervention as well as at follow-ups.

Based on a power calculation (alpha=0.0125, beta=0.90), a dropout rate of 35%, and an intraclass correlation between ICs of the same patient of 0.20, the inclusion of 80 ICs will allow for an interaction effect between group (ERT vs. UMC) and time (acute treatment, thats is, pre, mid and post) of a medium effect size (d=0.5) to be significant.

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

  • Dänemark
      • Aarhus C, Dänemark, DK8000
        • Unit for Psychooncology and Health Psychology

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

18 Jahre bis 69 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Medium levels of distress (distress thermometer > 3) and at least moderate levels of worry or rumination
  • Caregiver of patient with cancer

Exclusion Criteria:

  • an expected survival of the patient of <6 months,
  • active substance abuse (alcohol or drugs), and
  • participation in other psychosocial trials.

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: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Emotion Regulation Therapy
8 sessions of Emotion Regulation Therapy.
Verhalten: Emotion Regulation Therapy
8 sessions of ERT
Kein Eingriff: Usual Medical Care
No planned psychotherapy.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in The Caregiver Reaction Assessment and EORTC-QLQ-30
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring burden in ICs and quality of life cancer patients, respectively
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring anxiety and depression
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Penn State Worry Questionnaire
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring worry
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Rumination Response Scale - Brooding subscale only
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring brooding
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Difficulty in Emotion Regulation Scale
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring emotion regulation
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Emotion Regulation Questionnaire
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring emotion regulation
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Five Facet Mindfulness Questionnaire
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring mindfulness
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Experiences Questionnaire
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring psychological distancing
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in The Pittsburgh Sleep Quality Index
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring sleep quality
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in quality of life - WHO-5
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring quality of life
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Change in Pro-inflammatory markers: CRP, TNFalpha, IL-1, IL-6
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, and post-therapy).
Serum-derived pro-inflammatory markers (only pre and post therapy)
Between-group effect at post, based on the whole treatment duration (pre-, and post-therapy).
Emotional closeness
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
2 items (actual and wanted emotional closeness) rated on a 0-10 scale
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Emotional attention coping (EAC)
Zeitfenster: Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
Questionnaire measuring emotion regulation
Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

Mitarbeiter und Ermittler

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

Sponsor

University of Aarhus

Ermittler

  • Hauptermittler: Mia S O'Toole, MSc, University of Aarhus

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.

Allgemeine Veröffentlichungen

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)

1. August 2015

Primärer Abschluss (Tatsächlich)

25. Juni 2018

Studienabschluss (Tatsächlich)

31. Dezember 2018

Studienanmeldedaten

Zuerst eingereicht

4. Dezember 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Dezember 2014

Zuerst gepostet (Schätzen)

23. Dezember 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. März 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. März 2019

Zuletzt verifiziert

1. Juni 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ERT15-17

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