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

5 marzo 2019 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 69 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Emotion Regulation Therapy
8 sessions of Emotion Regulation Therapy.
Comportamentale: Emotion Regulation Therapy
8 sessions of ERT
Nessun intervento: Usual Medical Care
No planned psychotherapy.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in The Caregiver Reaction Assessment and EORTC-QLQ-30
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Difficulty in Emotion Regulation Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Aarhus

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2015

Completamento primario (Effettivo)

25 giugno 2018

Completamento dello studio (Effettivo)

31 dicembre 2018

Date di iscrizione allo studio

Primo inviato

4 dicembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

22 dicembre 2014

Primo Inserito (Stima)

23 dicembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 marzo 2019

Ultimo verificato

1 giugno 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ERT15-17

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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