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Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

31 luglio 2020 aggiornato da: University of Colorado, Denver

A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based Intervention) versus a treatment as usual control group. A total of 60 caregivers; including caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage III, solid tumor) will be enrolled in this study. The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame. The caregivers will be randomized to either treatment as usual or Pep-Pal intervention.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual control group. A total of 60 caregivers; caregivers of patients with HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer (Stage IV, solid tumor) will be enrolled in this study. The investigators do not expect different outcomes from these three groups, rather these populations are selected to optimize recruitment within a short time frame. The caregivers will be randomized to either treatment as usual or Pep-Pal intervention. The proposed study population is based on prior research indicating that caregivers of patients receiving HSCT, caregivers of patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer experience significant distress. In addition, an initial study of caregivers of patients receiving allogeneic-HSCT were able to benefit from a brief, cognitive behavioral stress management treatment approach. A study examining distress in phase I oncology clinical trial patient caregivers highlighted the need for more support for this significantly distressed population. Furthermore, initial results of the qualitative development study for Pep-Pal yielded support for a mobilized platform delivery of resources for caregivers to manage distress because they acknowledged many barriers to engaging in in-person treatment to manage distress.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

69

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

  • Stati Uniti
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado, Denver

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 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Women and men ≥ 18 years of age of any ethnicity
  2. Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and Anxiety Depression Scale (HADS))
  3. Speak and read in English
  4. Caregiver of a patient with auto HSCT who are moving forward with bone marrow transplant or have receive a bone marrow transplant
  5. Caregiver of a patient in a Phase I Clinical Trial
  6. Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV)
  7. No Cognitive or psychiatric conditions prohibiting participation
  8. Must meet criteria for being a primary caregiver, defined as, the person in the patient's life who is primarily responsible for care decisions, emotionally invested in the patient's care, provides instrumental care such as transportation for a patient receiving auto-HSCT, enrolled in a phase I oncology clinical trial, or of a patient diagnosed with advanced cancer (stage IV, solid tumor).
  9. Have a computer, smartphone, or tablet with internet access

Exclusion Criteria:

  1. Caregivers below the age of 18
  2. Score below an 8 on the Hospital and Anxiety Depression Scale (HADS)
  3. Cannot speak and read in English
  4. Patient does not receive a bone marrow transplant
  5. Patient is not enrolled in a Phase I clinical trial
  6. Patient is not diagnosed with Stage III or Stage IV cancer
  7. Cognitive conditions prohibiting participation

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: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Pep-Pal + Treatment as Usual
If the caregiver is assigned to the Pep-Pal intervention condition, the RA will provide access to the mobilized website (passcode) through an email. Caregivers will be instructed to watch each session at least once. It will be recommended that caregivers watch one to two new sessions per week so that they can have enough time to practice the skills between sessions. In addition, they will be told that they can go back and watch the sessions for review as many times as they like. Full participation will be defined as watching at least 7/9 sessions (75% of program) based on previous criteria for similar intervention completion in a prior trial with advanced cancer patients.
Altro: Trattamento come al solito
Comportamentale: Pep-Pal
Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained. In this way, Pep-Pal is a resource for our most hard to reach caregivers.
Comparatore attivo: Treatment as Usual
Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers.
Altro: Trattamento come al solito

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluation of Exit Interviews
Lasso di tempo: 12 weeks
Qualitative feedback will be gathered from the first 15 Pep-Pal completer's for individual interviews (5 from Phase I group, 5 from Hematopoietic stem cell transplantation (HSCT) group, 5 from medical oncology) upon completion of the follow-up assessments at 12 weeks about usage, acceptability of content, and impressions of using Pep-Pal.
12 weeks
Pep-Pal Self-Report sessions at 12 Weeks
Lasso di tempo: 12 weeks
The Investigators will assess feasibility by examining recruitment, retention, as well as reasons for refusal, frequency of sessions watched and length of time spent watching each session. Self report usage of peppal: Usage of Pep-Pal will be quantitatively assessed by asking each participant in the intervention group about their usage including frequency; how many times they watched each session and length of viewing for each session (partial or complete). They will be asked to rate level of usage based on a Likert-scale ranging from not at all to very often for each session (0-10). They will be asked to rank order the list of sessions from most helpful to least helpful.
12 weeks
Evaluation of Self-Report Caregiver reported outcomes at Baseline
Lasso di tempo: Week 1
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Lasso di tempo: Week 12
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Evaluation of Self-report caregiver reported outcomes at baseline
Lasso di tempo: Week 1
Center for Epidemiologic Studies Depression Scale (CESD)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Lasso di tempo: Week 1
Perceived Stress Scale (PSS)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Lasso di tempo: Week 1
Female Sexual Function Index (FSFI)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Lasso di tempo: Week 1
Male Sexual Health Questionnaire(MSHQ)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Lasso di tempo: Week 1
Measure of Current Status (MOCS-A)
Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Lasso di tempo: Week 12
Center for Epidemiologic Studies Depression Scale (CESD)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Lasso di tempo: Week 12
Perceived Stress Scale (PSS)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Lasso di tempo: Week 12
Female Sexual Function Index (FSFI)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Lasso di tempo: Week 12
Male Sexual Health Questionnaire(MSHQ)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Lasso di tempo: Week 12
Measure of Current Status (MOCS-A)
Week 12

Collaboratori e investigatori

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

Sponsor

University of Colorado, Denver

Collaboratori

Icahn School of Medicine at Mount Sinai

Investigatori

  • Investigatore principale: Nicole R Amoyal-Pensak, PhD, University of Colorado, Denver

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 dicembre 2016

Completamento primario (Effettivo)

17 novembre 2017

Completamento dello studio (Effettivo)

13 luglio 2018

Date di iscrizione allo studio

Primo inviato

28 settembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

21 dicembre 2016

Primo Inserito (Stima)

26 dicembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 agosto 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 luglio 2020

Ultimo verificato

1 luglio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 16-0990

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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