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

31 juli 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

69

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80045
        • University of Colorado, Denver

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Behandeling zoals gebruikelijk
Gedragsmatig: 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.
Actieve vergelijker: 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.
Ander: Behandeling zoals gebruikelijk

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation of Exit Interviews
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Week 1
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tijdsspanne: Week 12
Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Evaluation of Self-report caregiver reported outcomes at baseline
Tijdsspanne: Week 1
Center for Epidemiologic Studies Depression Scale (CESD)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Tijdsspanne: Week 1
Perceived Stress Scale (PSS)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Tijdsspanne: Week 1
Female Sexual Function Index (FSFI)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Tijdsspanne: Week 1
Male Sexual Health Questionnaire(MSHQ)
Week 1
Evaluation of Self-report caregiver reported outcomes at baseline
Tijdsspanne: Week 1
Measure of Current Status (MOCS-A)
Week 1
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tijdsspanne: Week 12
Center for Epidemiologic Studies Depression Scale (CESD)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tijdsspanne: Week 12
Perceived Stress Scale (PSS)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tijdsspanne: Week 12
Female Sexual Function Index (FSFI)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tijdsspanne: Week 12
Male Sexual Health Questionnaire(MSHQ)
Week 12
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tijdsspanne: Week 12
Measure of Current Status (MOCS-A)
Week 12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Colorado, Denver

Medewerkers

Icahn School of Medicine at Mount Sinai

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2016

Primaire voltooiing (Werkelijk)

17 november 2017

Studie voltooiing (Werkelijk)

13 juli 2018

Studieregistratiedata

Eerst ingediend

28 september 2016

Eerst ingediend dat voldeed aan de QC-criteria

21 december 2016

Eerst geplaatst (Schatting)

26 december 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 augustus 2020

Laatste update ingediend die voldeed aan QC-criteria

31 juli 2020

Laatst geverifieerd

1 juli 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 16-0990

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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