- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03002896
Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness
31. juli 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
69
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado, Denver
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Women and men ≥ 18 years of age of any ethnicity
- Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and Anxiety Depression Scale (HADS))
- Speak and read in English
- Caregiver of a patient with auto HSCT who are moving forward with bone marrow transplant or have receive a bone marrow transplant
- Caregiver of a patient in a Phase I Clinical Trial
- Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV)
- No Cognitive or psychiatric conditions prohibiting participation
- 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).
- Have a computer, smartphone, or tablet with internet access
Exclusion Criteria:
- Caregivers below the age of 18
- Score below an 8 on the Hospital and Anxiety Depression Scale (HADS)
- Cannot speak and read in English
- Patient does not receive a bone marrow transplant
- Patient is not enrolled in a Phase I clinical trial
- Patient is not diagnosed with Stage III or Stage IV cancer
- Cognitive conditions prohibiting participation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
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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.
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Aktiv komparator: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Evaluation of Exit Interviews
Tidsramme: 12 weeks
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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.
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12 weeks
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Pep-Pal Self-Report sessions at 12 Weeks
Tidsramme: 12 weeks
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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.
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12 weeks
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Evaluation of Self-Report Caregiver reported outcomes at Baseline
Tidsramme: Week 1
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Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tidsramme: Week 12
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Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
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Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Evaluation of Self-report caregiver reported outcomes at baseline
Tidsramme: Week 1
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Center for Epidemiologic Studies Depression Scale (CESD)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
Tidsramme: Week 1
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Perceived Stress Scale (PSS)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
Tidsramme: Week 1
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Female Sexual Function Index (FSFI)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
Tidsramme: Week 1
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Male Sexual Health Questionnaire(MSHQ)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at baseline
Tidsramme: Week 1
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Measure of Current Status (MOCS-A)
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Week 1
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tidsramme: Week 12
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Center for Epidemiologic Studies Depression Scale (CESD)
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Week 12
|
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tidsramme: Week 12
|
Perceived Stress Scale (PSS)
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Week 12
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Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tidsramme: Week 12
|
Female Sexual Function Index (FSFI)
|
Week 12
|
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tidsramme: Week 12
|
Male Sexual Health Questionnaire(MSHQ)
|
Week 12
|
Evaluation of Self-report caregiver reported outcomes at 12 weeks
Tidsramme: Week 12
|
Measure of Current Status (MOCS-A)
|
Week 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nicole R Amoyal-Pensak, PhD, University of Colorado, Denver
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Pensak NA, Carr AL, Jones J, Mikulich-Gilbertson SK, Kutner JS, Kilbourn K, Sannes TS, Brewer BB, Kolva E, Joshi T, Laudenslager ML. A pilot study of mobilized intervention to help caregivers of oncology patients manage distress. Psychooncology. 2021 Apr;30(4):520-528. doi: 10.1002/pon.5597. Epub 2020 Dec 2.
- Carr AL, Jones J, Mikulich Gilbertson S, Laudenslager ML, Kutner JS, Kilbourn K, Sannes TS, Brewer BW, Kolva E, Joshi T, Amoyal Pensak N. Impact of a Mobilized Stress Management Program (Pep-Pal) for Caregivers of Oncology Patients: Mixed-Methods Study. JMIR Cancer. 2019 May 3;5(1):e11406. doi: 10.2196/11406.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2016
Primær færdiggørelse (Faktiske)
17. november 2017
Studieafslutning (Faktiske)
13. juli 2018
Datoer for studieregistrering
Først indsendt
28. september 2016
Først indsendt, der opfyldte QC-kriterier
21. december 2016
Først opslået (Skøn)
26. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-0990
Plan for individuelle deltagerdata (IPD)
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