- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02409485
Improving Self-Management in Head and Neck Cancer
14. januar 2020 opdateret af: Hoda Badr, Baylor College of Medicine
By teaching skills to improve the coordination of care and support in couples coping with head and neck cancer (HNC), this couple-based psychosocial intervention holds great promise for improving self-management, reducing costly hospitalizations and treatment interruptions, and improving both partners' quality of life.
Home-based delivery will enhance future dissemination and outreach to those who do not have access to psychosocial services or live far away from their care centers.
If found effective, the intervention may also have salutary downstream effects on the health and well-being of HNC patients and their partners.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients treated with radiation (XRT) for head and neck cancers (HNCs) experience significant side effects such as abnormally reduced salivation, difficulty swallowing, and taste changes even after they have been definitively treated.
To control side effects and minimize discomfort, intensive self-care protocols are prescribed, but adherence is poor.
Partners (spouses/significant others) can play a critical role in supporting adherence, but often lack knowledge, experience high rates of distress, and display poor communication (e.g., critical or controlling), that can interfere with patient self-care.
The investigators have developed a home-based couples skills-training (CST) intervention that teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care and support; and 3) strategies to improve communal coping and confidence in the ability to work as a team.
The goal is to reduce healthcare utilization and improve multiple domains of patient and partner QOL.
Specific aims are to: develop and evaluate the content and materials of the CST intervention (AIM 1) and evaluate its feasibility and acceptability (AIM 2).
The multidisciplinary team will review and evaluate the content we have already developed based on the ongoing work with HNC couples (K07).
Once content is finalized, tailored manuals will be developed for patients and partners and evaluated through two focus groups (AIM 1).
The investigators expect that most couples (> 60%) approached will agree to participate and that CST will be well-accepted (AIM 2).
Knowledge gained will be used to refine CST and to collect data on effect sizes and variation for a larger trial.
Innovation: CST takes a multiple-behavioral approach to addressing and preventing HNC treatment side effects and, in the process, seeks to improve multiple domains of QOL.
It is also the first program in HNC that actively involves both members of the couple to address barriers in the home environment in which self-management occurs.
Finally, this study conceptualizes the couple relationship as a resource and leverages that resource to improve patient care and outcomes.
Impact: Home-based delivery will enhance future dissemination and outreach to the target population.
Overall, CST holds great promise for improving patient self-management behaviors, reducing costly hospitalizations and treatment interruptions, and improving multiple aspects of patient and partner QOL.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
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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Texas
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patient is initiating radiotherapy for HNC
- patient has Karnofsky score > 50 (ambulatory & capable of self-care)
- patient lives with a partner (spouse/significant other - includes homo- and heterosexual couples)
- patient/partner is able to provide informed consent
- patient/partner is > age 18.
Exclusion Criteria:
- patient has significant comorbidities (e.g., HIV, transplant), or another illness that may require hospitalization
- patient/partner cannot read or communicate using spoken English.
- individuals with diminished mental capacity
- prisoners
- pregnant women
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Couples Skill-Training (CST)
CST provides education about acute and long-term side-effects of HNC and teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care; and, 3) strategies to improve communal coping and confidence in the ability to work as a team.
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Patients and partners each receive a workbook and 6 one-hour telephone sessions with a Masters level trained interventionist.
Manual content is tailored based on role (patient or partner).
Couples participate together via speaker phone for half the sessions and patients and partners receive separate (individual) intervention calls for the other half of the sessions.
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Ingen indgriben: Usual Medical Care (UMC)
Patients receive standard symptom management education by their health care team.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of the CST intervention as assessed by recruitment and retention rates
Tidsramme: 6 months
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recruitment and retention rates
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6 months
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Acceptability of the CST intervention as assessed by the program evaluation questionnaire
Tidsramme: 6 months
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satisfaction with the intervention by completing a program evaluation questionnaire developed by the study team that asks about perceived skills mastery and satisfaction with program content and logistics
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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PROMIS short form anxiety and depression
Tidsramme: 6 months
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measures distress with Patient Reported Outcomes Measurement Information System (PROMIS) short form for anxiety and depression
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6 months
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Patient QOL measured by MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Tidsramme: 6 months
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measures QOL for patients
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6 months
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Partners QOL measured by Short Form 12 (SF12)
Tidsramme: 6 months
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measures QOL for partners
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6 months
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Short Form Dyadic Adjustment Scale (DAS7)
Tidsramme: 6 months
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measures Relationship functioning
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6 months
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Healthcare utilization as assessed by number of hospitalizations and unplanned clinic visits
Tidsramme: 6 months
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number of hospitalizations and unplanned clinic visits
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hoda Badr, PhD, Icahn School of Medicine at Mount Sinai
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. november 2014
Primær færdiggørelse (Faktiske)
1. oktober 2018
Studieafslutning (Faktiske)
1. april 2019
Datoer for studieregistrering
Først indsendt
1. april 2015
Først indsendt, der opfyldte QC-kriterier
3. april 2015
Først opslået (Skøn)
6. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 12-1641
- R21CA178478 (U.S. NIH-bevilling/kontrakt)
- H-48778 (Anden identifikator: Baylor College of Medicine)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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