- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02409485
Improving Self-Management in Head and Neck Cancer
14 januari 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: Usual Medical Care (UMC)
Patients receive standard symptom management education by their health care team.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility of the CST intervention as assessed by recruitment and retention rates
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
PROMIS short form anxiety and depression
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 6 months
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number of hospitalizations and unplanned clinic visits
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6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Hoda Badr, PhD, Icahn School of Medicine at Mount Sinai
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2014
Primärt slutförande (Faktisk)
1 oktober 2018
Avslutad studie (Faktisk)
1 april 2019
Studieregistreringsdatum
Först inskickad
1 april 2015
Först inskickad som uppfyllde QC-kriterierna
3 april 2015
Första postat (Uppskatta)
6 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 januari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 januari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GCO 12-1641
- R21CA178478 (U.S.S. NIH-anslag/kontrakt)
- H-48778 (Annan identifierare: Baylor College of Medicine)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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