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Improving Self-Management in Head and Neck Cancer

14 janvier 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Texas
      • Houston, Texas, États-Unis, 77030
        • Baylor College of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.
Aucune intervention: Usual Medical Care (UMC)
Patients receive standard symptom management education by their health care team.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of the CST intervention as assessed by recruitment and retention rates
Délai: 6 months
recruitment and retention rates
6 months
Acceptability of the CST intervention as assessed by the program evaluation questionnaire
Délai: 6 months
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
6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PROMIS short form anxiety and depression
Délai: 6 months
measures distress with Patient Reported Outcomes Measurement Information System (PROMIS) short form for anxiety and depression
6 months
Patient QOL measured by MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Délai: 6 months
measures QOL for patients
6 months
Partners QOL measured by Short Form 12 (SF12)
Délai: 6 months
measures QOL for partners
6 months
Short Form Dyadic Adjustment Scale (DAS7)
Délai: 6 months
measures Relationship functioning
6 months
Healthcare utilization as assessed by number of hospitalizations and unplanned clinic visits
Délai: 6 months
number of hospitalizations and unplanned clinic visits
6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Hoda Badr, PhD, Icahn School of Medicine at Mount Sinai

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2014

Achèvement primaire (Réel)

1 octobre 2018

Achèvement de l'étude (Réel)

1 avril 2019

Dates d'inscription aux études

Première soumission

1 avril 2015

Première soumission répondant aux critères de contrôle qualité

3 avril 2015

Première publication (Estimation)

6 avril 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 janvier 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 janvier 2020

Dernière vérification

1 janvier 2020

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GCO 12-1641
  • R21CA178478 (Subvention/contrat des NIH des États-Unis)
  • H-48778 (Autre identifiant: Baylor College of Medicine)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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