SHARE (Sharing Goals and Preferences) Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The investigators are conducting a study with patients from Dana Farber Cancer Institute (DFCI) and DFCI-affiliate at St. Elizabeth's Hospital who are being treated for their cancer. The purpose of the study is to test the implementation of a short video, a brief questionnaire, and a wallet card designed to help patients understand and articulate their goals and preferences when making decisions about their cancer treatment and communicate these preferences to their clinicians.
The short video and brief questionnaire were developed to help patients with cancer think about their goals of care and their treatment and information preferences and to prompt discussions with their health care team about these preferences. The wallet card is designed to help patients remember some key questions that may be useful as they make decisions about future treatments
A pilot test will be completed to assess the feasibility and usability of the revised "More Good Days" video, brief questionnaire and wallet card in helping seriously-ill cancer patients think about what a good day means to them and test whether these tools can help patients to identify and communicate their medical treatment preferences and goals with their care team.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Dana Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02062
- Dana Farber Cancer Institute at St Elizabeth
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Boston, Massachusetts, États-Unis, 02115
- Nancy Keating
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Patient who are receiving treatment at:
- DFCI in the thoracic oncology group
- DFCI-affiliated St. Elizabeth's Hospital and have progressed on 2nd line or later-line systemic therapies (chemotherapy, immunotherapy, biological, or targeted therapies)
- Clinicians' schedules to identify patients with metastatic cancers who are considering or pursuing additional palliative therapy
Exclusion Criteria:
- Patients who are not interested in the study
- Patients of physicians who opt out of participating
- Patients whose physicians did not opt out, but whose physician does not think they are well suited for the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: More Good Days video&brief questionnaire
|
Help patients with advanced cancer think about what a good day means to them and to help them think about questions they may have for their physicians when discussing treatments
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Enrollment
Délai: 2 years
|
% of patients invited to participate who choose to enroll
|
2 years
|
|
Overall rating of intervention
Délai: 1 month
|
% who rate intervention as good/very good/excellent.
|
1 month
|
|
Would recommend intervention to others
Délai: 1 month
|
% who would recommend intervention to others with cancers like theirs
|
1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Preferred format for viewing video and completing questionnaire
Délai: 1 month
|
preferences for watching alone vs. with family; in clinic vs. home, interest in accessing via electronic record portal
|
1 month
|
|
Patient anxiety
Délai: 1 month
|
Hospital Anxiety and Depression Scale (HADS) (score 0 to 21 for 7 anxiety items, higher=more anxiety)
|
1 month
|
|
Patient distress
Délai: 1 month
|
National Comprehensive Cancer Network distress thermometer (score 0 to 10, higher worse distress)
|
1 month
|
|
Patient depression
Délai: 1 month
|
Patient Health Questionnaire-9 (PHQ-9) (9 items, score 0 to 27, higher = more depressed)
|
1 month
|
|
Hope
Délai: 1 month
|
Hearth Hope Index (12 items, score 12 to 48, higher = more hope)
|
1 month
|
|
FACIT-PAL Quality of Life
Délai: 1 month
|
FACIT-PAL instrument general quality of life (27 general items, score 0 to 108, higher=better quality of life)
|
1 month
|
|
Quality of life-palliative care specific items
Délai: 1 month
|
Palliative care subscale of FACITPAL (14 items, score 0 to 56, higher = better quality of life)
|
1 month
|
|
Therapeutic Alliance
Délai: 1 month
|
Human Connection Scale (16 items, score 16 to 64, higher = more therapeutic alliance)
|
1 month
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nancy L Keating, MD, Harvard Medical School (HMS and HSDM)
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 17-520
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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