SHARE (Sharing Goals and Preferences) Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Dana Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02062
- Dana Farber Cancer Institute at St Elizabeth
-
Boston, Massachusetts, Forenede Stater, 02115
- Nancy Keating
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Enrollment
Tidsramme: 2 years
|
% of patients invited to participate who choose to enroll
|
2 years
|
|
Overall rating of intervention
Tidsramme: 1 month
|
% who rate intervention as good/very good/excellent.
|
1 month
|
|
Would recommend intervention to others
Tidsramme: 1 month
|
% who would recommend intervention to others with cancers like theirs
|
1 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Preferred format for viewing video and completing questionnaire
Tidsramme: 1 month
|
preferences for watching alone vs. with family; in clinic vs. home, interest in accessing via electronic record portal
|
1 month
|
|
Patient anxiety
Tidsramme: 1 month
|
Hospital Anxiety and Depression Scale (HADS) (score 0 to 21 for 7 anxiety items, higher=more anxiety)
|
1 month
|
|
Patient distress
Tidsramme: 1 month
|
National Comprehensive Cancer Network distress thermometer (score 0 to 10, higher worse distress)
|
1 month
|
|
Patient depression
Tidsramme: 1 month
|
Patient Health Questionnaire-9 (PHQ-9) (9 items, score 0 to 27, higher = more depressed)
|
1 month
|
|
Hope
Tidsramme: 1 month
|
Hearth Hope Index (12 items, score 12 to 48, higher = more hope)
|
1 month
|
|
FACIT-PAL Quality of Life
Tidsramme: 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
Tidsramme: 1 month
|
Palliative care subscale of FACITPAL (14 items, score 0 to 56, higher = better quality of life)
|
1 month
|
|
Therapeutic Alliance
Tidsramme: 1 month
|
Human Connection Scale (16 items, score 16 to 64, higher = more therapeutic alliance)
|
1 month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nancy L Keating, MD, Harvard Medical School (HMS and HSDM)
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 17-520
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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