SHARE (Sharing Goals and Preferences) Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02215
- Dana Farber Cancer Institute
-
Boston, Massachusetts, Forente stater, 02062
- Dana Farber Cancer Institute at St Elizabeth
-
Boston, Massachusetts, Forente stater, 02115
- Nancy Keating
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Nancy L Keating, MD, Harvard Medical School (HMS and HSDM)
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 17-520
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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