- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03272880
Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers
Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Cancer and Their Caregivers: A Feasibility Study
Studieoversikt
Detaljert beskrivelse
Objective:
Primary:
To assess the feasibility and acceptability of arts-based programming for community-dwelling cancer survivors and caregivers. Feasibility and acceptability will be assessed based on:
- Recruitment
- Participation
- Retention (drop-outs)
- Satisfaction
Secondary:
To assess the participants' ability to:
- Define goals and strategies using the contents of the program.
- Implement the strategies in their daily activities in the short-term.
- Continue to use these strategies after the program ends.
Exploratory:
To perform exploratory analyses on the impact of arts-based programming on health, resilience, and well-being.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic, Case Comprehensive Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Able to participate in all program sessions
- Cognitively able to consent to participate
- Speaks, reads, and writes English
- Diagnosis of cancer or caregiver of someone with cancer
Exclusion Criteria:
- Severe visual or auditory impairment
- Severe and/or uncontrolled comorbidity precluding safe participation in a physical activity program
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 |
|---|---|
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Eksperimentell: arts-based programming for cancer survivors and caregivers
This is a 8-week, arts-based, health, resilience, and well-being program.
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This feasibility study includes educational components and an experiential components which are assessed with pre- and post-tests.
The topics of these components include: Introduction to the Arts and Health; Music, Well-Being, and Resilience; Movement and Physical Activity; Art and Well-Being; Theater and Socialization; Art Appreciation and a Healthy Brain; and Summary/Integration of the Arts into Daily Lives.
The impact of this program will be assessed with qualitative follow-up interviews.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility: Number of participants recruited in the study
Tidsramme: Up to 8 weeks after beginning of study
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Study will be feasible if recruitment goal is met with 10-20 participants enrolled
|
Up to 8 weeks after beginning of study
|
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Feasibility: Average number of session attended by participants
Tidsramme: Up to 8 weeks after beginning of study
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Study will be feasible if average number of session attended will be greater than or equal to 4
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Up to 8 weeks after beginning of study
|
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Percent of patients who drop out of study
Tidsramme: Up to 8 weeks after beginning of study
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Study will be feasible if no more than 25% of patients drop out of study
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Up to 8 weeks after beginning of study
|
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Satisfaction Score
Tidsramme: Up to 8 weeks after beginning of study
|
Satisfaction will be high in post-test surveys
|
Up to 8 weeks after beginning of study
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Qualitative Impact of arts-based programming on health
Tidsramme: Up to 3 weeks after final session (11 weeks from beginning of study)
|
Impact of program on health described in phenomenological interviews
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Up to 3 weeks after final session (11 weeks from beginning of study)
|
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Qualitative Impact of arts based programming on resilience
Tidsramme: Up to 3 weeks after final session (11 weeks from beginning of study)
|
Impact of program on resilience described in phenomenological interviews
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Up to 3 weeks after final session (11 weeks from beginning of study)
|
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Qualitative Impact of arts based programming on well-being
Tidsramme: Up to 3 weeks after final session (11 weeks from beginning of study)
|
Impact of program on well-being described in phenomenological interviews
|
Up to 3 weeks after final session (11 weeks from beginning of study)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Lisa M Gallagher, MA, MT-BC, Cleveland Clinic, Case Comprehensive Cancer Center
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
- CASE14Z17
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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