Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers
A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
Studieoversikt
Status
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. To evaluate the effect of a brief educational program on colorectal cancer knowledge acquisition in a 3-arm randomized clinical trial (Control Group: standard of care; Treatment Group 1: cancer education; Treatment Group 2: mindfulness + cancer education) comparing visual/written educational material with and without mindfulness training to the standard of care.
II. To determine the priming effect of a brief mindfulness training on retaining knowledge of colorectal cancer education.
III. To determine the joint effect of colorectal cancer education delivered to both the patient and a caregiver on the overall colorectal cancer knowledge.
SECONDARY OBJECTIVES:
I. To examine the relative changes in psychobiological variables (stress, anxiety, depression, mindfulness, fatigue, life benefit) from pre (T0) to post (T1) intervention in the 3 arms of the clinical trials.
II. To measure changes in salivary cortisol levels as an indicator of acute stress reactivity across 4 time points across a one-hour period (i.e., 0 min, 20 min, 40 min, 60 min) during active chemotherapy (T1).
III. To determine the moderating effect of baseline peripheral levels of inflammation (interleukin-1 [IL-1], IL-6, c-reactive protein [CRP] and tumor necrosis factor alpha [TNFa]) on the trajectory of salivary cortisol reactivity.
OUTLINE: Patients and caregivers are randomized to 1 of 3 groups.
GROUP I: Patients and caregivers receive standard of care.
GROUP II: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
GROUP III: Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90033
- USC Norris Comprehensive Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient diagnosed with colorectal cancer
- Patients with at least one more chemotherapy appointment at the time of enrollment
- if patients have a caregiver, patients should agree to bring a caregiver to one of their hospital visits or have the caregiver schedule a separate study visit
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Illiterate participants
- Deaf participants
- Participants that do not read speak or understand either Spanish or English
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Group I (standard of care)
Patients and caregivers receive standard of care.
|
|
|
Eksperimentell: Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
|
Korrelative studier
Hjelpestudier
Watch an educational video
Andre navn:
Watch mindfulness exercise video and/or educational video
|
|
Eksperimentell: Group III (educational video, mindfulness exercise video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video.
|
Korrelative studier
Hjelpestudier
Watch an educational video
Andre navn:
Watch mindfulness exercise video and/or educational video
Watch a mindfulness exercise video
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in self-reported stress levels assessed using pre- and post-test assessments
Tidsramme: Baseline to up to 60 minutes
|
The intervention effects will be examined using multi-level modeling (MLM).
These analyses will include chi-square, t-tests, and one way analyses of variance (ANOVAs).
|
Baseline to up to 60 minutes
|
|
Change in colorectal cancer knowledge assessed using pre- and post-test assessments
Tidsramme: Baseline to up to 60 minutes
|
The intervention effects will be examined using multi-level modeling (MLM).
These analyses will include chi-square, t-tests, and one way ANOVAs.
|
Baseline to up to 60 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in salivary cortisol levels using chemiluminescence immunoassay
Tidsramme: Baseline to up 60 minutes
|
Cortisol slopes will be calculated with two distinct areas under the curve analyses using the trapezoid formula as outlined by Pruessner 2003.
Data values will be entered into a two factor (group by time) multilevel MIXED linear regression model to calculate differences between the three groups.
A Scheffe post hoc test will be employed to determine the direction of the differences between the groups.
|
Baseline to up 60 minutes
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jane Figueiredo, University of Southern California
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 (Anslag)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3C-13-6 (Annen identifikator: USC Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH-stipend/kontrakt)
- NCI-2014-00164 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- R01CA155101 (U.S. NIH-stipend/kontrakt)
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