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
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90033
- USC Norris Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Group I (standard of care)
Patients and caregivers receive standard of care.
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Experimenteel: Group II (educational video)
Patients and caregivers receive a 20-minute self-playing interactive educational video brochure.
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Correlatieve studies
Nevenstudies
Watch an educational video
Andere namen:
Watch mindfulness exercise video and/or educational video
|
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Experimenteel: 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.
|
Correlatieve studies
Nevenstudies
Watch an educational video
Andere namen:
Watch mindfulness exercise video and/or educational video
Watch a mindfulness exercise video
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in self-reported stress levels assessed using pre- and post-test assessments
Tijdsspanne: Baseline to up to 60 minutes
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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).
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Baseline to up to 60 minutes
|
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Change in colorectal cancer knowledge assessed using pre- and post-test assessments
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in salivary cortisol levels using chemiluminescence immunoassay
Tijdsspanne: 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.
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Baseline to up 60 minutes
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jane Figueiredo, University of Southern California
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 3C-13-6 (Andere identificatie: USC Norris Comprehensive Cancer Center)
- P30CA014089 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2014-00164 (Register-ID: CTRP (Clinical Trial Reporting Program))
- R01CA155101 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
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