Anxiety Disorder, Colon Cancer, Depression, Fatigue, Rectal Cancer
Conditions
Brief summary
This randomized pilot trial studies mindfulness-based program in educating patients with colorectal cancer and their caregivers. A mindfulness-based exercise video may help reduce stress and fatigue in patients with colorectal cancer and their caregivers.
Detailed description
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.
Interventions
OTHEReducational intervention
Watch an educational video
PROCEDURECAM exercise therapy
Watch a mindfulness exercise video
Watch mindfulness exercise video and/or educational video
OTHERquestionnaire administration
Ancillary studies
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported stress levels assessed using pre- and post-test assessments | 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). |
| Change in colorectal cancer knowledge assessed using pre- and post-test assessments | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in salivary cortisol levels using chemiluminescence immunoassay | 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. |
Countries
United States
Outcome results
None listed