Anxiety DisorderNCT02057991
Mindfulness-Based Exercise Video in Educating Hispanic/Latino Patients With Colorectal Cancer and Their Caregivers
A study testing educational intervention, CAM exercise therapy and caregiver-related intervention or procedure in people with Anxiety Disorder and Colon Cancer, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorder, Colon Cancer, Depression
- What is being tested?
- educational intervention, CAM exercise therapy and caregiver-related intervention or procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2014to 9 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Illiterate participants
- Deaf participants
- Participants that do not read speak or understand either Spanish or English
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Anxiety Disorder, Colon Cancer, Depression, Fatigue, Rectal Cancer
- Being tested
- educational intervention, CAM exercise therapy, caregiver-related intervention or procedure, questionnaire administration, laboratory biomarker analysis
- Medical subject headings
- Anxiety Disorders, Colonic Neoplasms, Depression, Fatigue, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Watch an educational video
CAM exercise therapyProcedure or surgery
Also called Exercise Therapy
Watch a mindfulness exercise video
caregiver-related intervention or procedureOther
Watch mindfulness exercise video and/or educational video
questionnaire administrationOther
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (standard of care) | No intervention | Patients and caregivers receive standard of care. |
| Group II (educational video) | Experimental | Patients and caregivers receive a 20-minute self-playing interactive educational video brochure. Receives: Other: educational intervention; Other: caregiver-related intervention or procedure; Other: questionnaire administration; Other: laboratory biomarker analysis |
| Group III (educational video, mindfulness exercise video) | Experimental | Patients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video. Receives: Other: educational intervention; Procedure: CAM exercise therapy; Other: caregiver-related intervention or procedure; Other: questionnaire administration; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported stress levels assessed using pre- and post-test assessments
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).
Measured: Baseline to up to 60 minutes
Change in colorectal cancer knowledge assessed using pre- and post-test assessments
The intervention effects will be examined using multi-level modeling (MLM). These analyses will include chi-square, t-tests, and one way ANOVAs.
Measured: Baseline to up to 60 minutes
Secondary outcomes (1)
Changes in salivary cortisol levels using chemiluminescence immunoassay
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.
Measured: Baseline to up 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study start7 Jan 2014
- Primary completion9 Nov 2016
- Study completion9 Nov 2017
Why it stopped: Insufficient Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jane Figueiredo, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057991
- Sponsor's protocol ID
- 3C-13-6
- Other IDs
- NCI-2014-00164, 3C-13-6, R01CA155101, P30CA014089
- Status last verified
- Nov 2017
- First submitted
- 5 Feb 2014
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-Based Educational Intervention For Colorectal Cancer Patients And Caregivers
- ClinicalTrials.gov ID
- NCT02057991
- Acronym / sponsor ID
- 3C-13-6
- Conditions
- Anxiety Disorder, Colon Cancer, Depression, Fatigue, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jan 2014 (actual)
- Primary completion
- 9 Nov 2016 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (standard of care) | No intervention | –Patients and caregivers receive standard of care. |
| Group II (educational video) | Experimental | Other: educational intervention, Other: caregiver-related intervention or procedure, Other: questionnaire administration, Other: laboratory biomarker analysisPatients and caregivers receive a 20-minute self-playing interactive educational video brochure. |
| Group III (educational video, mindfulness exercise video) | Experimental | Other: educational intervention, Procedure: CAM exercise therapy, Other: caregiver-related intervention or procedure, Other: questionnaire administration, Other: laboratory biomarker analysisPatients and caregivers receive a 20-minute self-playing interactive educational video brochure and watch a 20-minute interactive mindfulness exercise video. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Illiterate participants
- Deaf participants
- Participants that do not read speak or understand either Spanish or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational interventionAlso: intervention, educationalWatch an educational video | Other | Group II (educational video), Group III (educational video, mindfulness exercise video) |
| CAM exercise therapyAlso: Exercise TherapyWatch a mindfulness exercise video | Procedure or surgery | Group III (educational video, mindfulness exercise video) |
| caregiver-related intervention or procedureWatch mindfulness exercise video and/or educational video | Other | Group II (educational video), Group III (educational video, mindfulness exercise video) |
| questionnaire administrationAncillary studies | Other | Group II (educational video), Group III (educational video, mindfulness exercise video) |
| laboratory biomarker analysisCorrelative studies | Other | Group II (educational video), Group III (educational video, mindfulness exercise video) |
Primary outcome
Change in self-reported stress levels assessed using pre- and post-test assessments
Time frame: 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
Time frame: 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.
1 secondary outcome
Changes in salivary cortisol levels using chemiluminescence immunoassay
Time frame: Baseline to up 60 minutes
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Figueiredo principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, CAM exercise therapy and caregiver-related intervention or procedure in people with Anxiety Disorder and Colon Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported stress levels assessed using pre- and post-test assessments (time frame: Baseline to up to 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.