- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05364372
SMLI With Hispanic Cancer Survivors and Caregivers
Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the proposed randomized controlled trial, the investigators will test the 12-week SMLI against an attention control condition in 107 dyads of Hispanic cancer survivors who have completed curative treatments within the past two years and their informal caregivers. A 12-week follow-up will determine the sustainability of the intervention. The primary outcome of this trial, vegetable and fruit intake in survivors (secondary in caregivers), will be measured at baseline, 13, and 25 weeks, using validated methods. Additional secondary and exploratory outcomes will add to the rigor of the trial and provide robust findings for future dissemination efforts.
Specific Aim #1: Test the efficacy of the SMLI as compared to attention control among Hispanic female cancer survivors and their caregivers with respect to:
- Increase in fruit and vegetable consumption (measured via self-reported 24-hour recall and objectively with carotenoid skin colorimetry)
- Increase in physical activity (Metabolic Equivalents hours/week of moderate to vigorous physical activity measured by actigraphy) and decrease in symptom severity index
Specific Aim #2: Determine the extent to which improvements in primary and secondary outcomes over weeks 13 and 25 are mediated by social support and self-efficacy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samantha Werts, MPH
- Phone Number: 520-626-8712
- Email: swerts@arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- Recruiting
- University of Arizona
-
Principal Investigator:
- Cynthia Thomson, MD
-
Contact:
- UACC IIT
- Email: UACC-IIT@uacc.arizona.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria for female Hispanic cancer survivors:
- 18 years of age or older;
- have access to a telephone,
- speak and understand English or Spanish;
- have finished curative intent treatment for cancer within the previous 10 years and do not have any subsequent cancer treatments planned, except for non-curative intent maintenance therapy, such as hormonal therapy;
- must have at least 1 of the 5 most common cancer-related symptoms (pain, sleep disturbance, anxiety, depression and/or fatigue) with a severity score of 4 or higher on a 0-10 rating scale (based on NCCN guidelines for symptom monitoring and management used successfully in past work); and
- has a caregiver willing to participate in the study with them.
Inclusion criteria for the caregivers (nominated by the survivor) are:
- age 18 or older;
- able to speak and understand English or Spanish;
- access to a telephone; and
- not currently treated for cancer preserving the distinction between survivor and caregiver. The caregiver can be of any race or ethnicity and any gender.
Exclusion criteria for survivors:
- Under the age of 18 years
- Does not have access to a telephone
- Completed treatment for cancer more than 1 year ago
- Currently receiving counseling or treatment for special diet or weight loss
- Does not have a caregiver willing to participate with them
Exclusion criteria for caregivers:
- Under the age of 18 years
- Does not have access to a telephone
- Currently receiving counseling or treatment for special diet or weight loss
- Currently being treated for cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Attention control
Dyads will receive mailed print education materials regarding healthy lifestyle (nutrition and physical activity) disseminated by ACS and NCI.
They will also receive 12 weekly phone calls to assess post-treatment related symptoms.
|
Dyads will receive 12 weekly phone calls to assess symptom management.
|
Experimental: Symptom management and lifestyle intervention
Dyads will receive 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity.
|
Survivor and caregiver dyads will work together with a coach to establish diet and physical activity change SMART goals.
Motivational interviewing based weekly coaching sessions will review symptom management and goal attainment and then enact strategies to modify goals to be more relevant and achievable.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vegetable and fruit intake at 13-weeks in survivors
Time Frame: Baseline to 13-weeks
|
Measured using data from 24-hour dietary recalls conducted on three randomly chosen days per timepoint including one weekend day and two weekdays.
Objective assessment will be conducted in 10% of the sample using the Veggie Meter® Skin Carotenoid Scanner which measures skin carotenoid levels.
|
Baseline to 13-weeks
|
Change from baseline vegetable and fruit intake at 25-weeks in survivors
Time Frame: Baseline to 25-weeks
|
Measured using data from 24-hour dietary recalls conducted on three randomly chosen days per timepoint including one weekend day and two weekdays.
Objective assessment will be conducted in 10% of the sample using the Veggie Meter® Skin Carotenoid Scanner which measures skin carotenoid levels.
|
Baseline to 25-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: Baseline, 13-weeks, and 25-weeks
|
Objective measurement will be completed using an Actigraph GTX9 accelerometer which participants will be mailed and then instructed to wear on the hip for seven continuous days.
From the Actigraph GTX9 we get daily minutes of moderate to vigorous physical activity, sleep, sedentary time, light physical activity, and steps taken.
Averages over 5-7 days will be used for physical activity measures (daily minutes of activity) to ensure validity and reliability.
Participants will also provide a self-report using a seven day recall of physical activity.
|
Baseline, 13-weeks, and 25-weeks
|
Symptom severity
Time Frame: Baseline, 13-weeks, and 25-weeks
|
The General Symptom Distress Scale will be used to evaluate 12 symptoms: shortness of breath, pain, sleep difficulties, diarrhea, constipation, numbness or tingling, swelling in hands and feet, difficulty concentrating, poor appetite, depression, anxiety, fatigue.
Respondents indicate presence of each symptom (yes/no) and rate its severity on the scale from 1 to 10.
|
Baseline, 13-weeks, and 25-weeks
|
Vegetable and fruit intake in caregivers
Time Frame: Baseline, 13-weeks, and 25-weeks
|
Measured using data from 24-hour dietary recalls conducted on three randomly chosen days per timepoint including one weekend day and two weekdays.
Objective assessment will be conducted in 10% of the sample using the Veggie Meter® Skin Carotenoid Scanner which measures skin carotenoid levels.
|
Baseline, 13-weeks, and 25-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Thomson, MD, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 35221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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