Clinical trial NCT05364372: SMLI With Hispanic Cancer Survivors and Caregivers
Official title: Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivors
Cancer
Keywords: Cancer survivors
Caregivers
Symptom assessment
Lifestyle intervention
Diet
Physical activity
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-05-06
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fewer than 20% of Hispanic cancer survivors meet the American Cancer Society's (ACS) Guidelines on Nutrition and Physical Activity. Diagnosed at younger ages, later stages and with fewer resources (e.g., access to care), Hispanic cancer survivors are more likely to suffer from many symptoms, which linger long after they have completed treatment and may prevent them from leading a healthy life. Healthier lifestyle behaviors (such as diet and physical activity) would result in an immediate benefit of reduced symptoms and long-term benefit of improved health while lowering cancer risk. This randomized controlled trial tests an intervention that will help in lessening survivors' symptoms to improve adherence to the ACS guidelines for cancer prevention ultimately improving overall health.

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:

1. Increase in fruit and vegetable consumption (measured via self-reported 24-hour recall and objectively with carotenoid skin colorimetry)
2. 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.

Eligibility criteria: Inclusion criteria for female Hispanic cancer survivors:

1. 18 years of age or older;
2. have access to a telephone,
3. speak and understand English or Spanish;
4. 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;
5. 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
6. has a caregiver willing to participate in the study with them.

Inclusion criteria for the caregivers (nominated by the survivor) are:

1. age 18 or older;
2. able to speak and understand English or Spanish;
3. access to a telephone; and
4. 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:

1. Under the age of 18 years
2. Does not have access to a telephone
3. Completed treatment for cancer more than 1 year ago
4. Currently receiving counseling or treatment for special diet or weight loss
5. Does not have a caregiver willing to participate with them

Exclusion criteria for caregivers:

1. Under the age of 18 years
2. Does not have access to a telephone
3. Currently receiving counseling or treatment for special diet or weight loss
4. Currently being treated for cancer

Primary outcomes:
measure: Change in vegetable and fruit intake at 13-weeks in survivors
timeFrame: Baseline to 13-weeks
measure: Change from baseline vegetable and fruit intake at 25-weeks in survivors
timeFrame: Baseline to 25-weeks
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, 13-weeks, and 25-weeks
measure: Symptom severity
timeFrame: Baseline, 13-weeks, and 25-weeks
measure: Vegetable and fruit intake in caregivers
timeFrame: Baseline, 13-weeks, and 25-weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Jennifer Bea, PhD
role: PRINCIPAL_INVESTIGATOR
References: