SMLI With Hispanic Cancer Survivors and Caregivers

NCT05364372 | Active Not Recruiting DMC

• 1 other identifier: 35221
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivors; Cancer

Keywords

Cancer survivors; Caregivers; Symptom assessment; Lifestyle intervention; Diet; Physical activity

Outcome Measures

Primary Outcomes (2)

• Change in vegetable and fruit intake at 13-weeks in survivors

  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

  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 Outcomes (3)

• Physical activity

  Baseline, 13-weeks, and 25-weeks

• Symptom severity

  Baseline, 13-weeks, and 25-weeks

• Vegetable and fruit intake in caregivers

  Baseline, 13-weeks, and 25-weeks

Study Arms (2)

Attention control

ACTIVE COMPARATOR

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.

Behavioral: Symptom assessment only

Symptom management and lifestyle intervention

EXPERIMENTAL

Dyads will receive 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity.

Behavioral: Symptom management and lifestyle intervention

Interventions

Symptom assessment only BEHAVIORAL

Dyads will receive 12 weekly phone calls to assess symptom management.

Attention control

Symptom management and lifestyle intervention BEHAVIORAL

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.

Symptom management and lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Arizona: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer Bea, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 6, 2022
• Study Start: August 25, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)