Cancer SurvivorsNCT05364372
SMLI With Hispanic Cancer Survivors and Caregivers
A study testing Symptom assessment only and Symptom management and lifestyle intervention in people with Cancer Survivors and Cancer, run by University of Arizona at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Survivors, Cancer
- What is being tested?
- Symptom assessment only and Symptom management and lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 17 Jun 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Show all 9Show fewer
- Does not have access to a telephone
- Currently receiving counseling or treatment for special diet or weight loss
- Currently being treated for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers
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.
Read the 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.
- Conditions
- Cancer Survivors, Cancer
- Being tested
- Symptom assessment only, Symptom management and lifestyle intervention
- Keywords
- Cancer survivors, Caregivers, Symptom assessment, Lifestyle intervention, Diet, Physical activity
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom assessment onlyBehavioural
Dyads will receive 12 weekly phone calls to assess symptom management.
Symptom management and lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Symptom management and lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 25-weeks
Secondary outcomes (3)
Physical activity
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.
Measured: Baseline, 13-weeks, and 25-weeks
Symptom severity
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.
Measured: Baseline, 13-weeks, and 25-weeks
Vegetable and fruit intake in caregivers
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.
Measured: Baseline, 13-weeks, and 25-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start25 Aug 2022
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Jennifer Bea, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364372
- Sponsor's protocol ID
- 35221
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management and Lifestyle Intervention With Hispanic Cancer Survivors and Caregivers
- ClinicalTrials.gov ID
- NCT05364372
- Acronym / sponsor ID
- 35221
- Conditions
- Cancer Survivors, Cancer
- Keywords
- Cancer survivors, Caregivers, Symptom assessment, Lifestyle intervention, Diet, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 6 May 2022 (actual)
- 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.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention control | Active comparator | Behavioral: Symptom assessment onlyDyads 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. |
| Symptom management and lifestyle intervention | Experimental | Behavioral: Symptom management and lifestyle interventionDyads will receive 12 weekly telephone-based coaching sessions, a participant educational handbook, and a pedometer for self-monitoring physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Symptom assessment onlyDyads will receive 12 weekly phone calls to assess symptom management. | Behavioural | Attention control |
| Symptom management and lifestyle interventionSurvivor 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. | Behavioural | Symptom management and lifestyle intervention |
Primary outcome
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.
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.
3 secondary outcomes
Physical activity
Time frame: Baseline, 13-weeks, and 25-weeks
Symptom severity
Time frame: Baseline, 13-weeks, and 25-weeks
Vegetable and fruit intake in caregivers
Time frame: Baseline, 13-weeks, and 25-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Bea, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom assessment only and Symptom management and lifestyle intervention in people with Cancer Survivors and Cancer, run by University of Arizona 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 31 Jul 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 vegetable and fruit intake at 13-weeks in survivors (time frame: Baseline to 13-weeks). 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 31 Jul 2026.