Renal Cell CarcinomaNCT05418387
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
A study testing Social Support Network Intervention in people with Renal Cell Carcinoma and Hepatocellular Carcinoma, run by University of Arizona.
Trial summary
This project will develop and pilot test social support intervention for an underserved population, Hispanics in Arizona, who have high rates of kidney and liver cancer to improve health equity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma, Hepatocellular Carcinoma
- What is being tested?
- Social Support Network Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 31 Dec 2025
- 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
- Eligible participants will be adult Hispanic patients (age 18 or older) who have diagnosis of primary kidney and liver cancer through imaging assessment with CT or MRI at BUMC.
- For liver cancer, we will include only HCC patients.
Who cannot join
- Patients with a small kidney mass (clinical T1a) who are undergoing active surveillance and patients with metastatic kidney or liver cancer will be excluded.
About this study
Official title: A Pilot Social Network and Support Intervention to Improve Kidney and Liver Cancer Treatment Among Hispanics in Arizona
This project will develop and pilot test social support intervention for an underserved population, Hispanics in Arizona, who have high rates of kidney and liver cancer to improve health equity. The investigators will incorporate caregivers (family members) and other individuals in a patient's social network in survivorship, who are especially critical to quality cancer care. Caregivers provide more than half the care to cancer survivors and are often instrumental in facilitating the survivor to receive the care needed and adhere to guidelines. Through this project, the investigators will be able to leverage the resources of the Cancer Heath Equity Research Center (e.g., community outreach) to develop an intervention that has the potential for scalability and reach and recruit a sufficient sample across the target catchment area (including rural participants who may live near the US-Mexico border).
Read the detailed description
The goals of this 6-month patient navigator implemented telephone-based social support intervention are to assess 1) feasibility of a full-scale intervention in Hispanic kidney and liver cancer patients and 2) the effect of intervention on timely treatment initiation and adherence to follow-up care in (n=100). The pilot intervention in this study will determine effective recruitment and study participant retention strategies, intervention feasibility and acceptability, and best timing to initiate the intervention, length of intervention, and required sample size.
The primary outcome of this pilot intervention is to assess feasibility of a full-scale intervention study by determining: 1) how many patients are screened and enrolled per month, 2) how many enrolled patients participate in each intervention activity/assessment, 3) how well study participants complete each assessment (adherence to the intervention), and 4) what proportion of enrolled patients complete the intervention. Through this pilot study, the investigators will assess if the proposed intervention is acceptable to Hispanic kidney and liver cancer patients.
Additionally, the investigators will evaluate the effect of social support intervention on timely treatment initiation after diagnosis. Timely treatment after diagnosis will be based on time in days between cancer diagnosis with CT or MRI to initiation of definitive treatment (e.g., surgery, liver transplant, or ablation). Many kidney and liver cancer patients initiate treatment within 3 months after the diagnosis and continue to have follow-up care. Kidney cancer patients undergo an imaging assessment for other reasons and have incidental findings of a kidney mass. Adherence to follow-up care will be assessed based on whether patients schedule and show up for follow-up imaging assessment or scheduled appointments with hepatologists or urologists and how long the delay in the follow-up care is.
Intervention materials will be adapted from an existing, manualized symptom management intervention shown to be effective in reducing symptom burden in cancer survivors. Drs. Batai and Valencia will supervise the revision, translation, cultural adaptation, and illustration of the intervention to be linguistically and culturally appropriate for Spanish-speaking cancer survivors and caregivers. Intervention education materials will serve as an evidence-based guide for easy reference, including frequently asked questions, information on when to contact the health care provider (when patients have symptoms), strategies for communication with health care providers, family members and friends, and information on lifestyle modification (i.e. diet and physical activity) for cancer patients.
The results of this pilot intervention will be used to develop a larger, adequately-powered randomized controlled trial to robustly evaluate the effects of integrating existing social networks into care to reduce the negative effect of social deprivation and improve timeliness of treatment initiation and adherence to recommended treatment.
- Conditions
- Renal Cell Carcinoma, Hepatocellular Carcinoma
- Being tested
- Social Support Network Intervention, Control (Patient Navigation Service)
- Keywords
- Kidney cancer, Renal cell carcinoma, Hepatocellular carcinoma, Social support, Social network, Caregiver, Hispanics
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Hepatocellular, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Support Network InterventionBehavioural
The navigator will provide basic patient navigation services and Supportive Health Education to the patient/caregiver dyads in the patient's preferred language using the Support Network Workbook. The intervention will consist of 7 telephone sessions. There will be 2 sessions in the first month and one session per month after the first month (6 months total). Coaching and guiding techniques rather than lectures will be used applying dyads' specific social support network information. Each session will be about 30 minutes long.
Control (Patient Navigation Service)Behavioural
The patient navigator will provide basic patient navigation services consisting of health care barriers/social needs assessment, referral to social workers (if eligible) and support groups for patients and caregivers, and transportation assistance without Supportive Health Education. Patient/caregiver dyads in the control group will be contacted at 3- and 6-months post-enrollment and asked about their experience receiving treatment, any challenges they encountered or are currently facing, and the care support they received from family members, friends, CHWs, and health care providers.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients randomized to receive the Social Support Network intervention Receives: Behavioral: Social Support Network Intervention |
| Patient Navigation | Active comparator | Patients randomized to receive Usual Care (patient navigation) Receives: Behavioral: Control (Patient Navigation Service) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening and enrollment figures
Screening and enrollment figures will be assessed as the number of patients who are screened and enrolled per month, respectively.
Measured: Screening and enrollment
Study retention
Retention will be assessed as the number of patients who complete the 6-month intervention activities and assessment in both the usual care control and intervention group.
Measured: 6-months post enrollment (end of the intervention)
Completeness of data collection
Completeness of data collection will be assessed as the proportion of randomized patients who complete each study assessment, including any follow-up assessments.
Measured: 9-months post enrollment
Participant adherence to the intervention
The proportion of patients randomized to the intervention group who complete each of the 7 telephone sessions.
Measured: 6-months post enrollment (end of intervention)
Acceptability of the intervention
Patients' overall experience and satisfaction with the intervention, navigator's assessment of the overall impact of the intervention on secondary outcomes.
Measured: 9-months post enrollment
Secondary outcomes (3)
Mean and median time to treatment initiation in the control vs. intervention group
Time in days between the date of the liver or kidney cancer diagnosis (the date a CT or MRI was conducted that led to an abnormal finding) and the date of initiation of surgical treatment, liver transplant or ablation (whichever came first) in intervention compared to control group
Measured: 6-months post enrollment (end of intervention) and 12-months
Proportion of patients who attend a follow-up imaging assessment after their surgery with hepatologists or urologists in control vs. intervention group
Proportion of patients who receive the recommended post-surgical imaging (CT/MRI) assessment in intervention compared to control group
Measured: 6-months post enrollment (end of intervention), 12-months, and 18-months
Proportion of patients who attend a scheduled appointment after their surgery with hepatologists or urologists in control vs. intervention group
Proportion of patients who attend a post-operative follow-up appointment in intervention compared to control group
Measured: 6-months post enrollment (end of intervention), 12-months, and 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start30 Sep 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The study will be withdrawn as the Principal Investigator, Ken Batai, left the institution prior to study activation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- Ken Batai, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418387
- Sponsor's protocol ID
- 35185
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2022
- Last updated
- 25 Nov 2024
- 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Social Network and Support Intervention to Improve Kidney and Liver Cancer Treatment Among Hispanics in Arizona
- ClinicalTrials.gov ID
- NCT05418387
- Acronym / sponsor ID
- 35185
- Conditions
- Renal Cell Carcinoma, Hepatocellular Carcinoma
- Keywords
- Kidney cancer, Renal cell carcinoma, Hepatocellular carcinoma, Social support, Social network, Caregiver, Hispanics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study will be withdrawn as the Principal Investigator, Ken Batai, left the institution prior to study activation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jun 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.
This project will develop and pilot test social support intervention for an underserved population, Hispanics in Arizona, who have high rates of kidney and liver cancer to improve health equity. The investigators will incorporate caregivers (family members) and other individuals in a patient's social network in survivorship, who are especially critical to quality cancer care. Caregivers provide more than half the care to cancer survivors and are often instrumental in facilitating the survivor to receive the care needed and adhere to guidelines. Through this project, the investigators will be able to leverage the resources of the Cancer Heath Equity Research Center (e.g., community outreach) to develop an intervention that has the potential for scalability and reach and recruit a sufficient sample across the target catchment area (including rural participants who may live near the US-Mexico border).
Detailed description
The goals of this 6-month patient navigator implemented telephone-based social support intervention are to assess 1) feasibility of a full-scale intervention in Hispanic kidney and liver cancer patients and 2) the effect of intervention on timely treatment initiation and adherence to follow-up care in (n=100). The pilot intervention in this study will determine effective recruitment and study participant retention strategies, intervention feasibility and acceptability, and best timing to initiate the intervention, length of intervention, and required sample size.
The primary outcome of this pilot intervention is to assess feasibility of a full-scale intervention study by determining: 1) how many patients are screened and enrolled per month, 2) how many enrolled patients participate in each intervention activity/assessment, 3) how well study participants complete each assessment (adherence to the intervention), and 4) what proportion of enrolled patients complete the intervention. Through this pilot study, the investigators will assess if the proposed intervention is acceptable to Hispanic kidney and liver cancer patients.
Additionally, the investigators will evaluate the effect of social support intervention on timely treatment initiation after diagnosis. Timely treatment after diagnosis will be based on time in days between cancer diagnosis with CT or MRI to initiation of definitive treatment (e.g., surgery, liver transplant, or ablation). Many kidney and liver cancer patients initiate treatment within 3 months after the diagnosis and continue to have follow-up care. Kidney cancer patients undergo an imaging assessment for other reasons and have incidental findings of a kidney mass. Adherence to follow-up care will be assessed based on whether patients schedule and show up for follow-up imaging assessment or scheduled appointments with hepatologists or urologists and how long the delay in the follow-up care is.
Intervention materials will be adapted from an existing, manualized symptom management intervention shown to be effective in reducing symptom burden in cancer survivors. Drs. Batai and Valencia will supervise the revision, translation, cultural adaptation, and illustration of the intervention to be linguistically and culturally appropriate for Spanish-speaking cancer survivors and caregivers. Intervention education materials will serve as an evidence-based guide for easy reference, including frequently asked questions, information on when to contact the health care provider (when patients have symptoms), strategies for communication with health care providers, family members and friends, and information on lifestyle modification (i.e. diet and physical activity) for cancer patients.
The results of this pilot intervention will be used to develop a larger, adequately-powered randomized controlled trial to robustly evaluate the effects of integrating existing social networks into care to reduce the negative effect of social deprivation and improve timeliness of treatment initiation and adherence to recommended treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Social Support Network InterventionPatients randomized to receive the Social Support Network intervention |
| Patient Navigation | Active comparator | Behavioral: Control (Patient Navigation Service)Patients randomized to receive Usual Care (patient navigation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible participants will be adult Hispanic patients (age 18 or older) who have diagnosis of primary kidney and liver cancer through imaging assessment with CT or MRI at BUMC.
- For liver cancer, we will include only HCC patients.
Key exclusion criteria (1 listed)
- Patients with a small kidney mass (clinical T1a) who are undergoing active surveillance and patients with metastatic kidney or liver cancer will be excluded.
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 |
|---|---|---|
| Social Support Network InterventionThe navigator will provide basic patient navigation services and Supportive Health Education to the patient/caregiver dyads in the patient's preferred language using the Support Network Workbook. The intervention will consist of 7 telephone sessions. There will be 2 sessions in the first month and one session per month after the first month (6 months total). Coaching and guiding techniques rather than lectures will be used applying dyads' specific social support network information. Each session will be about 30 minutes long. | Behavioural | Group A |
| Control (Patient Navigation Service)The patient navigator will provide basic patient navigation services consisting of health care barriers/social needs assessment, referral to social workers (if eligible) and support groups for patients and caregivers, and transportation assistance without Supportive Health Education. Patient/caregiver dyads in the control group will be contacted at 3- and 6-months post-enrollment and asked about their experience receiving treatment, any challenges they encountered or are currently facing, and the care support they received from family members, friends, CHWs, and health care providers. | Behavioural | Patient Navigation |
Primary outcome
Screening and enrollment figures
Time frame: Screening and enrollment
Screening and enrollment figures will be assessed as the number of patients who are screened and enrolled per month, respectively.
Study retention
Time frame: 6-months post enrollment (end of the intervention)
Retention will be assessed as the number of patients who complete the 6-month intervention activities and assessment in both the usual care control and intervention group.
Completeness of data collection
Time frame: 9-months post enrollment
Completeness of data collection will be assessed as the proportion of randomized patients who complete each study assessment, including any follow-up assessments.
Participant adherence to the intervention
Time frame: 6-months post enrollment (end of intervention)
The proportion of patients randomized to the intervention group who complete each of the 7 telephone sessions.
Acceptability of the intervention
Time frame: 9-months post enrollment
Patients' overall experience and satisfaction with the intervention, navigator's assessment of the overall impact of the intervention on secondary outcomes.
3 secondary outcomes
Mean and median time to treatment initiation in the control vs. intervention group
Time frame: 6-months post enrollment (end of intervention) and 12-months
Proportion of patients who attend a follow-up imaging assessment after their surgery with hepatologists or urologists in control vs. intervention group
Time frame: 6-months post enrollment (end of intervention), 12-months, and 18-months
Proportion of patients who attend a scheduled appointment after their surgery with hepatologists or urologists in control vs. intervention group
Time frame: 6-months post enrollment (end of intervention), 12-months, and 18-months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- 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.
Ken Batai, PhD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A study testing Social Support Network Intervention in people with Renal Cell Carcinoma and Hepatocellular Carcinoma, run by University of Arizona.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Screening and enrollment figures (time frame: Screening and enrollment). The study lists 5 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 25 Nov 2024.