Family CaregiversNCT07761988
The FamilyStrong Pilot Randomized Trial
A study testing FamilyStrong in people with Family Caregivers and Distress in Caregivers of Cancer Patients, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
When someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Caregivers, Distress in Caregivers of Cancer Patients, Advanced Cancer
- What is being tested?
- FamilyStrong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAREGIVERS:
- 1) ≥18 years of age; 2) self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists with your health and medical care and who may or may not live in the same residence as you and who is not paid for their help"; 3) caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below) who is not enrolled in hospice; 4) caregivers will NOT need to have a patient willing to participate; and 5) able to speak and read English and complete baseline measures.
- PATIENTS:
- ≥18 years of age; 2) screened within 60 days of an oncology visit where the patient had documentation of a new diagnosis of an advanced stage cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma; and hematologic malignancies; and 3) able to speak and read English and complete baseline measures.
Who cannot join
- CAREGIVERS:
- 1) Self-reported active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.
- PATIENTS:
- Receiving hospice per EHR; 2) Per EHR, active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, suicidal ideation, uncorrected hearing loss, or substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
James N Odom, PhD, RN, 2059347597, dionneod@uab.edu
Sally Engler, MPH, 205-996-7564, sengler@uab.edu
About this study
Official title: Brief Distress Support for Family Caregivers of Persons With Advanced Cancer: The FamilyStrong Pilot Randomized Trial
When someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. This responsibility can take a significant toll, leaving family caregivers overwhelmed, highly stressed, and without access to the support they need. Research shows that when caregivers are struggling, both they and the patients they care for suffer. Caregiver distress has been linked to poor quality of life for patients and greater emotional strain on families. Despite the well-documented emotional and physical burdens on family caregivers, most cancer centers do not include structured support services to help them cope and navigate challenges. Many caregivers do not even realize help is available, leading to feelings of isolation and burnout. Yet, despite the critical role caregivers play in cancer care, there are very few programs designed to support them in ways that are both effective and widely accessible. To address this urgent need, our team has developed FamilyStrong, a novel intervention specifically designed to fill this gap and support family caregivers in real-world cancer care settings. FamilyStrong is a brief and easy-to-use program that helps family caregivers recognize and manage distress while connecting them to the right support. Unlike many caregiver support programs that require extensive time and highly trained specialists, FamilyStrong is led by lay navigators, who are trained individuals who can guide caregivers through challenges and connect them with appropriate resources. The program uses a simple distress screening tool to quickly assess how caregivers are coping and then tailors support to their specific needs. We will test FamilyStrong in a small pilot study with 60 caregivers of patients newly diagnosed with advanced cancer. Over a period of 24 weeks, we will evaluate how well the program works, whether caregivers find it helpful, and whether it improves caregiver and patient well-being compared to usual care. Specifically, we will measure whether caregivers experience lower stress, improved quality of life, and fewer unmet needs when they participate in the FamilyStrong program. After this study, we will use these results and our experiences to inform a larger clinical trial to confirm FamilyStrong's benefits and eventually expand the program nationwide. By providing caregivers with practical, effective support, FamilyStrong has the potential to improve the quality of life for both caregivers and cancer patients, ensuring that families facing cancer receive the help they need when they need it most.
Read the detailed description
This is a single-site, two-arm, parallel-group, NIH Stage IB pilot randomized clinical trial evaluating FamilyStrong, a brief caregiver distress-screening and support intervention. Sixty adult family caregivers of people with advanced cancer will be randomized 1:1 to FamilyStrong or usual care. The caregiver is the unit of randomization and the direct recipient of the intervention. Up to 60 patients may also participate in research data collection, but patient participation is optional and patients do not receive the FamilyStrong intervention.
Caregivers assigned to FamilyStrong will receive approximately monthly telephone contacts for 24 weeks from a trained lay navigator. During each contact, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and caregiver-specific Problem List, identify the caregiver's highest-priority concerns and desired assistance, and provide individualized support. Support may include emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral to appropriate clinical or community services. Caregivers may accept, decline, or postpone any offered assistance.
FamilyStrong caregivers will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing monthly check-in pages, caregiving resources, medical and appointment organizers, problem-solving and action-planning tools, and space for notes. Caregivers assigned to usual care will continue to use services ordinarily available through the cancer center and community. Participants in both groups will receive information about available cancer-center and family-support resources.
Study assessments will occur at baseline and approximately 24 weeks. Intervention-group caregivers will also be invited to complete a post-intervention qualitative interview about their experience with FamilyStrong and the study procedures. As a pilot trial, the study is designed primarily to evaluate acceptability, feasibility, intervention delivery, and the practicality of trial procedures, while estimating preliminary between-group effects to inform a future, larger efficacy trial. It is not powered to provide a definitive test of intervention effectiveness.
- Being tested
- FamilyStrong
- Keywords
- family caregiver, cancer caregiving, caregiver support, distress screening, lay navigation, supportive care, psychosocial support, telehealth, unmet supportive care needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamilyStrongBehavioural
Caregivers randomized to FamilyStrong will receive approximately monthly telephone-based distress screening and individualized support from a trained lay navigator for 24 weeks. During each encounter, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and Problem List, identify the caregiver's priority concerns and desired assistance, and provide support as appropriate, including emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral. Participants will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing check-in pages, caregiving resources, medical and appointment organizers, worksheets, and notes pages. Additional follow-up contacts may occur based on caregiver needs.
| Study group | Role | What they receive |
|---|---|---|
| FamilyStrong | Experimental | Caregivers randomized to FamilyStrong will receive approximately monthly telephone-based distress screening and individualized support from a trained lay navigator for 24 weeks. During each encounter, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and Problem List, identify the caregiver's priority concerns and desired assistance, and provide support as appropriate, including emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral. Participants will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing check-in pages, caregiving resources, medical and appointment organizers, worksheets, and notes pages. Additional follow-up contacts may occur based on caregiver needs. Receives: Behavioral: FamilyStrong |
| Usual care | No intervention | Caregivers randomized to usual care will continue to use the supportive services ordinarily available through the UAB cancer center, health system, community organizations, and their personal support networks. The study will not restrict access to social work, chaplaincy, behavioral health, palliative care, patient navigation, support groups, or other services. Participants will receive a study-approved packet describing available cancer-center and family-support resources but will not receive the monthly FamilyStrong navigator contacts during the 24-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of FamilyStrong Assessed by the Theoretical Framework of Acceptability Questionnaire
Intervention-group caregivers will complete the Theoretical Framework of Acceptability questionnaire, which assesses affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. The outcome will be the mean questionnaire score. A mean score of at least 4 is the prespecified benchmark indicating acceptable intervention delivery.
Measured: 24 weeks after randomization
Feasibility: FamilyStrong Intervention Completion Rate
Percentage of eligible, scheduled FamilyStrong encounters completed by intervention-group caregivers. A completed encounter includes administration of the Caregiver Distress Thermometer, Problem List, "Bothers Most," and "Would Like Assistance With" questions, with individualized support provided as indicated. Encounters scheduled after withdrawal or patient death are excluded from the denominator. The feasibility benchmark is at least 80% completion.
Measured: 24 weeks
Feasibility: Study Assessment Completion Rate
Percentage of baseline and 24-week study assessments completed by eligible caregiver and optional patient participants. Assessments not administered because of patient death or withdrawal will be reported separately and will not be counted as incomplete. The prespecified feasibility benchmark is at least 80% completion.
Measured: 24 weeks
Feasibility: Caregiver Retention Rate
Percentage of randomized caregiver participants who remain enrolled through completion of their final protocol-applicable study activity. Caregivers whose patient dies before week 24 will not be considered lost solely because the week-24 quantitative assessment is not administered.
Measured: From randomization through the final applicable study activity, approximately 24 weeks
Secondary outcomes (10)
Caregivers: Hospital Anxiety and Depression Scale (anxiety symptoms)
Caregiver anxiety symptoms will be measured using the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale. Subscale scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. The outcome is the change in score from baseline to 24 weeks after randomization.
Measured: Baseline and 24 weeks
Caregivers: Hospital Anxiety and Depression Scale (depressive symptoms)
Caregiver depressive symptoms will be measured using the seven-item depression subscale of the Hospital Anxiety and Depression Scale. Higher scores indicate greater depressive symptoms. The outcome is the change in depression subscale score from baseline to 24 weeks after randomization.
Measured: Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (physical health quality of life)
Caregiver physical health-related quality of life will be measured using the physical health score from the 10-item PROMIS Global Health measure. Higher scores indicate better physical health-related quality of life. The outcome is the change in score from baseline to 24 weeks after randomization.
Measured: Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (mental health quality of life)
Caregiver mental health-related quality of life will be measured using the mental health score from the 10-item PROMIS Global Health measure. Higher scores indicate better mental health-related quality of life.
Measured: Baseline and 24 weeks
Caregivers: Cancer Survivors' Partners Unmet Needs Measure (CaSPUN)
Caregiver unmet supportive care needs will be measured using the 35-item Cancer Survivors' Partners Unmet Needs Measure (CaSPUN). The measure assesses unmet needs across information, quality of life, emotional and relationship, and life-perspective domains. Higher scores indicate greater unmet needs.
Measured: Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (anxiety symptoms)
Anxiety symptoms among optional patient participants will be measured using the seven-item anxiety subscale of the Hospital Anxiety and Depression Scale. Higher scores indicate greater anxiety symptoms.
Measured: Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (depressive symptoms)
Depressive symptoms among optional patient participants will be measured using the seven-item depression subscale of the Hospital Anxiety and Depression Scale. Higher scores indicate greater depressive symptoms.
Measured: Baseline and 24 weeks
Patients: PROMIS Global Health 10 (physical quality of life)
Physical health-related quality of life among optional patient participants will be measured using the physical health score from the 10-item PROMIS Global Health measure. Higher scores indicate better physical health-related quality of life.
Measured: Baseline and 24 weeks
Patients: PROMIS Global Health 10 (mental health quality of life)
Mental health-related quality of life among optional patient participants will be measured using the mental health score from the 10-item PROMIS Global Health measure. Higher scores indicate better mental health-related quality of life.
Measured: Baseline and 24 weeks
Patients: Cancer Survivors' Unmet Needs Measure (CaSUN)
Unmet supportive care needs among optional patient participants will be measured using the 35-item adapted Cancer Survivors' Unmet Needs Measure (CaSUN). The measure assesses needs related to information and medical care, quality of life, emotional and relationship concerns, and life perspective. Higher scores indicate greater unmet needs.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, James N Odom, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761988
- Sponsor's protocol ID
- IRB-300017196
- Other IDs
- DBG-26-1598921-01-CTPS-W25
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary published results may be shared with qualified researchers following completion of the primary analyses and publication. Shared data may include quantitative caregiver and patient questionnaire data and relevant intervention-process data, together with a data dictionary. Audio recordings, direct identifiers, and data presenting an unreasonable risk of participant re-identification will not be shared. Access will require an approved research proposal, execution of a data-use agreement, and applicable UAB, Institutional Review Board, sponsor, and participant-consent requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Distress Support for Family Caregivers of Persons With Advanced Cancer: The FamilyStrong Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT07761988
- Acronym / sponsor ID
- IRB-300017196
- Keywords
- family caregiver, cancer caregiving, caregiver support, distress screening, lay navigation, supportive care, psychosocial support, telehealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 13 Aug 2026 (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.
When someone is diagnosed with advanced cancer, their family members and close friends often take on the role of caregiver, providing emotional support and complex medical care for their loved one, often for up to eight hours a day. This responsibility can take a significant toll, leaving family caregivers overwhelmed, highly stressed, and without access to the support they need. Research shows that when caregivers are struggling, both they and the patients they care for suffer. Caregiver distress has been linked to poor quality of life for patients and greater emotional strain on families. Despite the well-documented emotional and physical burdens on family caregivers, most cancer centers do not include structured support services to help them cope and navigate challenges. Many caregivers do not even realize help is available, leading to feelings of isolation and burnout. Yet, despite the critical role caregivers play in cancer care, there are very few programs designed to support them in ways that are both effective and widely accessible. To address this urgent need, our team has developed FamilyStrong, a novel intervention specifically designed to fill this gap and support family caregivers in real-world cancer care settings. FamilyStrong is a brief and easy-to-use program that helps family caregivers recognize and manage distress while connecting them to the right support. Unlike many caregiver support programs that require extensive time and highly trained specialists, FamilyStrong is led by lay navigators, who are trained individuals who can guide caregivers through challenges and connect them with appropriate resources. The program uses a simple distress screening tool to quickly assess how caregivers are coping and then tailors support to their specific needs. We will test FamilyStrong in a small pilot study with 60 caregivers of patients newly diagnosed with advanced cancer. Over a period of 24 weeks, we will evaluate how well the program works, whether caregivers find it helpful, and whether it improves caregiver and patient well-being compared to usual care. Specifically, we will measure whether caregivers experience lower stress, improved quality of life, and fewer unmet needs when they participate in the FamilyStrong program. After this study, we will use these results and our experiences to inform a larger clinical trial to confirm FamilyStrong's benefits and eventually expand the program nationwide. By providing caregivers with practical, effective support, FamilyStrong has the potential to improve the quality of life for both caregivers and cancer patients, ensuring that families facing cancer receive the help they need when they need it most.
Detailed description
This is a single-site, two-arm, parallel-group, NIH Stage IB pilot randomized clinical trial evaluating FamilyStrong, a brief caregiver distress-screening and support intervention. Sixty adult family caregivers of people with advanced cancer will be randomized 1:1 to FamilyStrong or usual care. The caregiver is the unit of randomization and the direct recipient of the intervention. Up to 60 patients may also participate in research data collection, but patient participation is optional and patients do not receive the FamilyStrong intervention.
Caregivers assigned to FamilyStrong will receive approximately monthly telephone contacts for 24 weeks from a trained lay navigator. During each contact, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and caregiver-specific Problem List, identify the caregiver's highest-priority concerns and desired assistance, and provide individualized support. Support may include emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral to appropriate clinical or community services. Caregivers may accept, decline, or postpone any offered assistance.
FamilyStrong caregivers will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing monthly check-in pages, caregiving resources, medical and appointment organizers, problem-solving and action-planning tools, and space for notes. Caregivers assigned to usual care will continue to use services ordinarily available through the cancer center and community. Participants in both groups will receive information about available cancer-center and family-support resources.
Study assessments will occur at baseline and approximately 24 weeks. Intervention-group caregivers will also be invited to complete a post-intervention qualitative interview about their experience with FamilyStrong and the study procedures. As a pilot trial, the study is designed primarily to evaluate acceptability, feasibility, intervention delivery, and the practicality of trial procedures, while estimating preliminary between-group effects to inform a future, larger efficacy trial. It is not powered to provide a definitive test of intervention effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FamilyStrong | Experimental | Behavioral: FamilyStrongCaregivers randomized to FamilyStrong will receive approximately monthly telephone-based distress screening and individualized support from a trained lay navigator for 24 weeks. During each encounter, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and Problem List, identify the caregiver's priority concerns and desired assistance, and provide support as appropriate, including emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral. Participants will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing check-in pages, caregiving resources, medical and appointment organizers, worksheets, and notes pages. Additional follow-up contacts may occur based on caregiver needs. |
| Usual care | No intervention | –Caregivers randomized to usual care will continue to use the supportive services ordinarily available through the UAB cancer center, health system, community organizations, and their personal support networks. The study will not restrict access to social work, chaplaincy, behavioral health, palliative care, patient navigation, support groups, or other services. Participants will receive a study-approved packet describing available cancer-center and family-support resources but will not receive the monthly FamilyStrong navigator contacts during the 24-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CAREGIVERS:
- 1) ≥18 years of age; 2) self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists with your health and medical care and who may or may not live in the same residence as you and who is not paid for their help"; 3) caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below) who is not enrolled in hospice; 4) caregivers will NOT need to have a patient willing to participate; and 5) able to speak and read English and complete baseline measures.
- PATIENTS:
Key exclusion criteria (4 listed)
- CAREGIVERS:
- 1) Self-reported active, untreated mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.
- PATIENTS:
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 |
|---|---|---|
| FamilyStrongCaregivers randomized to FamilyStrong will receive approximately monthly telephone-based distress screening and individualized support from a trained lay navigator for 24 weeks. During each encounter, the navigator will administer the FamilyStrong Caregiver Distress Thermometer and Problem List, identify the caregiver's priority concerns and desired assistance, and provide support as appropriate, including emotional support, information and education, collaborative problem-solving, action planning, resource navigation, consultation, or referral. Participants will also receive the FamilyStrong Navigation Companion, a caregiver-directed resource containing check-in pages, caregiving resources, medical and appointment organizers, worksheets, and notes pages. Additional follow-up contacts may occur based on caregiver needs. | Behavioural | FamilyStrong |
Primary outcome
Acceptability of FamilyStrong Assessed by the Theoretical Framework of Acceptability Questionnaire
Time frame: 24 weeks after randomization
Intervention-group caregivers will complete the Theoretical Framework of Acceptability questionnaire, which assesses affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. The outcome will be the mean questionnaire score. A mean score of at least 4 is the prespecified benchmark indicating acceptable intervention delivery.
Feasibility: FamilyStrong Intervention Completion Rate
Time frame: 24 weeks
Percentage of eligible, scheduled FamilyStrong encounters completed by intervention-group caregivers. A completed encounter includes administration of the Caregiver Distress Thermometer, Problem List, "Bothers Most," and "Would Like Assistance With" questions, with individualized support provided as indicated. Encounters scheduled after withdrawal or patient death are excluded from the denominator. The feasibility benchmark is at least 80% completion.
Feasibility: Study Assessment Completion Rate
Time frame: 24 weeks
Percentage of baseline and 24-week study assessments completed by eligible caregiver and optional patient participants. Assessments not administered because of patient death or withdrawal will be reported separately and will not be counted as incomplete. The prespecified feasibility benchmark is at least 80% completion.
Feasibility: Caregiver Retention Rate
Time frame: From randomization through the final applicable study activity, approximately 24 weeks
Percentage of randomized caregiver participants who remain enrolled through completion of their final protocol-applicable study activity. Caregivers whose patient dies before week 24 will not be considered lost solely because the week-24 quantitative assessment is not administered.
10 secondary outcomes
Caregivers: Hospital Anxiety and Depression Scale (anxiety symptoms)
Time frame: Baseline and 24 weeks
Caregivers: Hospital Anxiety and Depression Scale (depressive symptoms)
Time frame: Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (physical health quality of life)
Time frame: Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (mental health quality of life)
Time frame: Baseline and 24 weeks
Caregivers: Cancer Survivors' Partners Unmet Needs Measure (CaSPUN)
Time frame: Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (anxiety symptoms)
Time frame: Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (depressive symptoms)
Time frame: Baseline and 24 weeks
Patients: PROMIS Global Health 10 (physical quality of life)
Time frame: Baseline and 24 weeks
Patients: PROMIS Global Health 10 (mental health quality of life)
Time frame: Baseline and 24 weeks
Patients: Cancer Survivors' Unmet Needs Measure (CaSUN)
Time frame: Baseline and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary published results may be shared with qualified researchers following completion of the primary analyses and publication. Shared data may include quantitative caregiver and patient questionnaire data and relevant intervention-process data, together with a data dictionary. Audio recordings, direct identifiers, and data presenting an unreasonable risk of participant re-identification will not be shared. Access will require an approved research proposal, execution of a data-use agreement, and applicable UAB, Institutional Review Board, sponsor, and participant-consent requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FamilyStrong in people with Family Caregivers and Distress in Caregivers of Cancer Patients, run by University of Alabama at Birmingham 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. Nicholas Odom, PhD, RN (205-934-7597, dionneod@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of FamilyStrong Assessed by the Theoretical Framework of Acceptability Questionnaire (time frame: 24 weeks after randomization). The study lists 4 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 13 Aug 2026.