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The FamilyStrong Pilot Randomized Trial

6. August 2026 aktualisiert von: James N Odom, University of Alabama at Birmingham

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Sally Engler, MPH
  • Telefonnummer: 205-996-7564
  • E-Mail: sengler@uab.edu

Studieren Sie die Kontaktsicherung

  • Name: J. Nicholas Odom, PhD, RN
  • Telefonnummer: 205-934-7597
  • E-Mail: dionneod@uab.edu

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35294
        • University of Alabama at Birmingham
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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:

    1. ≥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.

Exclusion Criteria:

  • 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:

    1. 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: FamilyStrong
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.
Verhalten: FamilyStrong
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.
Kein Eingriff: Usual care
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acceptability of FamilyStrong Assessed by the Theoretical Framework of Acceptability Questionnaire
Zeitfenster: 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.
24 weeks after randomization
Feasibility: FamilyStrong Intervention Completion Rate
Zeitfenster: 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.
24 weeks
Feasibility: Study Assessment Completion Rate
Zeitfenster: 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.
24 weeks
Feasibility: Caregiver Retention Rate
Zeitfenster: 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.
From randomization through the final applicable study activity, approximately 24 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Caregivers: Hospital Anxiety and Depression Scale (anxiety symptoms)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Caregivers: Hospital Anxiety and Depression Scale (depressive symptoms)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (physical health quality of life)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Caregivers: PROMIS Global Health 10 (mental health quality of life)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Caregivers: Cancer Survivors' Partners Unmet Needs Measure (CaSPUN)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (anxiety symptoms)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Patients: Hospital Anxiety and Depression Scale (depressive symptoms)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Patients: PROMIS Global Health 10 (physical quality of life)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Patients: PROMIS Global Health 10 (mental health quality of life)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks
Patients: Cancer Survivors' Unmet Needs Measure (CaSUN)
Zeitfenster: Baseline and 24 weeks
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.
Baseline and 24 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Alabama at Birmingham

Mitarbeiter

American Cancer Society, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Januar 2027

Primärer Abschluss (Geschätzt)

31. März 2028

Studienabschluss (Geschätzt)

30. September 2028

Studienanmeldedaten

Zuerst eingereicht

6. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. August 2026

Zuerst gepostet (Tatsächlich)

13. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • IRB-300017196
  • DBG-26-1598921-01-CTPS-W25 (Andere Zuschuss-/Finanzierungsnummer: American Cancer Society)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

Data will become available beginning approximately 12 months after publication of the primary study findings and will remain available for at least 5 years.

IPD-Sharing-Zugriffskriterien

Requests will be reviewed by the Principal Investigator and appropriate UAB research officials. Access may be provided to qualified researchers whose proposed analyses have a scientifically sound purpose and are consistent with participant consent and applicable regulatory, institutional, and sponsor requirements. Approved requestors must execute a data-use agreement and agree to protect confidentiality, use the data only for the approved purpose, and not attempt to identify participants.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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