- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07564960
Social Optimization Study
Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The growing cancer survivorship population. This year, more than 1.77 million Americans will receive a life-altering cancer diagnosis. Fortunately, improvements in early detection and care have led to dramatic increases in survival. Over 18 million Americans or 5.4% of the total U.S. population now identify as cancer survivors with an expected growth to 26 million by 2040. Recognition of these immense changes in survival has led the National Cancer Institute (NCI) to found the Office of Cancer Survivorship (OCS) with a stated goal of "enhancing the quality and length of survival of all persons diagnosed with cancer…" Consistent with its mission, NCI/OCS is prioritizing research that improves the QOL of this growing survivorship population.
Social integration is a critical moderator. Social integration is one potential resilience factor that may be key to improving QOL among cancer survivors. Social integration, the degree of social embeddedness and strength of social ties, is amongst the most robust predictors of a broad range of mental and physical health outcomes. Robust, replicated research documents that people who are more socially integrated experience lower rates of depression, anxiety, and most forms of chronic illness and experience lower age-adjusted disease-specific and all-cause mortality. Decades of research show that interventions to provide more support including via support groups, community events, or provision of supportive persons can improve mental and physical health outcomes. At the same time, the improvements in these outcomes are modest, suggesting that not all relevant factors are accounted for.
Work from our team examining Hispanic advantages in mental and physical health via culturally moderated social integration suggest that support receptivity is a key element of social integration effectiveness. This revelation suggests that social integration is an interactive process not unlike effective neuronal communication. Neuron communication is moderated by both the adequacy of the signal and the sensitivity of the receptor. Both must be effective for transmission to take place. Social integration benefits may work the same way. While nearly all social integration interventions have focused on providing sufficient support, almost no interventions have sought to enhance support receptivity to enhance social integration effects in the context of physical health such as cancer survivorship.
The current goal is to test whether clinical interventions to optimize support receptivity lead to improvements in social integration and QOL amongst cancer survivor populations. A pilot randomized clinical trial is proposed to evaluate feasibility and acceptability of the intervention and assessment procedures, and to explore whether the intervention can improve QOL through optimizing survivors' social receptivity to determine proof-of-concept. We propose to enroll 30 long-term (> 12 months post-treatment) lung cancer survivors randomized to either a support receptivity intervention or attention-control condition. Our intervention draws on the large body of cognitive behavioral therapy (CBT) interventions to reduce social anxiety, improve social awareness, and promote social integration for a wide range of mental health conditions. The proposed 3-week, 6 session CBT intervention specifically targets cognitive awareness of prosocial cues coupled with Behavioral Activation and Social Skills Training to improve target person social engagement. Building on our ongoing, NCI-funded work on social engagement in lung cancer patients, we will use two novel in vivo sampling methods using a mobile phone platform to assess social engagement and QOL improvements: 1) recording via the Electronically Activated Recorder (EAR)17 to capture frequency of daily social interactions, and 2) repeated self-report sampling (ecological momentary assessments) where participants will be prompted to answer questions about their social engagement experiences via their personal cell phone.
The following aims are proposed:
Aim 1: Explore whether a CBT intervention targeting social receptivity can improve QOL in cancer survivors compared to an attention control condition to determine proof-of-concept. Hypothesis: We expect that the intervention will produce improvements via the targeted mechanism with sustained differences at 2 months post.
Aim 2: Explore the degree to which the CBT intervention increases objectively assessed social engagement as a putative mechanism. Hypothesis: We expect to demonstrate proof-of-concept that social engagement is malleable with implications for survivor mental and social health in alignment with NCI survivorship priorities.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Francis Morales-Lozada
- Numer telefonu: (520) 621-0563
- E-mail: fmoraleslozada@arizona.edu
Lokalizacje studiów
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Arizona
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Tucson, Arizona, Stany Zjednoczone, 85719
- Rekrutacyjny
- University of Arizona Mel and Enid Zuckerman College of Public Health
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Kontakt:
- Francis Morales-Lozada
- Numer telefonu: (520) 621-0563
- E-mail: fmoraleslozada@arizona.edu
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Główny śledczy:
- Scott Carvajal, PhD, MPH
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Pod-śledczy:
- John Ruiz, PhD
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Pod-śledczy:
- Matthias Mel, PhD
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Pod-śledczy:
- Linda Garland, MD
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Pod-śledczy:
- Rina Fox, PhD, MPH
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults (18 Years or Older)
- History of lung cancer
- at least 12 months since cancer diagnosis
- fluent in English
- able to attend virtually or in person sessions at the University of Arizona.
Exclusion Criteria:
- Less than 12 months of cancer diagnosis at time of enrollment
- undergoing treatment for mood or anxiety health issues at time of enrollment
- unable to provide informed consent.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Social support receptivity training
Participants will receive a 3-week, 6 session CBT intervention targeting cognitive awareness of prosocial cues coupled with behavioral activation and social skills training to improve target person social engagement.
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A 3-week, 6-session CBT intervention that targets cognitive awareness of prosocial cues and leverages behavioral activation and social skills training
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Aktywny komparator: Social awareness training
Participants receiving a 3-week, 6 session program designed to increase awareness of the social support already available to them.
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A 3-week, 6 session program designed to increase awareness of available social support.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Feasibility assessed by recruitment and retention rates
Ramy czasowe: Throughout the recruitment period
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Given the pilot nature of this work, the intervention/study will be deemed feasible if 20% of eligible potential participants approached enroll and 50% of enrolled participants are retained at post-intervention
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Throughout the recruitment period
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Acceptability assessed by study-specific survey after the intervention
Ramy czasowe: 3 weeks - immediately after the intervention
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The intervention/study will be deemed acceptable if, on average, participants report satisfaction with the overall program/study as ≥2 on a 0-4 scale.
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3 weeks - immediately after the intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in quality of life (QOL) using the SF-36 from baseline to immediately after the intervention.
Ramy czasowe: 3 weeks - immediately after the intervention
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Participants will complete the 36-item SF-36, which evaluates eight health domains-physical functioning, pain, vitality, social functioning, and mental health-covering physical and mental components.
Scores on each domain range from 0-100, with higher scores indicating better quality of life (QOL).
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3 weeks - immediately after the intervention
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Change in Perceived Stress using the Perceived Stress Scale (PSS) from baseline to immediately after the intervention
Ramy czasowe: 3 weeks - immediately after the intervention
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Participants will complete a 10-item PSS, which evaluates an individual's stress level.
Scores range from 0-40, with higher scores indicating higher perceived stress.
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3 weeks - immediately after the intervention
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Change in depression using the CES-D scale from baseline to immediately after the intervention
Ramy czasowe: 3 weeks - immediately after the intervention
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Participants will complete a 10-item CES-D, which evaluates an individual's self-reported symptoms of depression.
The total score is calculated by totaling all items scored after reversing the positive mood items.
Possible range for scores is 0-11 with higher scores representing greater degrees of depressed mood.
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3 weeks - immediately after the intervention
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Change in network diversity using the Berkman-Syme Social Network Index (BS-SNI) from baseline to immediately after the intervention
Ramy czasowe: 3 weeks - immediately after the intervention
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Participants will complete the BS-SNI, which assesses network diversity, and the number of people in an individual's network.
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3 weeks - immediately after the intervention
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Change in subject loneliness and social isolation using the UCLA-Loneliness Scale from baseline to immediately after the intervention
Ramy czasowe: 3 weeks - immediately after the intervention
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Participants will complete the 10-item UCLA Loneliness Scale, which measures subjective loneliness and social isolation.
Higher scores represent higher levels of loneliness.
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3 weeks - immediately after the intervention
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Change in Multidimensional Scale of Perceived Social Support (MSPSS) scores from baseline to immediately after the intervention
Ramy czasowe: 3 weeks - immediately after the intervention
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Participants will complete a 12-item MSPSS, which measures an individual's perception of support.
A sum through all scores can range from 12-84, with higher scores noting a higher perceived support.
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3 weeks - immediately after the intervention
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Scott Carvajal, PhD, MPH, University of Arizona
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00007008
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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Badania kliniczne na Social support receptivity training
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