Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

An Educational Intervention for Patients With Bladder Cancer

3 sierpnia 2017 zaktualizowane przez: Icahn School of Medicine at Mount Sinai

An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society

The study main objectives are to enhance treatment decision making and improve quality of life and post-treatment health care among patients diagnosed with invasive bladder cancer.

Bladder cancer (BL Ca) is the 5th most commonly diagnosed cancer in the US . BL Ca is more common among men than women and 90% of all patients are over the age of 55. Surgery to remove the bladder followed by one of three diversion techniques (i.e., ileal conduit, continent reservoir, and neobladder) is the standard therapy following invasive bladder cancer. The emotional, functional, physical, and social impact of invasive Bl Ca treatment on patients' QOL and adjustment can be devastating. This impact significantly varies by treatment option. Treatment decision making in for BL Ca is difficult at best and potentially susceptible to a number of cognitive and affective factors (e.g., patients' emotional reaction, values, and expectations). Thus, in addition to adjusting to a potential life-threatening disease, having to cope with uncertainty about the efficacy and outcomes of different treatment options adds to the overall distress and may impair effective decision-making. In spite of increasing efforts in health communication and patient education, no study has examined treatment decision making among invasive bladder patients or has provided an educational intervention to facilitate treatment decision making among this population. To this end, and guided by the Self-Regulation theory (SRT) that emphasizes the role of cognitive and emotional factors in decision making, we have designed and pilot tested the acceptability of a preliminary educational and training experiential intervention (ETE) to address this gap in the literature. The ETE intervention uses new and innovative educational strategies and methods to educate patients about their treatment options and to facilitate their treatment decision making.

Przegląd badań

Szczegółowy opis

The goals of the study are: 1) to further enhance the design and application of the ETE intervention, and 2) to provide data on the efficacy of the refined ETE intervention in a randomized-controlled study (RCT). To achieve these 2 goals, the study is divided in to 2 phases.

PHASE 1: To enhance and refine the design and application of the preliminary ETE intervention:

Aim 1-a: To explore knowledge, beliefs, values and expectations about treatment options, treatment decision making, and quality of life (QOL) among patients with BL Ca.

To achieve Aim 1-a of Phase 1, as a first step, 2 focus groups (FG; N = 10 each) of invasive BL Ca patients will be conducted to a) examine knowledge, beliefs, values, expectations, and affective responses about treatment options and treatment decision making, b) record difficulties and problems in post-surgical health care (e.g., using stoma appliances and catheters), and c) explore concerns patients have as they live with the impact of treatment. The ETE intervention will be refined based on FG results.

Aim 1-b: To explore patients' acceptability of the refined ETE intervention. To achieve Aim 1-b of Phase 1, additional 2 FG (FG; N = 10 each) of BL Ca survivors will be conducted to solicit input about the design and acceptability of the refined ETE intervention.

PHASE 2: Aim 2. To assess the efficacy of the ETE intervention in small RCT To achieve Aim 2 of Phase 2, a two-group RCT (standard care (SC) plus time and attention control condition, N = 62 patients; SC plus ETE intervention N = 62 patients) will be conducted to examine the efficacy of the ETE intervention. Phase 2 will provide a) a test of the efficacy of the refined ETE intervention for reducing decisional conflict and regret, and improving QOL and post-treatment stoma and pouch care controlling for potential clinical and socio-demographic covariates (e.g., treatment type, age).

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

43

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • New York
      • New York, New York, Stany Zjednoczone, 10029
        • Icahn School of Medicine at Mount Sinai
      • The Bronx, New York, Stany Zjednoczone, 10468
        • James J. Peters VA Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 85 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Phase 1 (Focus groups/ In-depth Interview)

Inclusion Criteria:

  • treatment of invasive Bladder Cancer a with cystectomy and one of the three major urinary diversion methods
  • English speaking
  • between the ages of 18 and 85
  • able and willing to provide informed consent
  • may have received neoadjuvant or adjuvant chemotherapy, radiation therapy, and immunotherapy (BCG)

Exclusion Criteria:

  • metastatic disease or cancer recurrence
  • presence of other primary cancers
  • no access to a telephone

Phase 2 (randomized-controlled-study)

Additional Exclusion Criteria:

- treatment decision is made and /beginning/completion of treatment.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Education Intervention
In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer.
1-hour educational and training sessions. In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.
Komparator placebo: Nutrition Intervention
In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery
1-hour educational and training sessions. In this session, participant will be provided with nutrition information directly related to Bladder Cancer recovery. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Decisional Regret Scale
Ramy czasowe: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Regret Scale
Ramy czasowe: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Regret Scale
Ramy czasowe: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Regret Scale
Ramy czasowe: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Self-Efficacy Scale
Ramy czasowe: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Self-Efficacy Scale
Ramy czasowe: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Self-Efficacy Scale
Ramy czasowe: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Self-Efficacy Scale
Ramy czasowe: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Treatment-related Values
Ramy czasowe: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Treatment-related Values
Ramy czasowe: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Treatment-related Values
Ramy czasowe: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Treatment-related Values
Ramy czasowe: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Regret Scale
Ramy czasowe: Baseline

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

Baseline
Decisional Regret Scale
Ramy czasowe: 1 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

1 month follow up
Decisional Regret Scale
Ramy czasowe: 3 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

3 month follow up
Decisional Regret Scale
Ramy czasowe: 6 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

6 month follow up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
quality of life
Ramy czasowe: Baseline
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
Baseline
quality of life
Ramy czasowe: 1 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
1 month follow up
quality of life
Ramy czasowe: 3 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
3 month follow up
quality of life
Ramy czasowe: 6 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
6 month follow up
post-surgical self-care
Ramy czasowe: Baseline
FACT-BL Ca additional concern
Baseline
post-surgical self-care
Ramy czasowe: 1 month follow up
FACT-BL Ca additional concern
1 month follow up
post-surgical self-care
Ramy czasowe: 3 month follow up
FACT-BL Ca additional concern
3 month follow up
post-surgical self-care
Ramy czasowe: 6 month follow up
FACT-BL Ca additional concern
6 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Ramy czasowe: Baseline
Baseline
CES-D scale Illness Perception Questionnaire (IPQ)
Ramy czasowe: 1 month follow up
1 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Ramy czasowe: 3 month follow up
3 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Ramy czasowe: 6 month follow up
6 month follow up
Cancer worries scale
Ramy czasowe: Baseline
Baseline
Cancer worries scale
Ramy czasowe: 1 month follow up
1 month follow up
Cancer worries scale
Ramy czasowe: 3 month follow up
3 month follow up
Cancer worries scale
Ramy czasowe: 6 month follow up
6 month follow up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Nihal E Mohamed, PhD, Icahn School of Medicine at Mount Sinai

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2013

Zakończenie podstawowe (Rzeczywisty)

30 czerwca 2017

Ukończenie studiów (Rzeczywisty)

30 czerwca 2017

Daty rejestracji na studia

Pierwszy przesłany

30 lipca 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 lipca 2013

Pierwszy wysłany (Oszacować)

2 sierpnia 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 sierpnia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 sierpnia 2017

Ostatnia weryfikacja

1 sierpnia 2017

Więcej informacji

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 .

Subskrybuj