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An Educational Intervention for Patients With Bladder Cancer

torstai 3. elokuuta 2017 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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).

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

43

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 85 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: 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.
Placebo Comparator: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Decisional Regret Scale
Aikaikkuna: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Regret Scale
Aikaikkuna: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Regret Scale
Aikaikkuna: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Regret Scale
Aikaikkuna: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Self-Efficacy Scale
Aikaikkuna: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Self-Efficacy Scale
Aikaikkuna: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Self-Efficacy Scale
Aikaikkuna: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Self-Efficacy Scale
Aikaikkuna: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Treatment-related Values
Aikaikkuna: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Treatment-related Values
Aikaikkuna: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Treatment-related Values
Aikaikkuna: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Treatment-related Values
Aikaikkuna: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Regret Scale
Aikaikkuna: Baseline

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

Baseline
Decisional Regret Scale
Aikaikkuna: 1 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

1 month follow up
Decisional Regret Scale
Aikaikkuna: 3 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

3 month follow up
Decisional Regret Scale
Aikaikkuna: 6 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

6 month follow up

Toissijaiset tulostoimenpiteet

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Sunnuntai 1. syyskuuta 2013

Ensisijainen valmistuminen (Todellinen)

Perjantai 30. kesäkuuta 2017

Opintojen valmistuminen (Todellinen)

Perjantai 30. kesäkuuta 2017

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 30. heinäkuuta 2013

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 31. heinäkuuta 2013

Ensimmäinen Lähetetty (Arvio)

Perjantai 2. elokuuta 2013

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 4. elokuuta 2017

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 3. elokuuta 2017

Viimeksi vahvistettu

Tiistai 1. elokuuta 2017

Lisää tietoa

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