Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

An Educational Intervention for Patients With Bladder Cancer

3 août 2017 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Réel)

43

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Comparateur 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Decisional Regret Scale
Délai: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Regret Scale
Délai: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Regret Scale
Délai: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Regret Scale
Délai: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Self-Efficacy Scale
Délai: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Decisional Self-Efficacy Scale
Délai: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Decisional Self-Efficacy Scale
Délai: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Decisional Self-Efficacy Scale
Délai: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Treatment-related Values
Délai: Baseline
The intervention is designed to enhance treatment decision making.
Baseline
Treatment-related Values
Délai: 1 month follow up
The intervention is designed to enhance treatment decision making.
1 month follow up
Treatment-related Values
Délai: 3 month follow up
The intervention is designed to enhance treatment decision making.
3 month follow up
Treatment-related Values
Délai: 6 month follow up
The intervention is designed to enhance treatment decision making.
6 month follow up
Decisional Regret Scale
Délai: Baseline

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

Baseline
Decisional Regret Scale
Délai: 1 month follow up

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

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

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

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

Bladder Cancer knowledge Scale

The intervention is designed to enhance treatment decision making.

6 month follow up

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
quality of life
Délai: Baseline
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
Baseline
quality of life
Délai: 1 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
1 month follow up
quality of life
Délai: 3 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
3 month follow up
quality of life
Délai: 6 month follow up
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
6 month follow up
post-surgical self-care
Délai: Baseline
FACT-BL Ca additional concern
Baseline
post-surgical self-care
Délai: 1 month follow up
FACT-BL Ca additional concern
1 month follow up
post-surgical self-care
Délai: 3 month follow up
FACT-BL Ca additional concern
3 month follow up
post-surgical self-care
Délai: 6 month follow up
FACT-BL Ca additional concern
6 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Délai: Baseline
Baseline
CES-D scale Illness Perception Questionnaire (IPQ)
Délai: 1 month follow up
1 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Délai: 3 month follow up
3 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Délai: 6 month follow up
6 month follow up
Cancer worries scale
Délai: Baseline
Baseline
Cancer worries scale
Délai: 1 month follow up
1 month follow up
Cancer worries scale
Délai: 3 month follow up
3 month follow up
Cancer worries scale
Délai: 6 month follow up
6 month follow up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2013

Achèvement primaire (Réel)

30 juin 2017

Achèvement de l'étude (Réel)

30 juin 2017

Dates d'inscription aux études

Première soumission

30 juillet 2013

Première soumission répondant aux critères de contrôle qualité

31 juillet 2013

Première publication (Estimation)

2 août 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner