- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01915121
An Educational Intervention for Patients With Bladder Cancer
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
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The Bronx, New York, Forenede Stater, 10468
- James J. Peters VA Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv 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.
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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.
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Placebo komparator: Nutrition Intervention
In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Decisional Regret Scale
Tidsramme: Baseline
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The intervention is designed to enhance treatment decision making.
|
Baseline
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Decisional Regret Scale
Tidsramme: 1 month follow up
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The intervention is designed to enhance treatment decision making.
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1 month follow up
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Decisional Regret Scale
Tidsramme: 3 month follow up
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The intervention is designed to enhance treatment decision making.
|
3 month follow up
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Decisional Regret Scale
Tidsramme: 6 month follow up
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The intervention is designed to enhance treatment decision making.
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6 month follow up
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Decisional Self-Efficacy Scale
Tidsramme: Baseline
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The intervention is designed to enhance treatment decision making.
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Baseline
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Decisional Self-Efficacy Scale
Tidsramme: 1 month follow up
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The intervention is designed to enhance treatment decision making.
|
1 month follow up
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Decisional Self-Efficacy Scale
Tidsramme: 3 month follow up
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The intervention is designed to enhance treatment decision making.
|
3 month follow up
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Decisional Self-Efficacy Scale
Tidsramme: 6 month follow up
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The intervention is designed to enhance treatment decision making.
|
6 month follow up
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Treatment-related Values
Tidsramme: Baseline
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The intervention is designed to enhance treatment decision making.
|
Baseline
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Treatment-related Values
Tidsramme: 1 month follow up
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The intervention is designed to enhance treatment decision making.
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1 month follow up
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Treatment-related Values
Tidsramme: 3 month follow up
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The intervention is designed to enhance treatment decision making.
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3 month follow up
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Treatment-related Values
Tidsramme: 6 month follow up
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The intervention is designed to enhance treatment decision making.
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6 month follow up
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Decisional Regret Scale
Tidsramme: Baseline
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
Baseline
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Decisional Regret Scale
Tidsramme: 1 month follow up
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
1 month follow up
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Decisional Regret Scale
Tidsramme: 3 month follow up
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
3 month follow up
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Decisional Regret Scale
Tidsramme: 6 month follow up
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Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making. |
6 month follow up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
quality of life
Tidsramme: Baseline
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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Baseline
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quality of life
Tidsramme: 1 month follow up
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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1 month follow up
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quality of life
Tidsramme: 3 month follow up
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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3 month follow up
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quality of life
Tidsramme: 6 month follow up
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FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
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6 month follow up
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post-surgical self-care
Tidsramme: Baseline
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FACT-BL Ca additional concern
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Baseline
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post-surgical self-care
Tidsramme: 1 month follow up
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FACT-BL Ca additional concern
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1 month follow up
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post-surgical self-care
Tidsramme: 3 month follow up
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FACT-BL Ca additional concern
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3 month follow up
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post-surgical self-care
Tidsramme: 6 month follow up
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FACT-BL Ca additional concern
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6 month follow up
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CES-D scale Illness Perception Questionnaire (IPQ)
Tidsramme: Baseline
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Baseline
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CES-D scale Illness Perception Questionnaire (IPQ)
Tidsramme: 1 month follow up
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1 month follow up
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CES-D scale Illness Perception Questionnaire (IPQ)
Tidsramme: 3 month follow up
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3 month follow up
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CES-D scale Illness Perception Questionnaire (IPQ)
Tidsramme: 6 month follow up
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6 month follow up
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Cancer worries scale
Tidsramme: Baseline
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Baseline
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Cancer worries scale
Tidsramme: 1 month follow up
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1 month follow up
|
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Cancer worries scale
Tidsramme: 3 month follow up
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3 month follow up
|
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Cancer worries scale
Tidsramme: 6 month follow up
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6 month follow up
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Nihal E Mohamed, PhD, Icahn School of Medicine at Mount Sinai
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 09-0479
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