Bladder CancerNCT01915121
An Educational Intervention for Patients With Bladder Cancer
A study testing Education Intervention and Nutrition Intervention in people with Bladder Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Education Intervention and Nutrition Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Bladder Cancer
- Being tested
- Education Intervention, Nutrition Intervention
- Keywords
- Bladder Cancer, Intervention, Education, Randomized Controlled Trials
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionBehavioural
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.
Nutrition InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education Intervention | Active comparator | In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. Receives: Behavioral: Education Intervention |
| Nutrition Intervention | Placebo comparator | In this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery Receives: Behavioral: Nutrition Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
Measured: Baseline
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
Measured: 1 month follow up
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
Measured: 3 month follow up
Decisional Regret Scale
The intervention is designed to enhance treatment decision making.
Measured: 6 month follow up
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
Measured: Baseline
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
Measured: 1 month follow up
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
Measured: 3 month follow up
Decisional Self-Efficacy Scale
The intervention is designed to enhance treatment decision making.
Measured: 6 month follow up
Treatment-related Values
The intervention is designed to enhance treatment decision making.
Measured: Baseline
Treatment-related Values
The intervention is designed to enhance treatment decision making.
Measured: 1 month follow up
Treatment-related Values
The intervention is designed to enhance treatment decision making.
Measured: 3 month follow up
Treatment-related Values
The intervention is designed to enhance treatment decision making.
Measured: 6 month follow up
Decisional Regret Scale
Bladder Cancer knowledge Scale
The intervention is designed to enhance treatment decision making.
Measured: Baseline
Decisional Regret Scale
Bladder Cancer knowledge Scale
The intervention is designed to enhance treatment decision making.
Measured: 1 month follow up
Decisional Regret Scale
Bladder Cancer knowledge Scale
The intervention is designed to enhance treatment decision making.
Measured: 3 month follow up
Decisional Regret Scale
Bladder Cancer knowledge Scale
The intervention is designed to enhance treatment decision making.
Measured: 6 month follow up
Secondary outcomes (16)
quality of life
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
Measured: Baseline
quality of life
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
Measured: 1 month follow up
quality of life
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
Measured: 3 month follow up
quality of life
FACT-BL, Emotional, physical, function, and social Wellbeing Subscales
Measured: 6 month follow up
post-surgical self-care
FACT-BL Ca additional concern
Measured: Baseline
post-surgical self-care
FACT-BL Ca additional concern
Measured: 1 month follow up
post-surgical self-care
FACT-BL Ca additional concern
Measured: 3 month follow up
post-surgical self-care
FACT-BL Ca additional concern
Measured: 6 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Measured: Baseline
CES-D scale Illness Perception Questionnaire (IPQ)
Measured: 1 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Measured: 3 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Measured: 6 month follow up
Cancer worries scale
Measured: Baseline
Cancer worries scale
Measured: 1 month follow up
Cancer worries scale
Measured: 3 month follow up
Cancer worries scale
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startSep 2013
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nihal E Mohamed, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915121
- Sponsor's protocol ID
- GCO 09-0479
- Status last verified
- Aug 2017
- First submitted
- 30 Jul 2013
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Intervention for Patients With Bladder Cancer 121193-MRSG-11-103-01-CPPB American Cancer Society
- ClinicalTrials.gov ID
- NCT01915121
- Acronym / sponsor ID
- GCO 09-0479
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Intervention, Education, Randomized Controlled Trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Intervention | Active comparator | Behavioral: Education InterventionIn this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. |
| Nutrition Intervention | Placebo comparator | Behavioral: Nutrition InterventionIn this session, participant will be provided with information about nutrition information directly related to bladder cancer recovery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- metastatic disease or cancer recurrence
- presence of other primary cancers
- no access to a telephone
- Phase 2 (randomized-controlled-study)
- treatment decision is made and /beginning/completion of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education Intervention1-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. | Behavioural | Education Intervention |
| Nutrition Intervention1-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. | Behavioural | Nutrition Intervention |
Primary outcome
Decisional Regret Scale
Time frame: Baseline
The intervention is designed to enhance treatment decision making.
Decisional Regret Scale
Time frame: 1 month follow up
The intervention is designed to enhance treatment decision making.
Decisional Regret Scale
Time frame: 3 month follow up
The intervention is designed to enhance treatment decision making.
Decisional Regret Scale
Time frame: 6 month follow up
The intervention is designed to enhance treatment decision making.
Decisional Self-Efficacy Scale
Time frame: Baseline
The intervention is designed to enhance treatment decision making.
Decisional Self-Efficacy Scale
Time frame: 1 month follow up
The intervention is designed to enhance treatment decision making.
Decisional Self-Efficacy Scale
Time frame: 3 month follow up
The intervention is designed to enhance treatment decision making.
Decisional Self-Efficacy Scale
Time frame: 6 month follow up
The intervention is designed to enhance treatment decision making.
Treatment-related Values
Time frame: Baseline
The intervention is designed to enhance treatment decision making.
Treatment-related Values
Time frame: 1 month follow up
The intervention is designed to enhance treatment decision making.
Treatment-related Values
Time frame: 3 month follow up
The intervention is designed to enhance treatment decision making.
Treatment-related Values
Time frame: 6 month follow up
The intervention is designed to enhance treatment decision making.
Decisional Regret Scale
Time frame: Baseline
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
Decisional Regret Scale
Time frame: 1 month follow up
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
Decisional Regret Scale
Time frame: 3 month follow up
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
Decisional Regret Scale
Time frame: 6 month follow up
Bladder Cancer knowledge Scale The intervention is designed to enhance treatment decision making.
16 secondary outcomes
quality of life
Time frame: Baseline
quality of life
Time frame: 1 month follow up
quality of life
Time frame: 3 month follow up
quality of life
Time frame: 6 month follow up
post-surgical self-care
Time frame: Baseline
post-surgical self-care
Time frame: 1 month follow up
post-surgical self-care
Time frame: 3 month follow up
post-surgical self-care
Time frame: 6 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Time frame: Baseline
CES-D scale Illness Perception Questionnaire (IPQ)
Time frame: 1 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Time frame: 3 month follow up
CES-D scale Illness Perception Questionnaire (IPQ)
Time frame: 6 month follow up
Cancer worries scale
Time frame: Baseline
Cancer worries scale
Time frame: 1 month follow up
Cancer worries scale
Time frame: 3 month follow up
Cancer worries scale
Time frame: 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
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Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingObservational study
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Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
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RecruitingPhase 2
A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihal E Mohamed, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Intervention and Nutrition Intervention in people with Bladder Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Regret Scale (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.