ChemotherapyNCT01722123
Effects of Frequent Decision Making Among Patients With Serious Illnesses
A study testing Hypothetical scenarios and related decisions in people with Chemotherapy, run by University of Pennsylvania at 1 site in United States.
Trial summary
Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The result is decision fatigue, in which subsequent decisions are altered toward the status quo. Patients are at risk for decision fatigue yet it has not been studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy
- What is being tested?
- Hypothetical scenarios and related decisions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma
- All participants must be over the age 18
- All participants must be fluent in English
Who cannot join
- Any medical condition known to alter Stroop performance; i.e. significant visual impairment, blind or colorblind, sedating medications during appointment, history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness
- Patients will also be ineligible if they are illiterate
- Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the hypothetical medical scenarios/decisions
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Study of Repeated Decision Making in Patients
Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The result is decision fatigue, in which subsequent decisions are altered toward the status quo. Patients are at risk for decision fatigue yet it has not been studied. The Investigator proposes a randomized study in the outpatient setting in patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on participant self-control and subsequent choices.
Read the detailed description
Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made. This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue. (1) People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo. By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities. Patients and their surrogates often make complex medical decisions for which they may have little experience. Although clearly at high risk, decision fatigue has not been studied this population. To elucidate these questions, we propose a four arm study of patients in a population at high risk for making complex decisions. Participants will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.
- Conditions
- Chemotherapy
- Being tested
- Hypothetical scenarios and related decisions
- Keywords
- Decision fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothetical scenarios and related decisionsOther
Patients are exposed to three hypothetical medical scenarios that require varying levels of decision making. We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
| Study group | Role | What they receive |
|---|---|---|
| DLST Only | No intervention | Patients will complete the Stroop test then answer the hypothetical life sustaining therapy (LST) |
| Contemplate only | Experimental | Patients will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question Receives: Other: Hypothetical scenarios and related decisions |
| Decide with advice | Experimental | Patients will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question. Within this arm, patients will receive two positive recommendations (i.e. to go ahead with the intervention) and two negative recommendations (i.e. to decline the intervention). These positive and negative recommendations will be randomly assigned upon study enrollment. With four hypothetical scenarios, there are six possible options for recommendation variations. Receives: Other: Hypothetical scenarios and related decisions |
| Decide without advice | Experimental | Patients will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question. Receives: Other: Hypothetical scenarios and related decisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop test score
Measurement of score will be done at the conclusion of instrument completion. The Stroop test is a standard measure of self control that requires three tasks. The last task is the most difficult where the participant must suppress the urge to read the word which is the easier task and instead say the color it is printed in. Standard scoring is the number correct in the W trial minus the CW trials. This data will be collected immediately following completion.
Measured: Approximately 15 minutes
Secondary outcomes (1)
Evidence of status quo bias
Evidence of status quo bias as assessed by hypothetical decision to limit life sustaining therapy or to continue treatment. To assess for status quo bias, we will use the following technique: after the initial four hypothetical questions and Stroop testing, participants will be asked a hypothetical question about life sustaining therapy (LST). In the question, continuing life sustaining therapy will be counted as maintaining the status quo. This is based on current norms in American health care where life sustaining therapy is continued until a patient or surrogate specifically request otherwise.
Measured: Approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Halpern, University of Pennsylvania
- Investigators
- Scott D. Halpern, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722123
- Sponsor's protocol ID
- UPenn -816696
- Status last verified
- Aug 2017
- First submitted
- 31 Oct 2012
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vohs KD, Baumeister RF, Schmeichel BJ, Twenge JM, Nelson NM, Tice DM. Making choices impairs subsequent self-control: a limited-resource account of decision making, self-regulation, and active initiative. J Pers Soc Psychol. 2008 May;94(5):883-98. doi: 10.1037/0022-3514.94.5.883.
PubMed 18444745
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Repeated Decision Making in Patients
- ClinicalTrials.gov ID
- NCT01722123
- Acronym / sponsor ID
- UPenn -816696
- Conditions
- Chemotherapy
- Keywords
- Decision fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 6 Nov 2012 (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.
Decision making capacity fatigues after repeated decisions similar to skeletal muscle. The result is decision fatigue, in which subsequent decisions are altered toward the status quo. Patients are at risk for decision fatigue yet it has not been studied. The Investigator proposes a randomized study in the outpatient setting in patients at high risk for needing to make complex decisions, in an effort to determine the impact of decision fatigue on participant self-control and subsequent choices.
Detailed description
Just as skeletal muscle fatigues after repeated use, decision-making capacity fatigues when repeated choices are made. This phenomenon, in which people experience diminished concentration and willpower after repeated decision-making, is termed decision fatigue. (1) People experiencing decision fatigue are more likely to bias subsequent choices toward the status quo. By choosing the status quo, the decision-maker reserves the option to make an alternate choice at a later time, thereby preserving possibilities. Patients and their surrogates often make complex medical decisions for which they may have little experience. Although clearly at high risk, decision fatigue has not been studied this population. To elucidate these questions, we propose a four arm study of patients in a population at high risk for making complex decisions. Participants will be randomly assigned to varied levels of decision making effort to assess for the development of resultant decision fatigue and whether it alters subsequent decisions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DLST Only | No intervention | –Patients will complete the Stroop test then answer the hypothetical life sustaining therapy (LST) |
| Contemplate only | Experimental | Other: Hypothetical scenarios and related decisionsPatients will contemplate each of the 3 scenarios but not make any decisions, then complete the Stroop test and answer the hypothetical LST question |
| Decide with advice | Experimental | Other: Hypothetical scenarios and related decisionsPatients will make decisions on 4 scenarios with physician advice, then complete the Stroop test and answer the hypothetical LST question. Within this arm, patients will receive two positive recommendations (i.e. to go ahead with the intervention) and two negative recommendations (i.e. to decline the intervention). These positive and negative recommendations will be randomly assigned upon study enrollment. With four hypothetical scenarios, there are six possible options for recommendation variations. |
| Decide without advice | Experimental | Other: Hypothetical scenarios and related decisionsPatients will make decisions on 4 scenarios without physician advice, then complete the Stroop test and the hypothetical LST question. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aplastic anemia, multiple myeloma, myelodysplastic syndrome, acute myeloid leukemia, stage IIIB or IV lung cancer, mesothelioma and/or stage IIIB or IV gastrointestinal cancer (pancreatic, biliary, esophageal, gastric, hepatocellular, colon), stage IV melanoma
- All participants must be over the age 18
- All participants must be fluent in English
Key exclusion criteria (3 listed)
- Any medical condition known to alter Stroop performance; i.e. significant visual impairment, blind or colorblind, sedating medications during appointment, history of cerebrovascular accident, transient ischemic attack (TIA), seizure disorder, dementia or traumatic head injury with loss of consciousness
- Patients will also be ineligible if they are illiterate
- Patients will be ineligible if they have either tracheostomy or are currently on hemodialysis as these would significantly alter responses to the hypothetical medical scenarios/decisions
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 |
|---|---|---|
| Hypothetical scenarios and related decisionsPatients are exposed to three hypothetical medical scenarios that require varying levels of decision making. We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy. | Other | Contemplate only, Decide with advice, Decide without advice |
Primary outcome
Stroop test score
Time frame: Approximately 15 minutes
Measurement of score will be done at the conclusion of instrument completion. The Stroop test is a standard measure of self control that requires three tasks. The last task is the most difficult where the participant must suppress the urge to read the word which is the easier task and instead say the color it is printed in. Standard scoring is the number correct in the W trial minus the CW trials. This data will be collected immediately following completion.
1 secondary outcome
Evidence of status quo bias
Time frame: Approximately 10 minutes
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 15 Aug 2017.
- Background: PubMed 18444745Vohs KD, Baumeister RF, Schmeichel BJ, Twenge JM, Nelson NM, Tice DM. Making choices impairs subsequent self-control: a limited-resource account of decision making, self-regulation, and active initiative. J Pers Soc Psychol. 2008 May;94(5):883-98. doi: 10.1037/0022-3514.94.5.883.
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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.
Scott D. Halpern, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothetical scenarios and related decisions in people with Chemotherapy, run by University of Pennsylvania at 1 site 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 3 inclusion and 3 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 15 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 1 site 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. 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?
Stroop test score (time frame: Approximately 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722123, which also lists 1 linked publication.
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 15 Aug 2017.