Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer, Unresectable Pancreatic Cancer
Conditions
Keywords
cancer, palliative, chemotherapy, metastatic, colorectal, communication, informed consent, video, education, oncology, patient-centered, outcomes research
Brief summary
Patients are routinely asked to sign an informed consent document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic moment to equip patients with information they need to make truly informed medical decisions, many patients and caregivers note that these conversations are less useful than they could be. The informed consent process and its associated documents suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials focus on individual drugs instead of regimens; 3) information is presented in written instead of alternative written/audiovisual format; and 4) the patient perspective is lacking. The overarching objective of this project is to develop a library of communication tools for the most common chemotherapy regimens used to treat advanced gastrointestinal cancers. Tools will include video clips and written documents that can be readily distributed, modified, and customized. This toolkit will be crafted in collaboration with oncologists and patients living with gastrointestinal cancer and improves upon existing resources in several ways: 1) balanced discussion of benefits as well as risks, 2) focus on regimens rather than drugs, 3) use of both written and video format, and 4) inclusion of the patient perspective (e.g. video clips of patients describing their experience). A panel of oncologist and patient stakeholders will evaluate the acceptability of the tools. The investigators will then conduct a randomized clinical trial to demonstrate if the informed consent toolkit improves the quality of informed consent for palliative chemotherapy. If effective, the tools will be amenable to broad dissemination via patient accessible cancer education websites and oncology clinics.
Detailed description
Research indicates that many patients with advanced cancer receive palliative chemotherapy without sufficient understanding of its likely risks and benefits. In surveys, many patients receive palliative chemotherapy without expressing an understanding that cure is unlikely. The root of this problem is undoubtedly complex, but may relate to gaps in communication and patient education about the risks and benefits of treatment. Patients are routinely asked to sign an informed consent document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic moment to equip patients with information they need to make truly informed medical decisions, many patients and caregivers note that these conversations are less useful than they could be. The informed consent process and its associated documents suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials focus on individual drugs instead of regimens; 3) information is presented in written instead of alternative written/audiovisual format; and 4) the patient perspective is lacking. The overarching objective of this trial is to test a suite of patient-centered videos and booklets to support informed consent for common chemotherapy regimens used to treat advanced gastrointestinal cancers. In this study, patients with metastatic colorectal cancer, locally advanced and metastatic pancreatic cancer considering treatment with first or second-line palliative chemotherapy were randomized to the usual process of chemotherapy informed consent, or usual care supplemented by access to the appropriate investigational chemotherapy informed consent video and booklet. Patients were surveyed at baseline, 2-weeks post-treatment initiation, and 3 months regarding their understanding of chemotherapy risks and benefits, decisional conflict, and other metrics of informed decision-making.
Interventions
OTHERInvestigational informed consent for chemotherapy
Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.
OTHERUsual, standard-of-care informed consent for chemotherapy
The enrolling site's institutional standard-of-care informed consent materials.
Sponsors
Patient-Centered Outcomes Research Institute
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of advanced colorectal cancer with metastasis, locally advanced pancreatic cancer, or metastatic pancreatic cancer. * Is considering treatment with 1st line or 2nd line chemotherapy * Treating oncologist has recommended consideration of one or more of the regimens for which we have developed informed consent materials * Age ≥ 21 * English proficiency (reading and speaking)
Exclusion criteria
* Significant delirium/dementia as judged by the treating physician * Isolated liver metastases being evaluated for curative resection In addition, caregivers of eligible patients will also be eligible to participate in the caregivers assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Accurate Understanding of Chemotherapy Benefits | 3 months | Patients were asked How likely do you think that chemotherapy is to cure your cancer? with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of not at all likely was considered accurate. All other responses, including don't know, were considered inaccurate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy | 2 weeks | Patients were asked according to your doctor, what is the goal of the chemotherapy? with the ability to choose any/all of the following response options: cure, control cancer growth, alleviate symptoms, prolong life, or other. Selecting either control cancer growth, and/or alleviate symptoms, and/or prolong life were defined as accurate understanding; to cure was considered inaccurate. |
| Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores | 2 weeks | Decisional Conflict was assessed by a modified version of the 4 item SURE instrument of Legare at al which assesses whether patients 1) are sure of the best treatment option, 2) know the risks and benefits of their treatment options, 3) are clear about which risks and benefits matter to them, and 4) whether they have sufficient support to make their treatment decision. We expanded items 2 and 3 into four separate items assessing risks and benefits individually. Responses were summed, resulting in a scale of 0-6, where 0 indicates maximum conflict and 6 indicates no conflict |
| Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process | 2 weeks | Achievement of preferred role in decision-making was assessed by the Control Preferences Scale; patients indicate the role they played in their treatment decision which is compared to their preferred role (assessed at baseline). |
| Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores | 2 weeks | Satisfaction with communication during treatment decision-making process was assessed via 5 items from the Patient Assessment of Cancer Communication Experiences (PACE). Scores were averaged (does not apply excluded), creating a score of 1 to 4, with 4 being the most satisfied. |
| Number of Patients With Accurate Understanding of Chemotherapy Risks | 2 weeks | Patients were asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration, with separate items for nausea/vomiting, diarrhea, neuropathy, and hair loss. Patients' responses were correlated to the known side effect profile of their chemotherapy regimen and coded as accurate or inaccurate. |
| Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale | 3 months | Decisional Regret was assessed at the 3-month survey using Brehaut's 5-item decisional regret scale, with scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret. |
| Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment | 3 months | Emotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable. |
| Patient-Reported Prognostic Understanding in Median Years | 3 months | Prognostic understanding was assessed by asking patients about their understanding of the prognosis of the typical patient with their condition (\<1 year, 1-2 years, 2- 3 years, 3-5 years, 5-10 years, \>10 years). This measure was adapted from the CANCORS trial. |
| Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | 3 months | — |
Countries
United States
Participant flow
Pre-assignment details
216 participants were consented to this study. Of these, 16 were were not eligible to be randomized and 14 did not complete a baseline assessment. After consultations with the study statistician, these participants were intentionally excluded from our analytic cohort. Therefore, 186 participants are included in the participant flow module.
Participants by arm
| Arm | Count |
|---|---|
| Usual Informed Consent Study participant will receive usual, standard-of-care informed consent for chemotherapy materials.
Usual, standard-of-care informed consent for chemotherapy: The enrolling site's institutional standard-of-care informed consent materials. | 94 |
| Investigational Informed Consent Study participant will receive investigational informed consent for chemotherapy materials that were developed by the study team.
Investigational informed consent for chemotherapy: Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet. | 92 |
| Total | 186 |
Baseline characteristics
| Characteristic | Usual Informed Consent | Investigational Informed Consent | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 36 Participants | 73 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 56 Participants | 113 Participants |
| Age, Continuous | 59.2 Years | 59.4 Years | 59.3 Years |
| Diagnosis Advanced pancreatic cancer | 35 Participants | 33 Participants | 68 Participants |
| Diagnosis Metastatic colorectal cancer | 59 Participants | 59 Participants | 118 Participants |
| ECOG Performance Status 0 - Fully Active | 31 Participants | 44 Participants | 75 Participants |
| ECOG Performance Status 1 - Restricted in physically strenuous activity | 42 Participants | 26 Participants | 68 Participants |
| ECOG Performance Status 2 - Ambulatory but unable to work | 5 Participants | 6 Participants | 11 Participants |
| ECOG Performance Status 3 - Capable of limited self-care | 0 Participants | 0 Participants | 0 Participants |
| ECOG Performance Status 4 - Completely disabled | 0 Participants | 0 Participants | 0 Participants |
| ECOG Performance Status Unknown/Missing | 16 Participants | 16 Participants | 32 Participants |
| Education College degree or higher | 49 Participants | 57 Participants | 106 Participants |
| Education Grade school or less | 8 Participants | 5 Participants | 13 Participants |
| Education High school graduate, or some college | 36 Participants | 29 Participants | 65 Participants |
| Education Unknown/missing | 1 Participants | 1 Participants | 2 Participants |
| Live alone No | 76 Participants | 79 Participants | 155 Participants |
| Live alone Unknown | 2 Participants | 1 Participants | 3 Participants |
| Live alone Yes | 16 Participants | 12 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 6 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 76 Participants | 84 Participants | 160 Participants |
| Sex: Female, Male Female | 40 Participants | 39 Participants | 79 Participants |
| Sex: Female, Male Male | 54 Participants | 53 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 92 |
| other Total, other adverse events | 0 / 94 | 0 / 92 |
| serious Total, serious adverse events | 0 / 94 | 0 / 92 |
Outcome results
Primary
Number of Patients With Accurate Understanding of Chemotherapy Benefits
Patients were asked How likely do you think that chemotherapy is to cure your cancer? with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of not at all likely was considered accurate. All other responses, including don't know, were considered inaccurate.
Time frame: 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Usual Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Benefits | Accurate | 39 Participants |
| Patient Usual Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Benefits | Inaccurate | 30 Participants |
| Patient Usual Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Benefits | Did not answer | 2 Participants |
| Patient Investigational Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Benefits | Accurate | 39 Participants |
| Patient Investigational Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Benefits | Inaccurate | 31 Participants |
| Patient Investigational Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Benefits | Did not answer | 3 Participants |
Secondary
Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores
Decisional Conflict was assessed by a modified version of the 4 item SURE instrument of Legare at al which assesses whether patients 1) are sure of the best treatment option, 2) know the risks and benefits of their treatment options, 3) are clear about which risks and benefits matter to them, and 4) whether they have sufficient support to make their treatment decision. We expanded items 2 and 3 into four separate items assessing risks and benefits individually. Responses were summed, resulting in a scale of 0-6, where 0 indicates maximum conflict and 6 indicates no conflict
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Usual Care Arm | Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores | 5.2 units on a scale | Standard Deviation 1.7 |
| Patient Investigational Care Arm | Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores | 5.5 units on a scale | Standard Deviation 1.2 |
Secondary
Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale
Decisional Regret was assessed at the 3-month survey using Brehaut's 5-item decisional regret scale, with scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Usual Care Arm | Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale | 79.6 units on a scale | Standard Deviation 19.3 |
| Patient Investigational Care Arm | Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale | 84.7 units on a scale | Standard Deviation 14.4 |
Secondary
Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment
Emotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Usual Care Arm | Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment | 16.5 units on a scale | Standard Deviation 4.6 |
| Patient Investigational Care Arm | Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment | 17.3 units on a scale | Standard Deviation 4.5 |
Secondary
Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process
Achievement of preferred role in decision-making was assessed by the Control Preferences Scale; patients indicate the role they played in their treatment decision which is compared to their preferred role (assessed at baseline).
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Usual Care Arm | Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process | No | 48 Participants |
| Patient Usual Care Arm | Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process | Yes | 30 Participants |
| Patient Usual Care Arm | Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process | Unknown/missing | 1 Participants |
| Patient Investigational Care Arm | Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process | No | 39 Participants |
| Patient Investigational Care Arm | Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process | Yes | 35 Participants |
| Patient Investigational Care Arm | Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process | Unknown/missing | 1 Participants |
Secondary
Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team
Time frame: 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Usual Care Arm | Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | No | 60 Participants |
| Patient Usual Care Arm | Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | Yes | 10 Participants |
| Patient Usual Care Arm | Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | Unknown/missing | 1 Participants |
| Patient Investigational Care Arm | Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | No | 55 Participants |
| Patient Investigational Care Arm | Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | Yes | 16 Participants |
| Patient Investigational Care Arm | Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team | Unknown/missing | 2 Participants |
Secondary
Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy
Patients were asked according to your doctor, what is the goal of the chemotherapy? with the ability to choose any/all of the following response options: cure, control cancer growth, alleviate symptoms, prolong life, or other. Selecting either control cancer growth, and/or alleviate symptoms, and/or prolong life were defined as accurate understanding; to cure was considered inaccurate.
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Usual Care Arm | Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy | Inaccurate | 10 Participants |
| Patient Usual Care Arm | Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy | Accurate | 68 Participants |
| Patient Usual Care Arm | Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy | Unknown/missing | 1 Participants |
| Patient Investigational Care Arm | Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy | Inaccurate | 9 Participants |
| Patient Investigational Care Arm | Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy | Accurate | 65 Participants |
| Patient Investigational Care Arm | Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy | Unknown/missing | 1 Participants |
Secondary
Number of Patients With Accurate Understanding of Chemotherapy Risks
Patients were asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration, with separate items for nausea/vomiting, diarrhea, neuropathy, and hair loss. Patients' responses were correlated to the known side effect profile of their chemotherapy regimen and coded as accurate or inaccurate.
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Usual Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Risks | Inaccurate | 47 Participants |
| Patient Usual Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Risks | Accurate | 31 Participants |
| Patient Usual Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Risks | Unknown/missing | 1 Participants |
| Patient Investigational Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Risks | Inaccurate | 33 Participants |
| Patient Investigational Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Risks | Accurate | 41 Participants |
| Patient Investigational Care Arm | Number of Patients With Accurate Understanding of Chemotherapy Risks | Unknown/missing | 1 Participants |
Secondary
Patient-Reported Prognostic Understanding in Median Years
Prognostic understanding was assessed by asking patients about their understanding of the prognosis of the typical patient with their condition (\<1 year, 1-2 years, 2- 3 years, 3-5 years, 5-10 years, \>10 years). This measure was adapted from the CANCORS trial.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient Usual Care Arm | Patient-Reported Prognostic Understanding in Median Years | 2.5 years |
| Patient Investigational Care Arm | Patient-Reported Prognostic Understanding in Median Years | 2.5 years |
Secondary
Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores
Satisfaction with communication during treatment decision-making process was assessed via 5 items from the Patient Assessment of Cancer Communication Experiences (PACE). Scores were averaged (does not apply excluded), creating a score of 1 to 4, with 4 being the most satisfied.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Usual Care Arm | Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores | 3.6 units on a scale | Standard Deviation 0.5 |
| Patient Investigational Care Arm | Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores | 3.7 units on a scale | Standard Deviation 0.4 |