Advanced Malignant NeoplasmNCT03287492
RCT of QPS vs General Information Sheet
A study testing Informational Intervention and Questionnaire Administration in people with Advanced Malignant Neoplasm and Caregiver, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Neoplasm, Caregiver, Physician
- What is being tested?
- Informational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (Patient participation) First outpatient consultation visit with a palliative care specialist
- (Patient participation) Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits, as determined by the patient's physician
- (Patient participation) Ability to read and communicate in English
- (Patient participation) Diagnosis of advanced cancer
- (Patient participation) Signed written informed consent form
- (Caregiver participation) accompanied the patient to the clinic visit
Show all 12Show fewer
- (Caregiver participation) is identified by the patient as someone who is actively involved in their overall care
- (Caregiver participation) is able to read and communicate in English
- (Caregiver participation) is willing to participate in the study and able to complete the questionnaires
- (Physician participation) a palliative medicine specialist
- (Physician participation) seeing the patient in consultation on the day of the study
- (Physician participation) willing to participate in the study
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer
This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Approaches that encourage participants to actively participate and ask appropriate questions during their visit may be important to enhance their understanding of their illness and empower them to make important decisions regarding their medical care.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare patients' perception of helpfulness in communicating with their physicians between a question prompt sheet (QPS) and a general information sheet (GIS).
SECONDARY OBJECTIVES:
- To compare caregivers' perception of helpfulness in communicating with their physicians between the QPS and the GIS.
II. To examine the level of patients' and caregivers' overall satisfaction with the consultation with the use of the QPS versus the GIS.
III. To examine physicians' views about the information material and overall satisfaction with the use of the QPS versus the GIS.
IV. To explore how the use of QPS affects the average speaking time of patient or physician during the consultation visit.
- To establish demographic and clinical predictors of patients' perception of helpfulness of a QPS.
VI. To examine the overall patients' preference between the QPS and GIS in an open label phase.
VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.
VIII. To explore the factors underlying patients' preferences for the QPS or GIS.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
GROUP II: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
- Conditions
- Advanced Malignant Neoplasm, Caregiver, Physician
- Being tested
- Informational Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive QPS
Informational InterventionOther
Receive GIS
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (QPS) | Experimental | Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| Group II (GIS) | Active comparator | Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit
Standard statistics including mean, standard deviation, median, range, frequency and percentage will be summarized for variables of interest, such as patients' demographics, clinical characteristics, anxiety state, patients'/caregivers' views about the information material, patients' satisfaction, physicians' views about the information material and consultation, patients' preferences for information, patient preferences for level of involvement in decision-making and patients' overall preference between the question prompt sheet (QPS) and the general information sheet (GIS) at the follow-up visit. Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare continuous variables of interest between the QPS and the GIS. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between categorical variables and helpfulness of information material.
Measured: Up to 3 years
Secondary outcomes (7)
Caregivers' perception of helpfulness in communicating with their physicians
Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
Measured: Up to 3 years
Patients'/caregivers' overall satisfaction with the consultation
Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
Measured: Up to 3 years
Physician's view/overall satisfaction about the information material
Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
Measured: Up to 3 years
Average speaking time of patient or physician during the consultation visit affected by QPS
Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare the average speaking time of patient or physician during the consultation visit. Also, general linear model will be applied to assess the effect of QPS on the average speaking time adjusting for clinically and/or statistically important factors.
Measured: Up to 3 years
Overall patients' preference between the QPS and GIS in an open label phase
Will estimate the preference of information material with 95% confidence intervals. Also, univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on overall patients' preference between QPS and GIS.
Measured: Up to 3 years
Change in patient anxiety state scores before and after consultation between the QPS and the GIS
Sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used.
Measured: Baseline up to 6 weeks
Demographic and clinical predictors of patients' perception of helpfulness of a QPS
Univariate/multicovariate logistic regression will be used to evaluate patients' demographic and clinical factors on patients' perception of helpfulness of QPS when dichotomizing the answer to the question 3 in the Patient/Caregiver Assessment Questionnaire ("Agree/Strongly Agree"=Helpful versus the rest).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start25 Sep 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph A Arthur, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287492
- Sponsor's protocol ID
- 2017-0028
- Other IDs
- NCI-2018-01052, 2017-0028
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2017
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arthur J, Pawate V, Lu Z, Yennurajalingam S, Azhar A, Reddy A, Epner D, Hui D, Tanco K, Delgado Guay MO, Vidal M, Chen M, Bruera E. Helpfulness of Question Prompt Sheet for Patient-Physician Communication Among Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2311189. doi: 10.1001/jamanetworkopen.2023.11189.
PubMed 37129892
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03287492
- Acronym / sponsor ID
- 2017-0028
- Conditions
- Advanced Malignant Neoplasm, Caregiver, Physician
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 207 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2017 (actual)
- 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.
This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Approaches that encourage participants to actively participate and ask appropriate questions during their visit may be important to enhance their understanding of their illness and empower them to make important decisions regarding their medical care.
Detailed description
PRIMARY OBJECTIVES:
- To compare patients' perception of helpfulness in communicating with their physicians between a question prompt sheet (QPS) and a general information sheet (GIS).
SECONDARY OBJECTIVES:
- To compare caregivers' perception of helpfulness in communicating with their physicians between the QPS and the GIS.
II. To examine the level of patients' and caregivers' overall satisfaction with the consultation with the use of the QPS versus the GIS.
III. To examine physicians' views about the information material and overall satisfaction with the use of the QPS versus the GIS.
IV. To explore how the use of QPS affects the average speaking time of patient or physician during the consultation visit.
- To establish demographic and clinical predictors of patients' perception of helpfulness of a QPS.
VI. To examine the overall patients' preference between the QPS and GIS in an open label phase.
VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.
VIII. To explore the factors underlying patients' preferences for the QPS or GIS.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
GROUP II: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (QPS) | Experimental | Other: Informational Intervention, Other: Questionnaire AdministrationParticipants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS. |
| Group II (GIS) | Active comparator | Other: Informational Intervention, Other: Questionnaire AdministrationParticipants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- (Patient participation) First outpatient consultation visit with a palliative care specialist
- (Patient participation) Normal cognitive status, defined as a normal state of arousal and an absence of obvious clinical findings of confusion, memory deficits or concentration deficits, as determined by the patient's physician
- (Patient participation) Ability to read and communicate in English
- (Patient participation) Diagnosis of advanced cancer
- (Patient participation) Signed written informed consent form
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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 |
|---|---|---|
| Informational InterventionReceive QPS | Other | Group I (QPS) |
| Informational InterventionReceive GIS | Other | Group II (GIS) |
| Questionnaire AdministrationAncillary studies | Other | Group I (QPS), Group II (GIS) |
Primary outcome
Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit
Time frame: Up to 3 years
Standard statistics including mean, standard deviation, median, range, frequency and percentage will be summarized for variables of interest, such as patients' demographics, clinical characteristics, anxiety state, patients'/caregivers' views about the information material, patients' satisfaction, physicians' views about the information material and consultation, patients' preferences for information, patient preferences for level of involvement in decision-making and patients' overall preference between the question prompt sheet (QPS) and the general information sheet (GIS) at the follow-up visit. Two sample t-test or Wilcoxon rank sum test, whichever appropriate, will be used to compare continuous variables of interest between the QPS and the GIS. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between categorical variables and helpfulness of information material.
7 secondary outcomes
Caregivers' perception of helpfulness in communicating with their physicians
Time frame: Up to 3 years
Patients'/caregivers' overall satisfaction with the consultation
Time frame: Up to 3 years
Physician's view/overall satisfaction about the information material
Time frame: Up to 3 years
Average speaking time of patient or physician during the consultation visit affected by QPS
Time frame: Up to 3 years
Overall patients' preference between the QPS and GIS in an open label phase
Time frame: Up to 3 years
Change in patient anxiety state scores before and after consultation between the QPS and the GIS
Time frame: Baseline up to 6 weeks
Demographic and clinical predictors of patients' perception of helpfulness of a QPS
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 37129892Arthur J, Pawate V, Lu Z, Yennurajalingam S, Azhar A, Reddy A, Epner D, Hui D, Tanco K, Delgado Guay MO, Vidal M, Chen M, Bruera E. Helpfulness of Question Prompt Sheet for Patient-Physician Communication Among Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2311189. doi: 10.1001/jamanetworkopen.2023.11189.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Joseph A Arthur principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention and Questionnaire Administration in people with Advanced Malignant Neoplasm and Caregiver, run by M.D. Anderson Cancer Center 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 12 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patients' perception of helpfulness (0-10 scale) in communicating with their physicians after the first consultation visit (time frame: Up to 3 years). 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 NCT03287492, 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 16 Jul 2026.