Breast CancerNCT02871115
Pilot Study of a Pharmacy Intervention for Older Adults With Cancer
A study testing Pharmacy Intervention in people with Breast Cancer and Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. The sponsor of this protocol is the Massachusetts General Hospital Cancer Center who is providing funding for this research study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, GI Cancer
- What is being tested?
- Pharmacy Intervention
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 14 Apr 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 or older
- Diagnosed with any stage breast, GI or lung cancer
- Panning to receive first-line chemotherapy at MGH
- Verbal fluency in English
Who cannot join
- Unwilling or unable to participate in the study
- Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts general Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. The sponsor of this protocol is the Massachusetts General Hospital Cancer Center who is providing funding for this research study.
Read the detailed description
The goals of the proposed study are: (1) to demonstrate the feasibility and acceptability of delivering PRIME (Pharmacist Reconciliation to Improve Medication Management in the Elderly) to older patients with breast, gastrointestinal, and lung cancers; and (2) to estimate the effect size (i.e. the magnitude of the difference between groups) of PRIME for improving medication management (e.g. accurate medication list, less polypharmacy, fewer potentially inappropriate medications) and achieving up-to-date vaccinations.
- Conditions
- Breast Cancer, Lung Cancer, GI Cancer
- Being tested
- Pharmacy Intervention, Usual Care
- Keywords
- Cancer Care
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacy InterventionOther
Patients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will: (1) perform detailed medication reconciliation and obtain allergy and vaccination history; (2) evaluate and document polypharmacy, potentially inappropriate medications, lack of appropriate medications; and (3) document their findings in the medical record and discuss their recommendations the oncology team.
Usual CareOther
Participants receiving usual oncology care will not meet with the pharmacist unless indicated as part of their routine clinical care. Study staff will obtain all patient-reported measures from the patient.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacy Intervention | Experimental | Patients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will
* Perform detailed medication reconciliation
* Obtain allergy and vaccination history
* Evaluate and document polypharmacy (number of medications)
* Document their findings in the medical record and discuss their recommendations (in-person, phone call, email) with each patient's oncology team Receives: Other: Pharmacy Intervention |
| Usual Care | Active comparator | Participants receiving Usual Oncology Care will not meet with the pharmacist unless indicated as part of their routine clinical care
* Study staff will obtain all patient-reported measures from the patient.
* Remind participant to complete self-report measures Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of study enrollment
To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study.
Measured: 2 years
Secondary outcomes (12)
Rates of Study Completion
To determine study completion rates, we will evaluate the proportion of patients enrolled who complete the study.
Measured: 2 years
Rates of study satisfaction
To determine rates of study satisfaction, we will examine the proportion of participants who report satisfaction with the structure, timing and content of the study, using Likert-type scale responses.
Measured: 2 years
Rates of Medication List Accuracy
Compare rates of medication list accuracy (defined as concordance between the medical record and the medication list the patient reports taking) between study arms at 4 weeks following enrollment.
Measured: Baseline to 4 weeks
Change In The Number Of Medications
Compare change in the number of medications (defined as the number of medications a patient is prescribed) between study arms from baseline to 4 weeks following enrollment.
Measured: Baseline to 4 weeks
Number Of Medications
Compare the number of medications (defined as the number of medications a patient is prescribed) between study arms at 4 weeks following enrollment.
Measured: Baseline to 4 weeks
Rates of Polypharmacy
Compare rates of polypharmacy (defined as five or more medications) 4 weeks following enrollment between study arms.
Measured: Baseline to 4 weeks
Change In The Number Of Potentially Inappropriate Medications
Compare change in the number of potentially inappropriate medications between study arms from baseline to 4 weeks following enrollment.
Measured: Baseline to 4 weeks
Number Of Potentially Inappropriate Medications
Compare the number of potentially inappropriate medications between study arms at 4 weeks following enrollment.
Measured: Baseline to 4 weeks
Rates Of Appropriate Pneumococcal Vaccinations
Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 4 weeks.
Measured: Baseline to 4 weeks
Rates Of Appropriate Pneumococcal Vaccinations
Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 8 weeks.
Measured: Baseline to 8 weeks
Rates Of Appropriate Influenza Vaccinations
Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 4 weeks.
Measured: Baseline to 4 weeks
Rates Of Appropriate Influenza Vaccinations
Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 8 weeks.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJan 2017
- Primary completion2 Jan 2018
- Study completion14 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Nipp, Massachusetts General Hospital
- Investigators
- Ryan Nipp, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871115
- Sponsor's protocol ID
- 16-230
- Status last verified
- Nov 2021
- First submitted
- 13 Aug 2016
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Pharmacy Intervention for Older Adults With Cancer
- ClinicalTrials.gov ID
- NCT02871115
- Acronym / sponsor ID
- 16-230
- Conditions
- Breast Cancer, Lung Cancer, GI Cancer
- Keywords
- Cancer Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 14 Apr 2018 (actual)
- First posted
- 18 Aug 2016 (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 purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. The sponsor of this protocol is the Massachusetts General Hospital Cancer Center who is providing funding for this research study.
Detailed description
The goals of the proposed study are: (1) to demonstrate the feasibility and acceptability of delivering PRIME (Pharmacist Reconciliation to Improve Medication Management in the Elderly) to older patients with breast, gastrointestinal, and lung cancers; and (2) to estimate the effect size (i.e. the magnitude of the difference between groups) of PRIME for improving medication management (e.g. accurate medication list, less polypharmacy, fewer potentially inappropriate medications) and achieving up-to-date vaccinations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacy Intervention | Experimental | Other: Pharmacy InterventionPatients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will * Perform detailed medication reconciliation * Obtain allergy and vaccination history * Evaluate and document polypharmacy (number of medications) * Document their findings in the medical record and discuss their recommendations (in-person, phone call, email) with each patient's oncology team |
| Usual Care | Active comparator | Other: Usual CareParticipants receiving Usual Oncology Care will not meet with the pharmacist unless indicated as part of their routine clinical care * Study staff will obtain all patient-reported measures from the patient. * Remind participant to complete self-report measures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 or older
- Diagnosed with any stage breast, GI or lung cancer
- Panning to receive first-line chemotherapy at MGH
- Verbal fluency in English
Key exclusion criteria (2 listed)
- Unwilling or unable to participate in the study
- Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation 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 |
|---|---|---|
| Pharmacy InterventionPatients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will: (1) perform detailed medication reconciliation and obtain allergy and vaccination history; (2) evaluate and document polypharmacy, potentially inappropriate medications, lack of appropriate medications; and (3) document their findings in the medical record and discuss their recommendations the oncology team. | Other | Pharmacy Intervention |
| Usual CareParticipants receiving usual oncology care will not meet with the pharmacist unless indicated as part of their routine clinical care. Study staff will obtain all patient-reported measures from the patient. | Other | Usual Care |
Primary outcome
Rates of study enrollment
Time frame: 2 years
To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study.
12 secondary outcomes
Rates of Study Completion
Time frame: 2 years
Rates of study satisfaction
Time frame: 2 years
Rates of Medication List Accuracy
Time frame: Baseline to 4 weeks
Change In The Number Of Medications
Time frame: Baseline to 4 weeks
Number Of Medications
Time frame: Baseline to 4 weeks
Rates of Polypharmacy
Time frame: Baseline to 4 weeks
Change In The Number Of Potentially Inappropriate Medications
Time frame: Baseline to 4 weeks
Number Of Potentially Inappropriate Medications
Time frame: Baseline to 4 weeks
Rates Of Appropriate Pneumococcal Vaccinations
Time frame: Baseline to 4 weeks
Rates Of Appropriate Pneumococcal Vaccinations
Time frame: Baseline to 8 weeks
Rates Of Appropriate Influenza Vaccinations
Time frame: Baseline to 4 weeks
Rates Of Appropriate Influenza Vaccinations
Time frame: Baseline to 8 weeks
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 12 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Ryan Nipp, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacy Intervention in people with Breast Cancer and Lung Cancer, run by Massachusetts General Hospital 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 4 inclusion and 2 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 12 Nov 2021. 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?
Rates of study enrollment (time frame: 2 years). 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 12 Nov 2021.