Other CancerNCT03721926
A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer
A study testing Geriatric Oncology Collaborative Care in people with Other Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Other Cancer
- What is being tested?
- Geriatric Oncology Collaborative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 31 Mar 2022
- 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 advanced (defined as metastatic or receiving therapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, renal, bladder, or prostate cancer within the past 8 weeks (includes patients with a new diagnosis, progression or recurrence).
- ECOG performance status of 0-2
- Ability to read and respond to questions in English
- Planning to receive care at MGH
Who cannot join
- Uncontrolled psychiatric illness or impaired cognition
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02214
About this study
The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers.
Read the detailed description
Cancer disproportionately affects older adults, and the number of older adults with cancer is expected to grow as the population ages. Older adults with advanced cancer often possess a distinct set of medical and psycho-social issues that makes caring for the geriatric oncology population challenging for oncologists. Currently, a critical knowledge gap exists regarding how best to deliver comprehensive cancer care targeting the unique geriatric and palliative care needs of these individuals. The investigators propose to develop a geriatric oncology collaborative care intervention to improve supportive care outcomes for older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancer. GI and GU cancers are among the leading causes of cancer death in the geriatric cancer population, and patients with advanced GI and GU cancers experience a high symptom burden. The intervention will entail visits with an oncology advanced practice nurse trained to address patients' unique needs, who will meet regularly with a supervising team of geriatric, palliative care, social work, and pharmacy clinicians for feedback and iterative reevaluation of the care plan. Using nurses who are already integrated into the oncology setting represents a scalable model that addresses the workforce shortage of geriatric and palliative care clinicians. The investigators used conceptual models for collaborative care and geriatric interventions to develop an initial intervention framework, and prior research to develop a preliminary intervention manual. In Aim 1, the investigators will refine and finalize both the intervention and the intervention manual based on qualitative data from patients, caregivers, and clinicians to ensure the intervention targets the unique needs of older adults with advanced cancer. In Aim 2, the investigators will modify the intervention and study methods with an open pilot study (n=10). In Aim 3, the investigators will conduct a pilot randomized trial (n=75) to assess the feasibility and preliminary efficacy of the geriatric oncology collaborative care intervention for improving patients' QOL, symptom burden, and functional outcomes.
- Conditions
- Other Cancer
- Being tested
- Usual Care, Geriatric Oncology Collaborative Care
- Keywords
- Other Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Participants assigned to receive usual oncology care will not meet with the study nurses, though they may receive geriatric or palliative care consults at their request or at the discretion of their treating oncologist.
Geriatric Oncology Collaborative CareOther
Patients receive three visits with a trained study nurse. At each visit, the study nurse will assess the patient's symptom burden, functional status, comorbid conditions, psychosocial issues, and medication use. The nurses can refer patients to specialists as needed. The study nurses will meet with a supervising support team, consisting of clinicians from geriatrics, palliative care, social work, and pharmacy to discuss each patient and review documentation. Following the team meetings, the nurses will document recommendations in the medical record and communicate with the primary oncology team, either in person or via phone, as appropriate. The study nurses will contact the supervising team in between meetings for any urgent issues or questions that arise.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Oncology Collaborative Care | Experimental | Patients receive three visits with a trained study nurse. At each visit, the study nurse will assess the patient's symptom burden, functional status, comorbid conditions, psychosocial issues, and medication use. The nurses can refer patients to specialists as needed. The study nurses will meet with a supervising support team, consisting of clinicians from geriatrics, palliative care, social work, and pharmacy to discuss each patient and review documentation. Following the team meetings, the nurses will document recommendations in the medical record and communicate with the primary oncology team, either in person or via phone, as appropriate. The study nurses will contact the supervising team in between meetings for any urgent issues or questions that arise. Receives: Other: Geriatric Oncology Collaborative Care |
| Usual Care | Active comparator | Participants assigned to receive usual oncology care will not meet with the study nurses, though they may receive geriatric or palliative care consults at their request or at the discretion of their treating oncologist. 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 demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).
Measured: 3 years
Secondary outcomes (15)
Rates of study completion
To demonstrate feasibility, investigators will calculate rates of study completion (the proportion of participants who complete all study outcome assessments).
Measured: 3 years
Change in Quality of Life
Compare change in QOL (measured with the Functional Assessment of Cancer Therapy (FACT) - General) between treatment groups from baseline to 4 and 6 months.
Measured: 6 Months
Longitudinal effects of the intervention on Quality of Life
To determine longitudinal effects of the intervention on QOL (measured with the Functional Assessment of Cancer Therapy (FACT) - General), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in QOL across multiple time points (e.g. baseline, four months, and six months).
Measured: 6 months
Change in Symptom Burden
Compare change in symptom burden Burden (measured with the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups from baseline to 4 and 6 months.
Measured: 6 months
Longitudinal effects of the intervention on Symptom Burden
To determine longitudinal effects of the intervention on symptom burden (measured with the Edmonton Symptom Assessment System-revised (ESAS-r)), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in symptom burden across multiple time points (e.g. baseline, four months, and six months).
Measured: 6 months
Change in depression symptoms
Compare change in depression symptoms (measured with the 15-item Geriatric Depression Scale (GDS) with higher scores indicating greater depressive symptoms) between treatment groups from baseline to 4 and 6 months.
Measured: 6 months
Longitudinal effects of the intervention on Depression Symptoms
To determine longitudinal effects of the intervention on depression symptoms (measured with the Geriatric Depression Scale (GDS)), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in depression symptoms across multiple time points (e.g. baseline, four months, and six months).
Measured: 6 months
Cange in psychological distress
Compare change in psychological distress (measured with the PHQ-4) between treatment groups from baseline to 4 and 6 months.
Measured: 6 months
Longitudinal effects of the intervention on psychological distress
To determine longitudinal effects of the intervention on psychological distress (measured with the PHQ-4), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in psychological distress across multiple time points (e.g. baseline, four months, and six months).
Measured: 6 months
Change in Activities of Daily Living
Compare change in Activities of Daily Living (measured with the Medical Outcomes Study) between treatment groups from baseline to 4 and 6 months.
Measured: 6 months
Longitudinal effects of the intervention on Activities of Daily Living
To determine longitudinal effects of the intervention on Activities of Daily Living (measured with the Medical Outcomes Study), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in Activities of Daily Living across multiple time points (e.g. baseline, four months, and six months).
Measured: 6 months
Change in Instrumental Activities of Daily Living
Compare change in Instrumental Activities of Daily Living (measured with the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups from baseline to 4 and 6 months.
Measured: 6 months
Longitudinal effects of the intervention on Instrumental Activities of Daily Living
To determine longitudinal effects of the intervention on Instrumental Activities of Daily Living (measured with the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)), investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in Instrumental Activities of Daily Living across multiple time points (e.g. baseline, four months, and six months).
Measured: 6 months
Change in number of falls
Compare change in number of falls in the past 6 months between treatment groups from baseline to 4 and 6 months.
Measured: 6 months
Longitudinal effects of the intervention on number of falls
To determine longitudinal effects of the intervention on number of falls in the past 6 months, investigators will use mixed effects models, accounting for repeated measures data and adjusting for relevant covariates (e.g. age and sex) when examining change between groups in number of falls in the past 6 months across multiple time points (e.g. baseline, four months, and six months).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start14 Feb 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ryan Nipp, Massachusetts General Hospital
- Investigators
- Ryan D. Nipp, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721926
- Sponsor's protocol ID
- 18-389
- Other IDs
- K12CA087723
- Status last verified
- Apr 2022
- First submitted
- 19 Oct 2018
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Geriatric Oncology Collaborative Care Intervention for Older Adults With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03721926
- Acronym / sponsor ID
- 18-389
- Conditions
- Other Cancer
- Keywords
- Other Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 26 Oct 2018 (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.
The purpose of this research study is to develop a geriatric oncology collaborative care intervention to enhance the quality of life, symptom burden, and functional outcomes of older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancers.
Detailed description
Cancer disproportionately affects older adults, and the number of older adults with cancer is expected to grow as the population ages. Older adults with advanced cancer often possess a distinct set of medical and psycho-social issues that makes caring for the geriatric oncology population challenging for oncologists. Currently, a critical knowledge gap exists regarding how best to deliver comprehensive cancer care targeting the unique geriatric and palliative care needs of these individuals. The investigators propose to develop a geriatric oncology collaborative care intervention to improve supportive care outcomes for older adults with advanced gastrointestinal (GI) and genitourinary (GU) cancer. GI and GU cancers are among the leading causes of cancer death in the geriatric cancer population, and patients with advanced GI and GU cancers experience a high symptom burden. The intervention will entail visits with an oncology advanced practice nurse trained to address patients' unique needs, who will meet regularly with a supervising team of geriatric, palliative care, social work, and pharmacy clinicians for feedback and iterative reevaluation of the care plan. Using nurses who are already integrated into the oncology setting represents a scalable model that addresses the workforce shortage of geriatric and palliative care clinicians. The investigators used conceptual models for collaborative care and geriatric interventions to develop an initial intervention framework, and prior research to develop a preliminary intervention manual. In Aim 1, the investigators will refine and finalize both the intervention and the intervention manual based on qualitative data from patients, caregivers, and clinicians to ensure the intervention targets the unique needs of older adults with advanced cancer. In Aim 2, the investigators will modify the intervention and study methods with an open pilot study (n=10). In Aim 3, the investigators will conduct a pilot randomized trial (n=75) to assess the feasibility and preliminary efficacy of the geriatric oncology collaborative care intervention for improving patients' QOL, symptom burden, and functional outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatric Oncology Collaborative Care | Experimental | Other: Geriatric Oncology Collaborative CarePatients receive three visits with a trained study nurse. At each visit, the study nurse will assess the patient's symptom burden, functional status, comorbid conditions, psychosocial issues, and medication use. The nurses can refer patients to specialists as needed. The study nurses will meet with a supervising support team, consisting of clinicians from geriatrics, palliative care, social work, and pharmacy to discuss each patient and review documentation. Following the team meetings, the nurses will document recommendations in the medical record and communicate with the primary oncology team, either in person or via phone, as appropriate. The study nurses will contact the supervising team in between meetings for any urgent issues or questions that arise. |
| Usual Care | Active comparator | Other: Usual CareParticipants assigned to receive usual oncology care will not meet with the study nurses, though they may receive geriatric or palliative care consults at their request or at the discretion of their treating oncologist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 or older
- Diagnosed with advanced (defined as metastatic or receiving therapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, renal, bladder, or prostate cancer within the past 8 weeks (includes patients with a new diagnosis, progression or recurrence).
- ECOG performance status of 0-2
- Ability to read and respond to questions in English
- Planning to receive care at MGH
Key exclusion criteria (1 listed)
- Uncontrolled psychiatric illness or impaired cognition
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 |
|---|---|---|
| Usual CareParticipants assigned to receive usual oncology care will not meet with the study nurses, though they may receive geriatric or palliative care consults at their request or at the discretion of their treating oncologist. | Other | Usual Care |
| Geriatric Oncology Collaborative CarePatients receive three visits with a trained study nurse. At each visit, the study nurse will assess the patient's symptom burden, functional status, comorbid conditions, psychosocial issues, and medication use. The nurses can refer patients to specialists as needed. The study nurses will meet with a supervising support team, consisting of clinicians from geriatrics, palliative care, social work, and pharmacy to discuss each patient and review documentation. Following the team meetings, the nurses will document recommendations in the medical record and communicate with the primary oncology team, either in person or via phone, as appropriate. The study nurses will contact the supervising team in between meetings for any urgent issues or questions that arise. | Other | Geriatric Oncology Collaborative Care |
Primary outcome
Rates of study enrollment
Time frame: 3 years
To demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).
15 secondary outcomes
Rates of study completion
Time frame: 3 years
Change in Quality of Life
Time frame: 6 Months
Longitudinal effects of the intervention on Quality of Life
Time frame: 6 months
Change in Symptom Burden
Time frame: 6 months
Longitudinal effects of the intervention on Symptom Burden
Time frame: 6 months
Change in depression symptoms
Time frame: 6 months
Longitudinal effects of the intervention on Depression Symptoms
Time frame: 6 months
Cange in psychological distress
Time frame: 6 months
Longitudinal effects of the intervention on psychological distress
Time frame: 6 months
Change in Activities of Daily Living
Time frame: 6 months
Longitudinal effects of the intervention on Activities of Daily Living
Time frame: 6 months
Change in Instrumental Activities of Daily Living
Time frame: 6 months
Longitudinal effects of the intervention on Instrumental Activities of Daily Living
Time frame: 6 months
Change in number of falls
Time frame: 6 months
Longitudinal effects of the intervention on number of falls
Time frame: 6 months
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 7 Apr 2022.
- 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 D. Nipp 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 Geriatric Oncology Collaborative Care in people with Other 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 5 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: finished, as of the sponsor's last update on 7 Apr 2022. 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: 3 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 7 Apr 2022.