CancerNCT02868112
Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer
A study testing Usual Oncology Care and Transdisciplinary Intervention in people with Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to pilot test a transdisciplinary intervention that integrates both geriatrics and palliative care with routine oncology care for older adults with incurable cancer. The investigators will explore their perceptions of the supportive care needs of older patients with cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Usual Oncology Care and Transdisciplinary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 20 Dec 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 incurable (defined as metastatic or receiving chemotherapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, or lung cancer within the prior 8 weeks (including patients with prior diagnosis of cancer who developed incurable disease)
- Verbal fluency in English
- Planning to receive care at Massachusetts General Hospital (MGH)
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
- No medical problems for geriatric clinician to address (e.g. comorbidities, polypharmacy, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts general Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study Of A Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer
The purpose of this research study is to pilot test a transdisciplinary intervention that integrates both geriatrics and palliative care with routine oncology care for older adults with incurable cancer. The investigators will explore their perceptions of the supportive care needs of older patients with cancer. Using these data, the investigators will finalize the transdisciplinary intervention and perform a pilot, randomized trial of the transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed, incurable cancer.
Read the detailed description
While evidence suggests that older adults with incurable cancer have unique geriatric and palliative care needs, models of care that are focused on these needs are lacking. The investigators propose to pilot test an intervention targeting the geriatric and palliative care needs of older adults with incurable cancer, referred to as a "transdisciplinary intervention."
The goals of the proposed study are: (1) conduct focus groups with clinicians (from oncology, geriatrics and palliative care) and interviews with patients to explore their perceptions of older patients' supportive care needs and finalize the transdisciplinary intervention; (2) to demonstrate the feasibility and acceptability of delivering the transdisciplinary intervention to older patients with incurable GI and lung cancers; and (3) to estimate the effect size of the transdisciplinary intervention for patient-reported outcomes (e.g., between-group differences from baseline to week 12 in quality of life, physical function, physical and psychological symptoms).
- Conditions
- Cancer
- Being tested
- Usual Oncology Care, Transdisciplinary Intervention
- Keywords
- Cancer Care, Palliative Care, Geriatrics, Quality of Life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Oncology CareOther
Participants receiving usual oncology care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team.
Transdisciplinary InterventionOther
Patients randomized to the transdisciplinary intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool, completed prior to their visit. We will test a two-visit transdisciplinary intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit.
| Study group | Role | What they receive |
|---|---|---|
| Transdisciplinary Intervention | Experimental | Patients randomized to the Transdisciplinary Intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool.
-Investigators will test a two-visit Transdisciplinary Intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit. Receives: Other: Transdisciplinary Intervention |
| Usual Care | Active comparator | Participants receiving Usual Oncology Care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team. Receives: Other: Usual Oncology Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions of the necessary components of a transdisciplinary intervention integrating geriatrics and palliative care with oncology care for older patients with incurable GI and lung cancers.
We will use qualitative assessment methods to characterize the sample and explore participant perceptions of the supportive care needs of older patients with cancer.
Measured: 2 years
Secondary outcomes (15)
Rates of study enrollment (proportion of eligible patients who enroll in the study).
To demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).
Measured: 18 Months
Rates of study completion (the proportion of participants who complete both study visits).
To demonstrate feasibility, investigators will calculate rates of study completion (the proportion of participants who complete both study visits).
Measured: 18 Months
Mean change in Quality of Life (measured with the Functional Assessment of Cancer Therapy (FACT) - General) scores between treatment groups from baseline to week 12.
We will compare mean change in QOL scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Mean change in symptom scores (measured continuously with the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups from baseline to week 12.
We will compare mean change in symptom scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Mean change in depression scores (measured continuously with the Geriatric Depression Scale (GDS)) between treatment groups from baseline to week 12.
We will compare mean change in depression scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Rates of post-intervention moderate/severe symptoms (measured as presence or absence of moderate/severe symptoms using the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups.
We will compare rates of post-intervention moderate/severe symptoms (defined as ESAS scores ≥4) between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Rates of post-intervention depression symptoms (measured as presence or absence of depression symptoms using the Geriatric Depression Scale (GDS)) between treatment groups.
We will compare rates of post-intervention depression symptoms (defined as GDS scores > 5) between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Mean change in activities of daily living (measured continuously using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups from baseline to week 12.
We will compare mean change in activities of daily living between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Mean change in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups from baseline to week 12.
We will compare mean change in instrumental activities of daily living between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Mean change in illness perceptions (measured continuously using the Brief Illness Perceptions Questionnaire (BIPQ)) between treatment groups from baseline to week 12.
We will compare mean change in illness perceptions between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Mean change in self-efficacy (measured continuously using the Perceived Efficacy in Patient-Physician Interactions (PEPPI)) between treatment groups from baseline to week 12.
We will compare mean change in self-efficacy between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Rates of post-intervention deficits in activities of daily living (measured as presence or absence of deficits in activities of daily living using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups.
We will compare rates of post-intervention deficits in activities of daily living between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Rates of post-intervention deficits in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups.
We will compare rates of post-intervention deficits in instrumental activities of daily living between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline to week 12
Rates of hospice enrollment prior to death (measured as rates of hospice enrollment prior to death) between treatment groups.
We will compare rates of hospice enrollment prior to death between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
Measured: From Baseline until Death, assessed up to 5 years
Acceptability of the Transdisciplinary Intervention To Older Patients With Incurable GI And Lung Cancers.
Investigators will evaluate acceptability using exit assessment data. Participants will rate their satisfaction with the structure, timing and content of the intervention, using Likert-type scale responses.
Investigators will calculate individual item response frequencies using descriptive statistics to summarize acceptability of different intervention components.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startOct 2016
- Primary completion1 Oct 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Collaborators
- National Institute on Aging (NIA)
- 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
- NCT02868112
- Sponsor's protocol ID
- 16-179
- Other IDs
- R03AG053314
- Status last verified
- Nov 2021
- First submitted
- 30 Jul 2016
- Last updated
- 23 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Of A Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer
- ClinicalTrials.gov ID
- NCT02868112
- Acronym / sponsor ID
- 16-179
- Conditions
- Cancer
- Keywords
- Cancer Care, Palliative Care, Geriatrics, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2016
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 16 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 pilot test a transdisciplinary intervention that integrates both geriatrics and palliative care with routine oncology care for older adults with incurable cancer. The investigators will explore their perceptions of the supportive care needs of older patients with cancer. Using these data, the investigators will finalize the transdisciplinary intervention and perform a pilot, randomized trial of the transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed, incurable cancer.
Detailed description
While evidence suggests that older adults with incurable cancer have unique geriatric and palliative care needs, models of care that are focused on these needs are lacking. The investigators propose to pilot test an intervention targeting the geriatric and palliative care needs of older adults with incurable cancer, referred to as a "transdisciplinary intervention."
The goals of the proposed study are: (1) conduct focus groups with clinicians (from oncology, geriatrics and palliative care) and interviews with patients to explore their perceptions of older patients' supportive care needs and finalize the transdisciplinary intervention; (2) to demonstrate the feasibility and acceptability of delivering the transdisciplinary intervention to older patients with incurable GI and lung cancers; and (3) to estimate the effect size of the transdisciplinary intervention for patient-reported outcomes (e.g., between-group differences from baseline to week 12 in quality of life, physical function, physical and psychological symptoms).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdisciplinary Intervention | Experimental | Other: Transdisciplinary InterventionPatients randomized to the Transdisciplinary Intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool. -Investigators will test a two-visit Transdisciplinary Intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit. |
| Usual Care | Active comparator | Other: Usual Oncology CareParticipants receiving Usual Oncology Care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team. |
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 incurable (defined as metastatic or receiving chemotherapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, or lung cancer within the prior 8 weeks (including patients with prior diagnosis of cancer who developed incurable disease)
- Verbal fluency in English
- Planning to receive care at Massachusetts General Hospital (MGH)
Key exclusion criteria (3 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
- No medical problems for geriatric clinician to address (e.g. comorbidities, polypharmacy, etc.)
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 Oncology CareParticipants receiving usual oncology care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team. | Other | Usual Care |
| Transdisciplinary InterventionPatients randomized to the transdisciplinary intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool, completed prior to their visit. We will test a two-visit transdisciplinary intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit. | Other | Transdisciplinary Intervention |
Primary outcome
Perceptions of the necessary components of a transdisciplinary intervention integrating geriatrics and palliative care with oncology care for older patients with incurable GI and lung cancers.
Time frame: 2 years
We will use qualitative assessment methods to characterize the sample and explore participant perceptions of the supportive care needs of older patients with cancer.
15 secondary outcomes
Rates of study enrollment (proportion of eligible patients who enroll in the study).
Time frame: 18 Months
Rates of study completion (the proportion of participants who complete both study visits).
Time frame: 18 Months
Mean change in Quality of Life (measured with the Functional Assessment of Cancer Therapy (FACT) - General) scores between treatment groups from baseline to week 12.
Time frame: From Baseline to week 12
Mean change in symptom scores (measured continuously with the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups from baseline to week 12.
Time frame: From Baseline to week 12
Mean change in depression scores (measured continuously with the Geriatric Depression Scale (GDS)) between treatment groups from baseline to week 12.
Time frame: From Baseline to week 12
Rates of post-intervention moderate/severe symptoms (measured as presence or absence of moderate/severe symptoms using the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups.
Time frame: From Baseline to week 12
Rates of post-intervention depression symptoms (measured as presence or absence of depression symptoms using the Geriatric Depression Scale (GDS)) between treatment groups.
Time frame: From Baseline to week 12
Mean change in activities of daily living (measured continuously using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups from baseline to week 12.
Time frame: From Baseline to week 12
Mean change in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups from baseline to week 12.
Time frame: From Baseline to week 12
Mean change in illness perceptions (measured continuously using the Brief Illness Perceptions Questionnaire (BIPQ)) between treatment groups from baseline to week 12.
Time frame: From Baseline to week 12
Mean change in self-efficacy (measured continuously using the Perceived Efficacy in Patient-Physician Interactions (PEPPI)) between treatment groups from baseline to week 12.
Time frame: From Baseline to week 12
Rates of post-intervention deficits in activities of daily living (measured as presence or absence of deficits in activities of daily living using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups.
Time frame: From Baseline to week 12
Rates of post-intervention deficits in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups.
Time frame: From Baseline to week 12
Rates of hospice enrollment prior to death (measured as rates of hospice enrollment prior to death) between treatment groups.
Time frame: From Baseline until Death, assessed up to 5 years
Acceptability of the Transdisciplinary Intervention To Older Patients With Incurable GI And Lung Cancers.
Time frame: 18 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 23 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 Usual Oncology Care and Transdisciplinary Intervention in people with 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 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 23 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?
Perceptions of the necessary components of a transdisciplinary intervention integrating geriatrics and palliative care with oncology care for older patients with incurable GI and lung cancers. (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 23 Nov 2021.