CancerNCT00253383
Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients
A study testing counseling intervention, educational intervention and psychosocial assessment and care in people with Cancer, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Palliative care may help patients with advanced cancer live more comfortably. PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- counseling intervention, educational intervention and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to Sep 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following advanced cancers:
- Stage IIIB or IV non-small cell lung cancer
- Extensive stage small cell lung cancer
- Stage IV breast cancer
- Poor prognostic indicators (conferring likelihood of ≤ 2 years survival), including, but not limited to, any of the following:
- Visceral crisis
- Lung or liver metastasis
- Estrogen receptor-negative disease
- HER2/neu-positive disease
- Progressive or recurrent disease during or within 2 years of first treatment
- Unresectable stage III or stage IV gastrointestinal cancers
- Stage IV genitourinary cancers
- Prostate cancer must be hormone refractory
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Sex
- Not specified
Menopausal status
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No dementia or significant confusion (i.e., Mini Mental Exam score < 25)
- No Axis I psychiatric disorders (DSM-IV), including any of the following:
- Schizophrenia
- Bipolar disorder
- Active substance use disorder
PRIOR CONCURRENT THERAPY:
Endocrine therapy
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
About this study
Official title: Improving Palliative Care for Patients With Cancer
RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.
PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of an early intervention palliative care program comprising a phone-based nurse educator and shared medical appointments in improving end-of-life care of patients with advanced lung, gastrointestinal, genitourinary, or breast cancer.
- Compare symptom management, quality of life, and the match between preference of care and the care received in patients treated with an early intervention palliative care program vs a standard care program.
- Compare health care utilization by patients treated with these interventions.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cancer diagnosis (lung vs breast vs gastrointestinal vs genitourinary) and participating center. Patients are randomized to 1 of 2 intervention arms.
- Arm I (early-intervention palliative care program): Patients complete the Medical Care Questionnaire and receive a computer-generated prescription letter that outlines the problems they have identified; the patient's physician also receives a copy of the letter. Patients receive a series of phone calls weekly for 4 weeks and then at least monthly from a nurse educator. The phone calls address 3 major areas: coordination of palliative care options in the cancer center and the patient's community, including referrals for psychological or spiritual counseling, social work consultation, financial guidance, home health, palliative care or hospice services, and bereavement counseling for the family; problem-solving therapy, focusing on the identification of problems, definition of achievable goals, a plan for reaching those goals, and evaluation of success; and tailored psycho-educational modules from "Charting Your Course", covering end-of-life topics such as symptom management, advanced care planning, communication with the health care team and family members, spirituality, and nutrition. Patients also receive information regarding the purpose and time/location of symptom management, shared medical appointments (SMAs), which they can attend in person or call in to participate via speaker phone. SMAs are 1.5-hour monthly sessions conducted by a physician and a nurse practitioner that can accommodate 10-12 patients and their caregivers. The sessions include a welcome/social period, a question and answer/peer discussion, an interactive educational session, and an opportunity for one-on-one nurse practitioner appointments with a focus on a brief review of the patients' medical treatment plans.
- Arm II (standard palliative care program): Patients receive standard palliative care from their physician/nurse practitioner team and have access to the palliative care nurse at the discretion of the treating physician.
Patients complete Functional Assessment of Chronic Illness Therapy-Palliative Care at baseline and every 3 months thereafter. Patients and caregivers complete surveys measuring their perception of the quality of the patient's cancer care at baseline and at 1 month.
A caregiver or family member completes the After-Death Bereaved Family Member Interview to evaluate the adequacy of patient care at 3 months post-patient death.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
- Conditions
- Cancer
- Being tested
- counseling intervention, educational intervention, psychosocial assessment and care, quality-of-life assessment
- Keywords
- transitional care planning, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, stage IV breast cancer, recurrent breast cancer, male breast cancer, stage IIIB anal cancer, stage IV anal cancer, carcinoma of the appendix, stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, stage III esophageal cancer, stage IV esophageal cancer, unresectable extrahepatic bile duct cancer, unresectable gallbladder cancer, stage III gastric cancer, stage IV gastric cancer
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Breast Neoplasms, Male, Anus Neoplasms, Appendiceal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
educational interventionOther
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ENABLE (concurrent palliative care) | Experimental | telephone based ENABLE educational intervention Receives: Other: counseling intervention; Other: educational intervention; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment |
| Usual Care | Active comparator | Supportive and palliative usual care services at DHMC, Behavioral Receives: Other: counseling intervention; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter
Measured: Baseline, one month, every three months
Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter
Measured: Baseline, one month, every three months
Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter
Measured: Baseline, one month, every three months
Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased
Measured: Baseline, one month, every three months
Secondary outcomes (3)
Depression as measured by Center for Epidemiological Studies-Depression (CES-D) at baseline, one month, and every three months thereafter
Measured: Baseline, one month, every three months
Problem solving skills as measured by Social Problem-Solving Skills Inventory-revised at baseline and one month
Measured: Baseline, one month, every three months
Caregiver burden as measured by Montgomery-Borgatta Caregiver Burden Scale at baseline, one month, and every three months thereafter (given to caregivers of patients)
Measured: Baseline, one month, every three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJan 2003
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical 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
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marie A Bakitas, PhD, Principal investigator, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253383
- Sponsor's protocol ID
- CDR0000452966
- Other IDs
- R01CA101704, P30CA023108, DMS-0226, DMS-CPHS-16004
- Status last verified
- Dec 2014
- First submitted
- 11 Nov 2005
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
PubMed 19690306Corn BW, Feldman DB, Hull JG, O'Rourke MA, Bakitas MA. Dispositional hope as a potential outcome parameter among patients with advanced malignancy: An analysis of the ENABLE database. Cancer. 2022 Jan 15;128(2):401-409. doi: 10.1002/cncr.33907. Epub 2021 Oct 6.
PubMed 34613617Prescott AT, Hull JG, Dionne-Odom JN, Tosteson TD, Lyons KD, Li Z, Li Z, Dragnev KH, Hegel MT, Steinhauser KE, Ahles TA, Bakitas MA. The role of a palliative care intervention in moderating the relationship between depression and survival among individuals with advanced cancer. Health Psychol. 2017 Dec;36(12):1140-1146. doi: 10.1037/hea0000544. Epub 2017 Oct 19.
PubMed 29048177
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Palliative Care for Patients With Cancer
- ClinicalTrials.gov ID
- NCT00253383
- Acronym / sponsor ID
- CDR0000452966
- Conditions
- Cancer
- Keywords
- transitional care planning, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, stage IV breast cancer, recurrent breast cancer, male breast cancer, stage IIIB anal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2003
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Nov 2005 (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.
RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.
PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of an early intervention palliative care program comprising a phone-based nurse educator and shared medical appointments in improving end-of-life care of patients with advanced lung, gastrointestinal, genitourinary, or breast cancer.
- Compare symptom management, quality of life, and the match between preference of care and the care received in patients treated with an early intervention palliative care program vs a standard care program.
- Compare health care utilization by patients treated with these interventions.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cancer diagnosis (lung vs breast vs gastrointestinal vs genitourinary) and participating center. Patients are randomized to 1 of 2 intervention arms.
- Arm I (early-intervention palliative care program): Patients complete the Medical Care Questionnaire and receive a computer-generated prescription letter that outlines the problems they have identified; the patient's physician also receives a copy of the letter. Patients receive a series of phone calls weekly for 4 weeks and then at least monthly from a nurse educator. The phone calls address 3 major areas: coordination of palliative care options in the cancer center and the patient's community, including referrals for psychological or spiritual counseling, social work consultation, financial guidance, home health, palliative care or hospice services, and bereavement counseling for the family; problem-solving therapy, focusing on the identification of problems, definition of achievable goals, a plan for reaching those goals, and evaluation of success; and tailored psycho-educational modules from "Charting Your Course", covering end-of-life topics such as symptom management, advanced care planning, communication with the health care team and family members, spirituality, and nutrition. Patients also receive information regarding the purpose and time/location of symptom management, shared medical appointments (SMAs), which they can attend in person or call in to participate via speaker phone. SMAs are 1.5-hour monthly sessions conducted by a physician and a nurse practitioner that can accommodate 10-12 patients and their caregivers. The sessions include a welcome/social period, a question and answer/peer discussion, an interactive educational session, and an opportunity for one-on-one nurse practitioner appointments with a focus on a brief review of the patients' medical treatment plans.
- Arm II (standard palliative care program): Patients receive standard palliative care from their physician/nurse practitioner team and have access to the palliative care nurse at the discretion of the treating physician.
Patients complete Functional Assessment of Chronic Illness Therapy-Palliative Care at baseline and every 3 months thereafter. Patients and caregivers complete surveys measuring their perception of the quality of the patient's cancer care at baseline and at 1 month.
A caregiver or family member completes the After-Death Bereaved Family Member Interview to evaluate the adequacy of patient care at 3 months post-patient death.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENABLE (concurrent palliative care) | Experimental | Other: counseling intervention, Other: educational intervention, Procedure: psychosocial assessment and care, Procedure: quality-of-life assessmenttelephone based ENABLE educational intervention |
| Usual Care | Active comparator | Other: counseling intervention, Procedure: psychosocial assessment and care, Procedure: quality-of-life assessmentSupportive and palliative usual care services at DHMC, Behavioral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| counseling intervention | Other | ENABLE (concurrent palliative care), Usual Care |
| educational intervention | Other | ENABLE (concurrent palliative care) |
| psychosocial assessment and care | Procedure or surgery | ENABLE (concurrent palliative care), Usual Care |
| quality-of-life assessment | Procedure or surgery | ENABLE (concurrent palliative care), Usual Care |
Primary outcome
Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter
Time frame: Baseline, one month, every three months
Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter
Time frame: Baseline, one month, every three months
Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter
Time frame: Baseline, one month, every three months
Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased
Time frame: Baseline, one month, every three months
3 secondary outcomes
Depression as measured by Center for Epidemiological Studies-Depression (CES-D) at baseline, one month, and every three months thereafter
Time frame: Baseline, one month, every three months
Problem solving skills as measured by Social Problem-Solving Skills Inventory-revised at baseline and one month
Time frame: Baseline, one month, every three months
Caregiver burden as measured by Montgomery-Borgatta Caregiver Burden Scale at baseline, one month, and every three months thereafter (given to caregivers of patients)
Time frame: Baseline, one month, every three 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 19 Dec 2014.
- Results publication: PubMed 19690306Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
- Derived from this study: PubMed 34613617Corn BW, Feldman DB, Hull JG, O'Rourke MA, Bakitas MA. Dispositional hope as a potential outcome parameter among patients with advanced malignancy: An analysis of the ENABLE database. Cancer. 2022 Jan 15;128(2):401-409. doi: 10.1002/cncr.33907. Epub 2021 Oct 6.
- Derived from this study: PubMed 29048177Prescott AT, Hull JG, Dionne-Odom JN, Tosteson TD, Lyons KD, Li Z, Li Z, Dragnev KH, Hegel MT, Steinhauser KE, Ahles TA, Bakitas MA. The role of a palliative care intervention in moderating the relationship between depression and survival among individuals with advanced cancer. Health Psychol. 2017 Dec;36(12):1140-1146. doi: 10.1037/hea0000544. Epub 2017 Oct 19.
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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.
Marie A Bakitas, PhD principal investigator
Norris Cotton Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, educational intervention and psychosocial assessment and care in people with Cancer, run by Dartmouth-Hitchcock Medical Center at 2 sites 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?
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 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter (time frame: Baseline, one month, every three months). The study lists 4 primary outcomes in all. 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 NCT00253383, which also lists 3 linked publications.
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 19 Dec 2014.