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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00470 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VICC REACH 1525 | Other Identifier | VICC (Vanderbilt Ingram Cancer Center) | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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Slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies the Navigated Early Survivorship Transition (NEST) intervention in improving survivorship care planning in patients with newly diagnosed cancer and their caregivers. A survivorship care planning session (SCPS) delivered to survivors and their primary caregivers may improve psychosocial well-being, patient and caregiver engagement, and adherence to treatment and follow-up recommendations. It is not yet known whether a NEST intervention or usual care is better in improving survivorship care planning in patients with newly diagnosed cancer.
PRIMARY OBJECTIVES:
I. In a new model of survivorship care planning, planning started within the first two months of therapy, followed by additional survivorship care planning at the end of therapy or 6 months post diagnosis, evaluate the proportion of eligible survivors and participating caregivers who complete the survivorship care planning.
II. In a feasibility study of survivors and their identified support caregivers (70 survivors with or with a participating caregiver at VICC and 70 survivors with or without a participating caregiver at MMC), evaluate psychosocial well-being, engagement, resource utilization and adherence to recommended treatment and follow-up guidelines.
III. Assess the outcomes of survivors and participating caregivers treated at VICC and MMC to further individualize survivorship planning that will incorporate the optimal timing and content together with socioeconomic and cultural considerations. The pillars of this novel intervention (i.e., survivorship care planning, psychosocial assessment and patient engagement) are responsive to the recommendations of the IOM. The project proposed herein will build directly upon our work in the P20 grant and will set the stage for the planned R01 RCT, which would be directly responsive to NCI PAR 12-275. The ultimate aim is to inform best practices in survivorship planning in community and academic cancer centers, serving diverse, including underserved minority populations, with sufficient power to detect differences between treatment groups.
OUTLINE: Patients and their caregivers participate in an upfront survivorship care planning session.
Patients and their caregivers meet with the Survivorship Nurse Practitioner (NP) at the VICC or the Nurse Navigator (NN) at MMC during an initial survivorship care planning session (30 minutes total) to identify resources that may be needed during and following therapy. The patient and their caregiver then meet together with the NP or NN (60 minutes total) to discuss the planned therapy, the expected course of recovery and recommendations for follow-up, and are provided with a preliminary survivorship care plan (SCP). Caregivers also receive the National Cancer Institute publication, "When Someone You Love is Being Treated for Cancer". Patients and their caregivers proceed with therapy. At the end of therapy, patients and their caregivers schedule a one-hour visit with the NP or NN for a booster survivorship care planning session (SCPS). At this booster session, they will review the questionnaires and receive an individualized final SCPS and the "REACH for Survivorship" handbook.
After completion of treatment for cancer, patients and their caregivers complete follow up assessments at the end of treatment and again two months after the end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEST Intervention | Experimental | Patients (PTs) and their caregivers (CGs) receive educational intervention, follow-up care, psychosocial assessment and care, and questionnaire administration interventions by completing psychosocial questionnaires and meeting with a nurse practitioner (NP) or nurse navigator (NN) for an initial survivorship care planning session to review the expected course of therapy and recovery, identify resources that may be needed and provide recommendations for follow-up. At the end of their treatment EOT), PTs and their CGs complete a 2nd set of questionnaires and meet with the NP/NN for a booster survivorship care planning session. They will receive an individualized final survivorship care plan and related materials. 2 months after EOT, PTs and their CGs complete a final set of questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive publication, "When Someone You Love is Being Treated for Cancer", a preliminary individualized Survivorship Care Plan (SCP), a final individualized SCP, and the "REACH for Survivorship" handbook. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and caregiver engagement, measured by the PHQ, IES-R, Distress Thermometer, & Effective Consumer Scale-17 & Psychosocial well-being, measured by the Patient Health Questionnaire (PHQ), Impact of Event Scale-Revised (IES-R), & Distress Thermometer | Will be compared between participants (patients and caregivers) and between those treated at VICC and MMC. Will use continuous scores on the depression, anxiety, and somatic symptom scales for the primary analyses; supplemental analyses will examine the percentage of patients above and below the recommended clinical cut-offs on these scales before and after the interventions. Will develop a regression model with the treatment group as the primary variable of interest. | Up to 2 months following the end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to National Comprehensive Cancer Network (NCCN) guidelines, as measured by chart review (patients only) | Will develop a regression model with the treatment group as the primary variable of interest. | Up to 2 months following the end of therapy |
| Referral to subspecialists |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rates | Will be descriptive. Will develop a regression model with the treatment group as the primary variable of interest. Will conduct univariable tests of significance using chi-squared tests. | Up to 2 months following the end of therapy |
| Participation rates |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Friedman | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meharry Medical College | Nashville | Tennessee | 37208 | United States | ||
| Vanderbilt University/Ingram Cancer Center |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| Follow-Up Care | Other | Complete Survivorship Care Planning session at end of treatment |
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| Psychosocial Assessment and Care | Procedure | Undergo the NEST intervention |
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| Questionnaire Administration | Other | Ancillary studies |
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Will develop a regression model with the treatment group as the primary variable of interest. |
| Up to 2 months following the end of therapy |
| Resource utilization, as measured by the Effectiveness in Obtaining Resources Scale and the Cancer Resource Survey | Will develop a regression model with the treatment group as the primary variable of interest. | Up to 2 months following the end of therapy |
| Usefulness of navigation, as measured by the Usefulness of Navigator instrument | Will develop a regression model with the treatment group as the primary variable of interest. | Up to 2 months following the end of therapy |
Will be descriptive. Will develop a regression model with the treatment group as the primary variable of interest. Will conduct univariable tests of significance using chi-squared tests. |
| Up to 2 months following the end of therapy |
| Process assessment, as measured by process evaluation questionnaire | Will be descriptive. Will develop a regression model with the treatment group as the primary variable of interest. Will conduct univariable tests of significance using chi-squared tests. | Up to 2 months following the end of therapy |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D000359 | Aftercare |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D012046 | Rehabilitation |
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