Navigated Early Survivorship Transition in Patients With Newly Diagnosed Cancer and Their Caregivers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/4/2018 |
| Start Date: | May 2015 |
| End Date: | February 2022 |
Navigated Early Survivorship Transition in Improving Survivorship Care Planning in Patients With Newly Diagnosed Cancer and Their Caregivers (NEST)
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.
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.
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.
Inclusion Criteria:
- Newly diagnosed adult cancer patients from VICC and MMC
- Caregiver of enrolled newly diagnosed adult cancer patients from VICC and MMC
- No prior history of malignancy other than non-melanoma skin cancer
- Planned treatment for stages I - III cancer
- Treatment expected to be completed within 12 months
- English speaking
Exclusion Criteria:
- Prior history of malignancy other than non-melanoma skin cancer
- Patients treated with surgery alone will not be included
- Patients whose treatment is expected to last more than 12 months
- Non-English speaking
We found this trial at
2
sites
Nashville, Tennessee 37232
Principal Investigator: Debra L. Friedman
Phone: 615-936-0638
Click here to add this to my saved trials
Nashville, Tennessee 37208
Principal Investigator: Maureen Sanderson
Phone: 615-327-5610
Click here to add this to my saved trials