Clinical trial NCT02440737: Navigated Early Survivorship Transition in Patients With Newly Diagnosed Cancer and Their Caregivers
Official title: Navigated Early Survivorship Transition in Improving Survivorship Care Planning in Patients With Newly Diagnosed Cancer and Their Caregivers (NEST)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: Newly diagnosed
Cancer patient
Caregiver
Support person
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-05-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 2 months following the end of therapy
Secondary outcomes:
measure: Adherence to National Comprehensive Cancer Network (NCCN) guidelines, as measured by chart review (patients only)
timeFrame: Up to 2 months following the end of therapy
measure: Referral to subspecialists
timeFrame: Up to 2 months following the end of therapy
measure: Resource utilization, as measured by the Effectiveness in Obtaining Resources Scale and the Cancer Resource Survey
timeFrame: Up to 2 months following the end of therapy
measure: Usefulness of navigation, as measured by the Usefulness of Navigator instrument
timeFrame: Up to 2 months following the end of therapy
Other outcomes:
measure: Completion rates
timeFrame: Up to 2 months following the end of therapy
measure: Participation rates
timeFrame: Up to 2 months following the end of therapy
measure: Process assessment, as measured by process evaluation questionnaire
timeFrame: Up to 2 months following the end of therapy
Locations:
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Debra Friedman
role: PRINCIPAL_INVESTIGATOR
References: