Navigated Early Survivorship Transition in Patients With Newly Diagnosed Cancer and Their Caregivers (NEST)

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention; Other: Follow-Up Care; Procedure: Psychosocial Assessment and Care

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University/Ingram Cancer Center
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NEST Intervention; 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.

Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; 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.; Other Names: Education for Intervention; Intervention, Educational; Other: Follow-Up Care; Complete Survivorship Care Planning session at end of treatment; Procedure: Psychosocial Assessment and Care; Undergo the NEST intervention; Other Names: Psychosocial Assessment; Psychosocial Care; Psychosocial Care/Assessment; Psychosocial Studies; Psychosocial Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debra Friedman, Vanderbilt University/Ingram Cancer Center

Publications and helpful links

Helpful Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Caregiver; Newly diagnosed; Cancer patient; Support person
• Other Study ID Numbers: VICC REACH 1525 (Other Identifier: VICC (Vanderbilt Ingram Cancer Center)); P30CA068485 (U.S. NIH Grant/Contract); NCI-2015-00470 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO