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

Cancer Clinical Trial

— NEST  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02440737
• Other study ID #: VICC REACH 1525
• Secondary ID: NCI-2015-00470VI
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2019
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• Follow-Up Care
Complete Survivorship Care Planning session at end of treatment

Procedure:
• Psychosocial Assessment and Care
Undergo the NEST intervention

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Meharry Medical College	Nashville	Tennessee
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial