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

NCT02440737 | Terminated DMC

• 3 other identifiers: VICC REACH 1525NCI-2015-00470P30CA068485
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

Newly diagnosed; Cancer patient; Caregiver; Support person

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adherence to National Comprehensive Cancer Network (NCCN) guidelines, as measured by chart review (patients only)

  Up to 2 months following the end of therapy

• Referral to subspecialists

  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

  Up to 2 months following the end of therapy

• Usefulness of navigation, as measured by the Usefulness of Navigator instrument

  Up to 2 months following the end of therapy

Other Outcomes (3)

• Completion rates

  Up to 2 months following the end of therapy

• Participation rates

  Up to 2 months following the end of therapy

• Process assessment, as measured by process evaluation questionnaire

  Up to 2 months following the end of therapy

Study Arms (1)

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.

Other: Educational Intervention; Other: Follow-Up Care; Procedure: Psychosocial Assessment and Care; Other: Questionnaire Administration

Interventions

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.

Also known as: Education for Intervention, Intervention, Educational

NEST Intervention

Follow-Up Care OTHER

Complete Survivorship Care Planning session at end of treatment

NEST Intervention

Psychosocial Assessment and Care PROCEDURE

Undergo the NEST intervention

Also known as: Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial Studies, Psychosocial Support

NEST Intervention

Questionnaire Administration OTHER

Ancillary studies

NEST Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Aftercare; Psychiatric Rehabilitation

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Continuity of Patient Care; Patient Care; Therapeutics; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Rehabilitation

Study Officials

• Debra Friedman

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)