NextSteps Intervention for Advanced Cancer Patients and Caregivers

NCT04885439 | Completed

• 1 other identifier: H-39002
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to test the efficacy of a psychosocial intervention to empower advanced cancer patients and their caregivers and improve their quality of life (QOL). The program, called NextSTEPS, provides skills training in six domains that are central to patient and caregiver QOL: self-care, stress management, symptom management, effective communication, problem-solving, and social support.

Conditions

Lung Cancer; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (2)

• Patient and Caregiver Depression

  Patient Reported Outcomes Measurement Information System Depression 6 item Short form

  2 months

• Patient and Caregiver Anxiety

  Patient Reported Outcomes Measurement Information System Anxiety 6 item Short form

  2 months

Secondary Outcomes (4)

• Patient and Caregiver Satisfaction with Care

  2 months, 4 months, and 6 months

• Patient Symptom Burden

  2 months, 4 months, and 6 months

• Patient and Caregiver Depression

  4 and 6 months

• Patient and Caregiver Anxiety

  4 and 6 months

Study Arms (2)

NextSteps Intervention

EXPERIMENTAL

Patients and caregivers will each receive their own tailored manual and six weekly 45-minute telephone calls that correspond to the manual, delivered by a Masters level trained interventionist.

Behavioral: NextSteps

Usual Medical Care

NO INTERVENTION

UMC consists of standard oncologic care for the patient from the point of diagnosis of advanced cancer.

Interventions

NextSteps BEHAVIORAL

Intervention sessions are delivered by a Masters level trained interventionist. During sessions, the interventionist will: conduct the weekly symptom screen, review content, answer questions, ensure skills mastery through homework review, and work with participants to develop action plans and identify/overcome barriers to self-care/caregiving. Patients and caregivers will receive individual calls from the interventionist for sessions 1, 2, and 3, and participate together for sessions 4, 5, and 6 via speakerphone.

NextSteps Intervention

Eligibility Criteria

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

You may qualify if:

• Patient has stage 3A, 3B, or 4 NSLC or extensive stage SCLC and is within one month of treatment initiation OR patient has Stage 4 GI cancer and is within one month of treatment initiation
• patient is spending more than 50% of time out of bed on a daily basis as measured by an ECOG Performance Status rating of level 0, 1, or 2
• patient has stable brain metastases and no limitation on hepatic or renal function
• patient has a spouse/partner other or close family member who he/she defines as the primary caregiver
• patient and caregiver are age 18 years or older
• patient and caregiver have the ability to read and understand English at a sixth grade level, as determined by ability to understand the consent form
• patient and caregiver can provide informed consent

You may not qualify if:

• patient or caregiver is deaf or has significant hearing impairment and thus cannot use the telephone
• patient is currently enrolled in hospice.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Hoda Badr, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 13, 2021
• Study Start: July 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: June 30, 2021
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

US (1)