NCT02414672

Brief Summary

The CareSTEPS intervention fills an important service gap by providing education, skills training, and support to the caregivers of advanced lung cancer patients on active treatment. The home-based delivery format will facilitate future dissemination and outreach. By empowering families with the skills they need to provide care and meet the challenges of lung cancer, this intervention holds great promise for improving caregiver quality of life (QOL), patient QOL, and the quality of palliative and supportive care services offered to patients with advanced cancer and their families.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

5.6 years

First QC Date

April 7, 2015

Last Update Submit

April 19, 2024

Conditions

Lung Cancer

Keywords

psychosocial interventionadvanced lung cancercaregiversself-care

Outcome Measures

Primary Outcomes (2)

  • Caregiver Depression

    PROMIS Depression Short Form

    8 weeks

  • Caregiver Anxiety

    PROMS Anxiety Short form

    8 weeks

Secondary Outcomes (4)

  • Caregiver burden

    8 weeks and 6 months

  • Patient emotional quality of life

    8 weeks and 6 months

  • Caregiver Depression

    6 months

  • Caregiver Anxiety

    6 months

Other Outcomes (4)

  • Patient physical quality of life

    8 weeks and 6 months

  • Caregiver Self-care behaviors

    8 weeks and 6 months

  • Caregiver Satisfaction with Care

    8 weeks and 6 months

  • +1 more other outcomes

Study Arms (2)

CareSTEPS

EXPERIMENTAL

CareSTEPS provides skills training in six domains that are central to the caregiving role: self-care, stress management, symptom management, effective communication, problem-solving, and social support.

Behavioral: CareSTEPS

Usual Medical Care (UMC)

NO INTERVENTION

Patients receive standard oncologic and generalist palliative care from their healthcare team.

Interventions

CareSTEPSBEHAVIORAL

Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist.

CareSTEPS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has stage 3B or 4 NSLC or extensive stage SCLC 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 a spouse/partner other or close family member who he/she defines as the primary caregiver
  • Patient and caregiver \> 18 years
  • Patient/caregiver has the ability to read and understand English at a sixth grade level, as determined by his/her ability to understand the consent form
  • Patient/caregiver can provide informed consent

You may not qualify if:

  • Individuals with diminished mental capacity
  • Prisoners
  • Children
  • Pregnant Women
  • Fetuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Rangel ML, Milbury K, Kayser K, Ripley RT, Kvale E, Badr H. Multisite Randomized Controlled Trial of CareSTEPS: A Supportive Care Intervention for the Family Caregivers of Patients With Advanced Lung Cancer. JTO Clin Res Rep. 2024 Oct 17;5(12):100736. doi: 10.1016/j.jtocrr.2024.100736. eCollection 2024 Dec.

    PMID: 39583146DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract 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
Hoda Badr, PhD, Assistant Professor

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 13, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations

US(1)