NCT00827333

Brief Summary

RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer. PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Sep 2009

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

First Submitted

Initial submission to the registry

January 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

5 years

First QC Date

January 21, 2009

Last Update Submit

July 29, 2016

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (7)

  • Caregiver burden

    24 weeks post study enrollment

  • Caregiver skills preparedness

    24 weeks post study enrollment

  • Caregiver quality of life

    24 weeks post study enrollment

  • Caregiver psychological distress

    24 weeks post study enrollment

  • Caregiver self-care behavior

    24 weeks post study enrollment

  • Resource use by caregiver

    24 weeks post study enrollment

  • Identification of a subgroup of caregivers who benefit most from the family caregiver palliative care intervention in relation to sociodemographic characteristics and clinical/functional factors

    24 weeks post study enrollment

Study Arms (2)

Phase I-Usual Care

NO INTERVENTION

Phase 2 - Intervention

ACTIVE COMPARATOR
Other: educational interventionOther: questionnaire administrationProcedure: end-of-life treatment/managementProcedure: psychosocial assessment and careProcedure: quality-of-life assessment

Interventions

educational interventionOTHER

Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment

Phase 2 - Intervention
questionnaire administrationOTHER

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

Phase 2 - Intervention
end-of-life treatment/managementPROCEDURE

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

Phase 2 - Intervention
psychosocial assessment and carePROCEDURE

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

Phase 2 - Intervention
quality-of-life assessmentPROCEDURE

Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment

Phase 2 - Intervention

Eligibility Criteria

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

You may qualify if:

  • The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2
  • Patients having been accrued to project 1 or project 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Early Intervention, EducationalTherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesRehabilitation

Study Officials

  • Betty Ferrell, PhD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 22, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 2, 2016

Record last verified: 2016-07

Locations

US(1)