Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer

NCT ID: NCT00827333

Last Updated: 2016-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

I. Test the effects of a family caregiver palliative care intervention (FCPCI) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (FC) in a usual care situation.

II. Test the effects of a FCPCI for informal caregivers of patients with early and late stage lung cancer on FC in a usual care situation.

III. Describe early and late stage FC self care behavior, comparing the usual care and FCPCI groups.

IV. Describe resource use by early and late stage FC comparing the usual care and FCPCI groups. V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.

V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.

OUTLINE: Family caregivers (FC) are assigned to 1 of 2 groups.

GROUP I: FC complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use.

GROUP II: FC undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of FC distress; social and spiritual needs of the patient and FC; the continuing role of the FC in caring for the patient; and development of a personalized wellness plan. FC then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. FC also complete questionnaires as in group I.

After completion of the educational intervention, a sample of FC undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Phase I-Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Phase 2 - Intervention

Group Type ACTIVE_COMPARATOR

educational intervention

Intervention Type OTHER

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

questionnaire administration

Intervention Type OTHER

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

end-of-life treatment/management

Intervention Type PROCEDURE

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

psychosocial assessment and care

Intervention Type PROCEDURE

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

quality-of-life assessment

Intervention Type PROCEDURE

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

Interventions

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educational intervention

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

Intervention Type OTHER

questionnaire administration

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

Intervention Type OTHER

end-of-life treatment/management

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

Intervention Type PROCEDURE

psychosocial assessment and care

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

Intervention Type PROCEDURE

quality-of-life assessment

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Betty Ferrell, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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P01CA136396

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-08036

Identifier Type: -

Identifier Source: secondary_id

CDR0000631261

Identifier Type: REGISTRY

Identifier Source: secondary_id

08036

Identifier Type: -

Identifier Source: org_study_id

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