Outcomes of Triaged Family Care in Advanced Cancer

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prostate Cancer: Family Care for Patients and Spouses

NCT00708968

Prostate Cancer Quality of Life Cancer Survivorship

COMPLETED NA

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

NCT01846520

Healthy Subject Localized Transitional Cell Cancer of the Renal Pelvis and Ureter Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter +81 more

COMPLETED NA

Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

NCT01415089

Breast Cancer Colorectal Cancer Lung Cancer +1 more

COMPLETED NA

Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

NCT02616107

Family Caregivers

COMPLETED NA

Quality of Life of Older Patients Who Are Undergoing Treatment for Cancer and of Their Family Caregivers

NCT00255697

Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to:

1. determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care
2. determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's baseline risk for distress status (high versus low).

A longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brief

Dyads randomized to BRIEF arm received the Brief FOCUS Program (two home visits and one phone call by a trained nurse) in addition to standard clinical care.

Group Type EXPERIMENTAL

Brief FOCUS Program

Intervention Type BEHAVIORAL

Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.

Extensive

Dyads randomized to EXTENSIVE arm received the Extensive FOCUS Program (4 home visits and two phone calls by a trained nurse) in addition to standard clinical care.

Group Type EXPERIMENTAL

Extensive FOCUS Program

Intervention Type BEHAVIORAL

Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.

Control

Dyads randomized to CONTROL arm continued with standard clinical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief FOCUS Program

Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.

Intervention Type BEHAVIORAL

Extensive FOCUS Program

Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S) Family-based Intervention Cancer Patient and Family Member Intervention Family(F),Optimism(O),Coping(C),Uncertainty(U),Symptoms(S) Family-based Intervention Cancer Patient and Family Member Intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with Stage 3 or 4 breast, prostate, colorectal and lung cancers.
* Patients must be 21 years old or older, physically and mentally able to participate, speak and understand English, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study.
* For this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment.
* Family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand English.

Exclusion Criteria

* Patients will be excluded if they have multiple primary cancer sites.
* Family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No