Outcomes of Triaged Family Care in Advanced Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose of this study is to: 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 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.

Official Title
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Outcomes of Triaged Family Care in Advanced Cancer

Conditions
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Advanced Cancer

Intervention / Treatment
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* Behavioral: Brief FOCUS Program
* Behavioral: Extensive FOCUS Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief<br>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. | Behavioral: Brief FOCUS Program<br>* Dyads randomized to this arm received the FOCUS Brief Program, two home visits and one phone call by a trained nurse.<br>* Other names: Cancer Patient and Family Member Intervention;|
| Experimental: Extensive<br>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. | Behavioral: Extensive FOCUS Program<br>* Dyads randomized to this arm received the FOCUS Extensive Program, 4 home visits and two phone calls by a trained nurse.<br>* Other names: Cancer Patient and Family Member Intervention;|
| No Intervention: Control<br>Dyads randomized to CONTROL arm continued with standard clinical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life |  | Baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk for Distress |  | Baseline | 
| Change in Emotional Distress |  | Baseline, 3 and 6 months | 
| Change in Appraisal of Illness/Caregiving |  | Baseline, 3 and 6 months | 
| Change in Uncertainty |  | Baseline, 3 and 6 months | 
| Change in Hopelessness |  | Baseline, 3 and 6 months | 
| Change in Self-efficacy |  | Baseline, 3 and 6 months | 
| Change in Benefits of Illness |  | Baseline, 3 and 6 months | 
| Change in Family Communication |  | Baseline, 3 and 6 months | 
| Change in Support |  | Baseline, 3 and 6 months | 
| Change in Depression |  | Baseline, 3 and 6 months | 
| Change in Coping |  | Baseline, 3 and 6 months | 
| Change in Health Care Resource Utilization |  | Baseline, 3 and 6 months | 
| Change in Caregiver Burden |  | Baseline, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Randomized Clinical Trial, Advanced Cancer, Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, Family caregiver, cancer survivorship, coping, communication, uncertainty, support, depression, self-efficacy, benefits of illness, Caregivers