Aim One: To determine if family dyads randomly assigned to either a brief or extended family-based program of care (The FOCUS Program) have better proximal and distal patient and caregiver outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care.

• H1: Family dyads randomized to a brief or extended family-based program of care will report better proximal outcomes and distal outcomes than family dyads that receive usual care.  
• Proximal outcomes: less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, more active coping, better family illness-communication, and higher self-efficacy.  Distal outcomes: higher quality of life, greater satisfaction with care, and similar or lower health care resource utilization.

• H2: There will be a differential effect of the family-based intervention on patients’ and caregivers’ proximal and distal outcomes, depending on the patient’s risk for distress (high versus low).
• H2.1: Among dyads in which patients report high risk for distress: extended brief usual care.
• H2.2: Among dyads in which patients report low risk for distress: extended or brief usual care.

Patients were eligible if they were diagnosed with advanced breast, colorectal, lung or prostate cancer (i.e., Stage III or IV), and were within a six-month window of having a new advanced cancer diagnosis, progression of their advanced cancer, or change of treatment for it. Eligibility also included a life expectancy six months, age 21 or older, living within 75 miles of participating cancer centers, and having a family caregiver willing to participate. Caregivers were eligible if they were age 18 or older and identified by patients as their primary caregiver (i.e., provider of emotional and/or physical care). Family caregivers were excluded if they were diagnosed with cancer in the previous year or were receiving cancer treatment.

Over four years, 906 patient-caregiver dyads were referred to the study; 484 dyads completed baseline assessments (enrollment rate 68.6%), and were randomized; 343 dyads completed Time 2 assessments (70.9% retention); and 302 dyads completed Time 3 assessments (62.4% retention).

At baseline, patients were screened for their risk for distress using the Risk for Distress Scale (RFD). Scores on the RFD > 9 were designated high risk based on our previous research. A stratified randomization process was used; dyads were stratified by patients’ risk status (high or low), type of cancer (breast, colorectal, lung, prostate), and research site (four sites), and then randomly assigned in blocks of three to one of three arms: 1) Control condition (usual care), 2) Brief FOCUS Program, or 3) Extensive FOCUS Program.

Data are collected three times: baseline, prior to the intervention (Time 1); 3 months, shortly after the completion of the intervention (Time 2); and 6 months (Time 3) with a set of established standardized instruments.  The Brief and Extensive Programs were delivered in the home by primarily masters-prepared nurses during the three-month interval between baseline and Time 2 assessments.

The Brief FOCUS Program involved two face-to-face home visits and one follow-up phone call.  The Extensive FOCUS Program was delivered in four face-to-face home visits and two follow-up phone call which doubled the opportunities for the patient-caregiver dyad to discuss their concerns.  FOCUS provides core content in five areas:

1. Family involvement
2. Optimistic attitude
3. Coping effectiveness
4. Uncertainty reduction
5. Symptom management

Significant Group by Time interactions showed there was improvement in dyads’ coping (p<.05), self-efficacy (p<.05), and social quality of life (p<.01), and in caregivers’ emotional quality of life (p<.05). Effects varied by intervention dose. Most effects were found at 3 months only. Risk for distress and other factors accounted for very few moderation effects.

Both brief and extensive programs had positive outcomes for patient-caregiver dyads, but few sustained effects. Patient-caregiver dyads benefit when viewed as the unit of care.