Northouse, L., Kershaw, T., Mood, D., & Schafenacker, A. (2005). Effects of a family intervention on the quality of life of women with recurrent breast cancer and their family caregivers. Psycho-Oncology, 14, 478–491.

To determine if patients with advanced breast cancer and their family caregivers involved in a family-focused intervention report better appraisal, coping, and quality of life and less uncertainty and hopelessness than do similar people involved in standard care only

Dyads (patient/primary family caregiver) were assessed at baseline and stratified according to type of current treatment and number of breast cancer recurrences and then randomized into a usual care group or experimental group (usual care plus FOCUS program). The FOCUS (family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management) program was a family-focused information and support intervention of about 1.5 hours on three occasions scheduled one month apart. Intervention boosters occurred via prearranged follow-up 30-minute telephone conversations with both patients and caregivers led by the same nurse. Dyads completed assessments at baseline, three months after the home visits, and six month following phone conversations.

• The sample included 134 patient/caregiver dyads.   
• Mean caregiver age was 52 years (range = 18–87 years); mean patient age was 54 years.
• The sample was 62% male and 13%+ female (some patient caregivers were daughters, siblings, or friends; later two groups were not identified by gender).
• Patients had a confirmed diagnosis of recurrent breast cancer within the past month/had a disease-free interval at the time. More than half had history of mastectomy, family history of breast cancer, and node involvement with surgery; more than half had experienced their first recurrence of breast cancer; and more than half were receiving chemotherapy or a combination of methods to treat the cancer.
• Of the dyads, 77% were Caucasian and had completed an average education level of 14 years, with median annual family income of $30,000–$50,000.

• Multisite  
• Home setting
• Midwestern United States

Active antitumor treatment phase

A prospective, longitudinal, randomized clinical trial design was used.

• Omega Screening Questionnaire (OSQ) (reliability and validity established earlier)
• Appraisal of Illness Scale
• Appraisal of Caregiving Scale
• Mishel Uncertainty in Illness Scale
• Beck Hopelessness Scale
• Brief COPE
• Functional Assessment of Cancer Therapy (FACT) Scale (version 3, FACT-B, FACT-G)
• Short Form–36 (citations provided affirm all instruments with adequate psychometric properties, current study validated psychometrics)
• Karnofsky  Performance Status Scale
• Patient medical records

Patients who received the FOCUS program reported a significant decrease in negative appraisal of illness from baseline to three months (p < 0.008), while patients who received usual care did not. However, at six months, the FOCUS and usual care groups had similar scores on this dimension. FOCUS group patients significantly decreased their hopelessness score from baseline (p < 0.03), but the usual care group significantly increased their hopelessness score (p < 0.03). At six months postintervention, no significant difference in hopelessness scores existed between groups. FOCUS group caregivers showed a similar significant (p < 0.004) decrease in negative appraisal of illness while the usual care caregivers did not. However, this difference was not sustained at six months. No changes in quality-of-life measures were found over time between usual care and FOCUS group participants (patients and caregivers).

The FOCUS program assisted patients with recurrent breast cancer to report less hopelessness following the initial intervention, and both FOCUS patients and their caregivers reported less negative appraisal of illness; however, intervention effects were not apparent over time. The intervention did not show an effect on caregiver quality-of-life measures.

• The study had baseline sample/group differences of import.
• Risk of bias existed due to no blinding, no appropriate attentional control condition, and sample characteristics.*
• Key sample group differences could have influenced results.*
• Subject withdrawals were ≥ 10%.
• Other limitations/*explanation: There were significant differences between groups in measured hopelessness at baseline.

Study findings suggest that the intervention provided had a short-term effect on improving patient sense of hopelessness. Findings do not support effectiveness of this approach on caregiver quality of life.