Porter, L.S., Keefe, F.J., Garst, J., Baucom, D.H., McBride, C.M., McKee, D.C., . . . Scipio, C. (2011). Caregiver-assisted coping skills training for lung cancer: Results of a randomized clinical trial. Journal of Pain and Symptom Management, 41, 1–13. 

To assess the efficacy of two variant cognitive skills training (CST) interventions for the caregivers of patients with lung cancer to improve caregiver distress, self-efficacy, and strain

Following a baseline data collection period, participants (patient-caregiver dyads) were randomly assigned to either CST or a cancer education and support group. Trained research assistants blinded to participant treatment groups collected patient and caregiver assessments via telephone calls immediately after each treatment session and at four months post-study. Fourteen 45-minute, telephone-based sessions with individual dyads using speaker phones occurred over an eight-month period. All study patients continued regular healthcare visits informed by including educational information. Trained, registered nurses adhering to detailed and audiotaped treatment outlines received weekly supervision and evaluation from study psychologists. Dyads in the CST group received information about ways to manage disease symptoms, homework assignments, and a CD focused on stress management. The education and support dyad group received lung cancer disease and treatment information, including hospice and palliative care, in a supportive environment without focus on coping skills training.

• N = 233 dyads  
• MEAN CAREGIVER AGE = 59.3 years
• CAREGIVER MALES: 31%, CAREGIVER FEMALES: 69%
• KEY DISEASE CHARACTERISTICS: Caregivers of patients with a diagnosis of early stage lung cancer (non-small cell lung cancer stages 1–3 or limited stage small-cell lung cancer); median of 207.5 days since patient diagnosis; 81% with history of cancer surgery; more than half with stage 1 non-small cell lung cancer
• OTHER KEY CAREGIVER SAMPLE CHARACTERISTICS: 82% Caucasian; 44% college educated; 64% spousal caregivers living with patient

• SITE: Multi-site    
• SETTING TYPE: Multiple settings  
• LOCATION: Home telephone intervention, North Carolina

• PHASE OF CARE: Multiple phases of care

Randomized, controlled trial with blinding of intervention

• Profile of Mood States–B (POMS-B) measuring six aspects of mood (high Cronbach’s alpha)
• Caregiver Strain Index (CSI) measuring caregiver common stressors (high internal consistency and construct validity)
• Modified Caregiver Self-Efficacy in Symptom Management (CSESM) measuring caregiver perceived ability to help patient manage disease symptoms (high Cronbach’s alpha)

No significant demographic or medical variable differences existed between dyads in the CST and education and support groups. Caregiver outcome measures indicated significant main effects over time for the POMS-B anxiety subscale (p = 0.02) and self-efficacy (p = 0.01). Both intervention groups showed decreases in caregiver anxiety and increases in their self-efficacy to manage patient symptoms although no significant time to intervention occurred with hierarchical linear modeling. An exploratory moderator analysis showed the education and support intervention to most benefit the caregivers of patients with stage 1 cancer. The CST intervention most benefited the caregivers of patients with stage 2 or 3 lung cancer.

CST and education and support intervention improved patient and caregiver anxiety and efficacy although the lack of a nontreatment group prevented specific conclusions about either intervention approach. Influences of time and attention may have affected dyadic outcomes. More research on important intervention aspects and their operation for improved lung cancer clinical practice is needed.

• Risk of bias (no control group)
• Findings not generalizable
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: The distinction between the education provided to the CST group and the education and support group was not clear.

Identifying effective caregiver support interventions to aid in the care of patients with lung cancer remains a priority because of high levels of patient and caregiver distress and low self-efficacy. Additional studies need to include diverse participants, structured protocols for data collection and evaluation, a standard care (control) group, and innovative recruitment and retention methods for caregivers to strengthen the clinical practice evidence for this group of caregivers.