Meyers, F.J., Carducci, M., Loscalzo, M.J., Linder, J., Greasby, T., & Beckett, L A. (2011). Effects of a problem-solving intervention (COPE) on quality of life for patients with advanced cancer on clinical trials and their caregivers: Simultaneous care educational intervention (SCEI): linking palliation and clinical trials. Journal of Palliative Medicine, 14(4), 465–473.

 To examine effects of a standardized cognitive-behavioral educational intervention on quality of life (QOL) of patients and their caregivers

Patients designated one caregiver as their coparticipant in the study. Dyads were randomly assigned to intervention or standard care control groups. Those in the intervention arm received a copy of The Home Care Guide for Cancer and participated in three educational sessions with a trained educator. The first session was up to seven days prior to or on the day of entry into a clinical trial. Two additional sessions were done within the next 30 days. Sessions were used to reinforce learning by focusing on patient- or caregiver-identified problems. Usual care was not described. Data were collected at baseline and at 30, 60, 90, 120, and 180 days.

• The sample included 441 patient/caregiver dyads, with 331 dyads in the intervention group. 
• Mean age for patients and caregivers was 61.5 years.
• The male sample was 44% patient and 31% caregiver; the female sample was 55% patient and 68% caregiver.
• Patients had various types of cancer, with the most frequent diagnoses being gastrointestinal, genitourinary, and thoracic cancers.
• All patients had advanced-stage disease and were enrolled in phase 1, 2, or 3 clinical trials.
• Of the caregiver sample, 49% worked full- or part-time, 55% provided four or less hours of care per day or week, 70% were spouses, 65% had college or graduate school education, and 29% had an annual income greater than $80,000.

• Mutlisite  
• Outpatient setting
• Multiple cancer centers in the United States
   

• Active treatment
• End of life and palliative care
   

A randomized controlled trial design was used.

• City of Hope Quality of Life Instrument    
• Social Problem-Solving Inventory
   

Approximately 25% of dyads in both groups withdrew from the study by their own choice. Among patients, there was a five-point decline (100-point scale) in QOL over six months, with no difference between study groups. Among caregivers, those in the control group had QOL scores decline more than those in the intervention group (p = 0.02), according to reported predicted decline from baseline. Caregivers did not show any significant changes in problem-solving skills over time in either study group. The intervention was associated with a slower rate of decline in spiritual aspect of the QOL measure. Caregivers overall showed a decrease in rational problem-solving skills over time, and there were no significant differences between groups, suggesting that the slower decline in  QOL with the intervention were not likely a direct result of improved problem-solving skills.

Findings show some potential benefits in the intervention group, but as pointed out by the authors, differences were not likely as a result of improved problem-solving skills, which was the emphasis of the intervention. The study does not demonstrate convincing effects of this intervention for caregivers.

• The study did not have an appropriate control group or attentional control. 
• The study sample had a relatively high drop-out rate.
• Several aspects of the report were confusing: Inclusion criteria stated that patients receiving chemotherapy or radiation therapy were excluded, yet all were on clinical trials involving some type of treatment intervention. Treatments received were not stated. There was no description of usual care for the control situation.
• The study had no blinding, so there was associated risk of bias.
• The statistical analysis used was a predictive model, apparently to enable analysis in the face of missing data; however, there was no description of how much missing data there was or the percent of attendance at sessions. Analysis attempts to compare actual findings in controls with predicted results in the intervention group are not reasonable. There was no direct statistical comparison between groups or examination of demographic differences between groups, which could be expected to affect results.
• The control group was much smaller than the intervention group, questioning power of analysis across groups.
• Subjects tended to be highly educated and in a higher socioeconomic group; findings may not be widely generalizable.

The study's drop-out rate suggests that this intervention may not be practical or acceptable because most of these were by individual participant choice. The study does not provide convincing evidence of effectiveness of this intervention on quality of life for patients or caregivers.