Ludwig, G., Krenz, S., Zdrojewski, C., Bot, M., Rousselle, I., Stagno, D., . . . Stiefel, F. (2014). Psychodynamic interventions in cancer care I: Psychometric results of a randomized controlled trial. Psycho-Oncology, 23, 65–74. 

To evaluate the effects of a psychodynamic-oriented intervention in patients with cancer

Patients who consented were randomized to an immediate intervention group or a waitlist controlled group. Patients who did not want to participate were assigned to an observation group, and they agreed to complete study measurements. The intervention involved an immediate phase of four sessions during which the therapist aimed to link the patients’ biographical information with current responses to disease. The authors noted that this intervention was not considered psychotherapy, but it was designed as psychological support. After the initial sessions, subjects were able to participate in 12 additional sessions if they chose to. Study questionnaires were completed by patients in the home at baseline and at four, eight, and 12 months.

• N = 191 (99 in observation group)
• MEAN AGE = 53.2 years (SD = 11.6 years)
• MALES: 34.7%, FEMALES: 65.3%
• KEY DISEASE CHARACTERISTICS: Various cancer types including breast, gastrointestinal, urogenital, respiratory, and hematologic among others
• OTHER KEY SAMPLE CHARACTERISTICS: 32% of patients were receiving psychotropic medications. Baseline anxiety and depression scores were low (below clinically relevant levels). Patients with schizophrenia, major depression, or severe psychiatric illnesses were excluded.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: France

• PHASE OF CARE: Multiple phases of care

Randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
• Symptom checklist
• Toronto Alexithymia Scale (TAS)

Only four patients in the immediate intervention group demonstrated improvements in ​total HADS scores (defined as a 50% improvement in score). Only 31.5% of those initially entered in the study had data for follow-ups, and the number of drop-outs in the waitlist controlled group was higher. There were no significant differences in study outcome measures between groups, and at some time points, control group scores were better. Only 50% of participants were interested in additional sessions of the intervention.

This study did not show any effects for the tested intervention. Multiple study flaws could have contributed to these results.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: There were significant differences in age, use of psychotropic medication, and study measurement scores between the groups at baseline with the intervention group being older with a larger proportion of participants taking medications. Baseline HADS scores were low, suggesting a potential floor effect with study measures. A few patients in the control group requested the intervention and were then added to the intervention group rather than eliminated from the study analysis. There were huge drop-out rates, a lot of missing data, and no ITT analysis. The authors noted that a large number of patients who were approached declined participation. This, along with the large number of drop-outs, suggests that this type of intervention may not be practical or acceptable to patients. It was noted that patients receiving cancer treatment living in rural areas had difficulty participating.

This study did not show any effects of the supportive psychodynamic intervention examined. These results need to be viewed with caution because of the multiple flaws and limitations of the study. This report points to the difficulty of getting sustained patient participation in this type of therapy or research. It is not clear if drop-outs were caused by competing issues such as transportation for sessions, problems encountered during cancer treatment, a lack of patient interest, or sense of benefit. Supportive interventions for patients with cancer need to be practical in their implementation for both providers and patients.