Merckaert, I., Lewis, F., Delevallez, F., Herman, S., Caillier, M., Delvaux, N., . . . Razavi, D. (2016). Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: A randomized clinical trial comparing the benefits of single-component and multi-component group interventions. Psycho-Oncology. Advance online publication. 

To compare the benefits of two interventions on anxiety in women after initial treatment for breast cancer

Women were randomly assigned to study groups in cohorts of 12 patients. One group received 15 sessions of a single-component support intervention, and the other received a 15-session group intervention combining support with psychoeducational interventions focusing on problem-solving skills, optimizing communications and use of personal and social resources, and self-hypnosis. Interventions were delivered in group settings by clinical psychologists following a structured manual. Sessions were audio and video recorded for use in clinical supervision as needed. Psychologists delivered only one type of intervention to avoid contamination. Study measures were obtained at baseline and after the intervention. All instruments were used with dynamic tasks through completion of the Mental Adjustment to Cancer (MAC) Scale followed by 12 minutes of self-relaxation and through completion of the Fear of Cancer Recurrence Inventory (FCRI) followed by a 12-minute guided hypnosis exercise.

• N = 159 in ITT, 130 completed the study   
• MEAN AGE = 50.6 years (SD = 10.1 years)
• AGE RANGE = 30–82
• FEMALES: 100%
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Women were either receiving radiotherapy or had completed radiotherapy within the past month; 79% had stage 1 or 2 disease.
• OTHER KEY SAMPLE CHARACTERISTICS: Forty-four percent were married or cohabitating, 17% were working full-time, and 66% had a high school or more education.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: France

PHASE OF CARE: Transition phase after active treatment

• Randomized, parallel-group trial

• 10-cm visual analog scale (VAS) for anxiety
• Heart rate
• Relaxation strategies questionnaire
• Hospital Anxiety and Depression Scale (HADS)
• Rating of everyday level of anxiety
• Mental Adjustment to Cancer (MAC) Scale
• Fear of Cancer Recurrence Inventory (FCRI) 

A significant group by time effect was observed in the multicomponent intervention compared to controls for state anxiety after self-relaxation (p = 0.006), for anxiety after guided hypnosis (p = 0.013), and for everyday anxiety level (p = 0.005). No differences were reported between groups in HADs scores. Anxiety and depression scores declined over time in both groups (p < 0.001). The item of psychological distress on the FCRI was reduced in both groups over time, with slightly better improvement in the multicomponent intervention group (p = 0.017).

Both supportive and multicomponent interventions were associated with a decline in anxiety and depression scores over time. The findings suggest that the multicomponent intervention was more effective in enabling women to manage their level of anxiety from triggers that could produce anxiety.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%  
• No report of any differences existed between groups in general demographic and disease variables that could have influenced the results.

Both supportive and multicomponent psychoeducational type interventions were associated with a decline in anxiety and depression over time; however, determining if these changes were associated with the general supportive atmosphere of the group-based intervention is not possible. Anxiety has been shown to decline over time in general as well, without specific intervention. The findings suggest that the combination of self-hypnosis techniques and psychoeducation may enable individuals to manage their anxiety responses more effectively.