Björneklett, H. G., Lindemalm, C., Ojutkangas, M. L., Berglund, A., Letocha, H., Strang, P., & Bergkvist, L. (2012). A randomized controlled trial of a support group intervention on the quality of life and fatigue in women after primary treatment for early breast cancer. Supportive Care in Cancer, 20, 3325–3334.

To evaluate the effects of a psychosocial support intervention on health-related quality of life (QOL) and fatigue.

Participants were randomized to an intervention or usual care control group. The intervention consisted of education sessions mixed with exercise, relaxation training, massage, qigong, visualization, and social activities, such as concerts and museum and restaurant visits. As reported in a previous pilot study, participants were residents at a spa-type facility during the intervention. The intervention was provided by an interdisciplinary group comprising physicians, psychologists, an art therapist, a massage therapist, a dietician, social workers, and a trained qigong provider for seven days. Follow-up was performed at two, six, and 12 months. Participants in the usual care control were only provided follow-up data collection.

• In total, 360 participants (100% female) were included.             
• Mean age was 58 years (range 30–84).
• All participants had breast cancer. Most had undergone breast-conserving surgery and had received or were receiving radiation therapy.
• Of the participants, 53% were married.

• Single site  
• Inpatient   
• Sweden

• Participants were undergoing the transition phase after active treatment.
• The study has clinical applicability for elderly care.

The study was a randomized, controlled trial.

• Swedish version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), including the 23-item breast cancer module
• Fatigue Questionnaire, Swedish version

Fatigue scores were similar in both groups and declined over time up to 12 months in both groups. There were no differences in fatigue levels over time between the groups. There were no significant effects of the intervention on QOL measures.

The multimodal intervention demonstrated no significant effect on QOL or fatigue.

• The study had risks of bias due to no blinding, no appropriate attentional control condition, and the sample characteristics.
• The findings were not generalizable.
• The intervention was expensive, impractical, and required training.
• Participants tended to self-select for involvement. 
• This type of week-long stay and set of interventions can be expected to be expensive.

The specific approach providing a multifaceted, psychoeducational type of intervention was not shown to affect fatigue or QOL in women with breast cancer. The most effective content, duration, and frequency of psychosocial and multimodal support interventions were not clear.