Scheier, M.F., Helgeson, V.S., Schulz, R., Colvin, S., Berga, S., Bridges, M.W., . . . Pappert, W.S. (2005). Interventions to enhance physical and psychological functioning among younger women who are ending nonhormonal adjuvant treatment for early-stage breast cancer. Journal of Clinical Oncology, 23, 4298–4311.

This study was designed to evaluate interventions targeted to occur at the point when treatment is ending—a time when distress and concerns are known to increase. It also targets younger women; as some studies report, younger women are at greater risk for psychological distress and face different challenges than older women do.

Women with breast cancer were assigned to a three-arm clinical trial. In the two active arms, the women received either an educational intervention, which provided information about their disease and treatment, or information about nutrition, featuring a low-fat, high-fruit-and-vegetable-eating pattern. Both active treatment arms received four group sessions, meeting once per month for four consecutive months. Sessions were led by professionals, and interactions between participants were kept to a minimum. The control arm was standard medical care. Random assignment assessments occurred at baseline, then 4 months, and 13 months later (corresponding to immediate post-intervention and nine months post-intervention.)

• N = 252
• AGE: 50 years and younger
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS:  Diagnosis of stage 0, I, or II breast cancer with no more than 10 positive lymph nodes
• OTHER KEY SAMPLE CHARACTERISTICS: Within two months of completing nonhormonal adjuvant therapy

• SITE: Multi-site
• LOCATION: Recruited from oncology clinics and medical offices in a single state

• RCT

• Depressive symptoms were assessed using a 10-item version of the CESDS.
• Health-related quality of life was assessed using the SF-36 from the Medical Outcome Studies.
• Mediating measures also were assessed including intrusive thoughts, self-efficacy, cancer concerns, self-concept, and coping.

At the 13th-month assessment, participants in the nutrition arm reported significantly fewer depressive symptoms, and in the education arm, marginally fewer depressive symptoms were reported than in the control arm. The difference between the two active treatment arms was not significant. The mediating factors also were identified as contributing by enhancing self-efficacy expectations, reducing some concerns regarding morbidity and mortality, lessening intrusive thoughts about illness, and buffering self-concept perceptions.

• Compliance with treatment sessions was higher in the nutrition arm than in the education arm.
• The trial focused on early-stage disease; if generalizability exists in patients with advanced disease is not known.
• The sample was composed largely of Caucasian, middle-class women in one state. 
• The sample size was adequate, but little diversity of the sample limits generalizability. 
• The difference between the two treatment arms was not significant.