Mosher, C.E., Winger, J.G., Hanna, N., Jalal, S.I., Einhorn, L.H., Birdas, T.J., . . . Champion, V.L. (2016). Randomized pilot trial of a telephone symptom management intervention for symptomatic lung cancer patients and their family caregivers. Journal of Pain and Symptom Management, 52, 469–482. 

To test a telephone-based symptom management (TSM) intervention based on social cognitive theory with patients with lung cancer and their caregivers

The control group received education/support. The goal was to test the effect of TSM on the following patient symptoms: anxiety, pain, breathlessness, fatigue, and depressive symptoms. In caregivers, the focus was on anxiety and depressive symptoms. The intervention group dyads received TSM sessions (each was 45 minutes) for four weeks from a licensed social worker who was trained by a psychologist. The intervention involved giving participants instructions on symptom management, problem solving, cognitive restructuring, emotion focused/self-soothing, communication skills, pleasant activity scheduling, and activity pacing. Participants received identical handouts detailing the points discussed and practice assignment and a CD with instructions for relaxation exercises. The teaching was based on various EB cognitive behavioral and emotion-focused strategies. The sessions focused on both the patient and caregiver.

• N = 106 patient-caregiver dyads (intervention group = 51 dyads, control group = 55 dyads)   
• AGE RANGE = TSM group: 20–76 years, control group: 20–80 years
• MEAN AGe = TSM group: 56.33 years (SD = 14.09), control group: 56.75 years (SD = 13.81)
• MALES: 27%, FEMALES: 73% of caregivers
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Caregivers of patients with small and non-small cell lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Dyads were fluent in English, primarily Caucasian, had 13 years of education, and had an average annual household income of $30,000. Sixty-three percent of the caregivers were spouses or partners of the patient. The only difference at baseline between the TSM group and education/support group was caregiver income.

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

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care 

• Randomized, controlled trial with the intervention group (TSM) compared to education/support group

Primary outcomes for the caregivers were:

• Generalized Anxiety Disorder 7-Item Scale (GAD-7) to assess caregiver anxiety symptoms
• The Patient Health Questionnaire-8 (PHQ-8) to assess for depressive symptoms

Secondary outcomes: 

• Kilbourn 8-items to assess self-efficacy in managing emotions
• Social Constraints Scale—5 items to assess perceived social constraints on cancer-related disclosure from the other dyad member

No significant main effects were found for primary outcomes for either patients or caregivers. Small effect size improvement in self-efficacy of caregivers managing their own emotions was observed in the TSM group, while it declined slightly in the education/support group. Also, caregivers in the TSM group reported less perceived social constraints compared to the education/support group. No main effects were noticed in caregivers' self-efficacy in relation to managing patients’ symptoms.

The intervention did not demonstrate a significant effect.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%  
• The intervention included multiple components, so pinpointing cause and effect was difficult.

The effect of a nonpharmacological (psychosocial) intervention on the symptoms of patients with lung cancer and their caregivers is inconclusive. Psychosocial interventions improved caregivers’ self-efficacy in managing their emotions and perception of social constraints.