Greer, J.A., Traeger, L., Bemis, H., Solis, J., Hendriksen, E.S., Park, E.R., . . . Safren, S.A. (2012). A pilot randomized controlled trial of brief cognitive-behavioral therapy for anxiety in patients with terminal cancer. Oncologist, 17, 1337–1345.

DOI Link

Study Purpose

To examine the use of cognitive-behavioral therapy (CBT) as an intervention to reduce anxiety in patients diagnosed with terminal cancer

Intervention Characteristics/Basic Study Process

CBT was adapted by the development of training modules targeting skills for relaxation, coping, and activity pacing. Eligibility included patients who were 18 years or older with an incurable solid tumor, four weeks post-diagnosis, and found to have anxiety as evidenced by a Hamilton Anxiety Rating Scale (HAM-A) score of 14 or higher. They were screened via telephone and met with a licensed clinical psychologist or postdoctoral psychology fellow for a baseline assessment and self-report questionnaires. If criteria was met, they were randomized to either individualized CBT or a wait-list control group. The intervention group met with a therapist for six to seven (optional) weekly sessions of CBT tailored to patient concerns. A post-treatment or eight-week assessment with a blinded independent evaluator was used, and the nonintervention patients were then able to cross over to receive CBT if desired.

Sample Characteristics

  • The study reported on a sample of 40 patients.
  • Mean patient age was 55.90 years, with a range of 31–81 years.
  • The sample was 70% female and 30% male.
  • Patients were diagnosed with lung (30%), pancreatic (17%), colorectal (15%), other (38%) cancers.
  • Patients had solid tumors only and were mostly white (95%).
  • Demographic characteristics did not differ between the two groups.

Setting

  • Single site
  • Outpatient setting
  • Massachusetts General Hospital Cancer Center

Phase of Care and Clinical Applications

  • Patients were undergoing active antitumor treatment.
  • The study has clinical applicability for elder care and palliative care.

Study Design

A pilot feasibility and randomized controlled trial design was used.

Measurement Instruments/Methods

  • For the clinician-administered assessment, the primary outcome measure was total score on the HAM-A
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Impact of Event Scale (IES)
  • Functional Assessment of Cancer Therapy–General (FACT-G)

Results

Forty patients with terminal cancers were randomized to receive CBT (n = 20) or to a wait-list control group (n = 20), with 70% completing the post-treatment assessments. In the treatment group, 80% completed at least five of the six required sessions. Analysis revealed that those receiving CBT had greater improvements in HAM-A scores compared to the control group, with an adjusted mean difference of -5.41 (95% confidence interval: -10.78 to -0.04) and a large effect size for intervention (Cohen’s d = 0.80).

Conclusions

It was found that the majority of patients in the intervention sample were able to complete the requirements of the trial, and beneficial effects were observed in reducing anxiety and improving quality of life over time, but no significant differences in depression between the two groups.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • Study findings are not generalizable.
  • The intervention was expensive, impractical, or had training needs.
  • The use of routine screening procedures would be beneficial.
  • The sample lacked racial and ethnic diversity, limiting generalizability to minority patients.

Nursing Implications

Patients who are newly diagnosed with incurable cancer can be at high risk for anxiety. The early identification of these patients and assisting them in accessing care using CBT can lead to significant improvements in anxiety and quality of care.