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| Author (s) | Objective and hypothesis listed | Clear eligibility criteria/date study conducted | Settings and sample specified | Interventions clearly described such that replication is possible | Outcome measures specified | Sample size/power analysis | How randomization was accomplished/who randomized | Blinding | Drop out reasons specified | Limitations discussed | Funding source/trial registry | Findings |
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| Antoni et al., [32]. Randomization not indicated in title. | Women in the cognitive behavioral stress management will report reduced anxiety and have reduced serum cortisol and cytokine production. | Female breast cancer patients with stage 1–3 who were within 4 to weeks of surgery. Specific dates for recruiting participants were not specified. | Dade county, Florida. 127 initially, 97 completed the study, 85 assays were completed. This sample came from the larger Antoni [7] study. | Interventions were clearly described including (1) a 10-week group cognitive behavioral stress management or (2) 1 day psychoeducational control group consisting of the same information without group support. | Cancer specific and general anxiety, impact of events scale, serum cortisol, Th1 and Th2 cytokine production. | No power analysis mentioned | Not discussed. | Not mentioned. | Reasons for dropping out not mentioned. Those who dropped out did not differ from completers on outcome or demographic variables. Completer analysis rather than intent-to-treat analyses were used. | Single serum samples of cortisol were used rather than collection across the diurnal cycle. The participants were middle class, white, and well educated. | No discussion of trial registry although it is likely as the study was funded by the National Cancer Institute. | The CB intervention resulted in lower anxiety, lower cortisol, and greater cytokine production. |
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| Antoni et al., [7]. Randomization not indicated in title. | The stress management group will decrease intrusive thought over the short-term and at the end of treatment. | Female breast cancer patients with stage 1–3 who were within 4 to weeks of surgery. Specific dates for recruiting participants were not specified. | Dade county, Florida. 99 women participated | The same interventions as Antoni [32]. They were clearly described. | Thought intrusion and avoidance as measured by the impact of event scale, interviewer rated anxiety, emotional distress measured with the Affects Balance Scale. | No power analysis mentioned | Not discussed | Not mentioned. | Not mentioned. Attrition did not differ by condition. However Hispanic and younger women were more likely to drop out. An intent-to-treat analysis was used. | The sample was middle class, well educated and primarily white. | No discussion of trail registry although it is likely as the study was funded by the National Cancer Institute. | The CB intervention resulted in a greater reduction in cancer-specific thought intrusion, anxiety and emotional distress than did the control. |
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| Miller et al., [25]. Randomization not indicated in title. | The social work (SW) component of a multidisciplinary intervention will improve quality of life of cancer patients. | A vague eligibility criterion of having “advanced cancer and receiving radiation treatment” (p. 109) was used although the authors made reference to the parent study which contained a more detailed methodology section. Recruitment dates were specified. | The setting was not described, although it was likely done in the Mayo Clinic. | An 8-session multidisciplinary intervention (90 minutes) including cognitive-behavioral strategies or standard care extending over 4 weeks. The intervention provided by the social worker was described although other aspects of the multidisciplinary intervention and the standard care interventions were not. | Quality of Life measured at baseline 4, 8, and 27 weeks using the Spitzer QOL Uniscale and Linear Analogue Self-Assessment scales. | 115 of 418 eligible patients were included. A power analysis was discussed. | Patients were externally randomized by the cancer center randomization unit using the Pocock and Simon balance scheme. | No mention was made of blinding of participants or providers. | Numbers of individuals who dropped out and reasons for that were provided. No mention is made of an intent-to-treat type of analysis. | No mention was made whether other cointerventions were monitored, how treatment fidelity was determined. Cultural diversity was lacking. | No mention was made of external funding for the study or registration of the trial. | QOL at week 4 averaged 10 points higher in the intervention group (3% increase from baseline and a 9% decrease in the control group). Significant changes were seen in areas of financial concerns and legal issues (SW component) by week 4. |
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| Pitceathly et al., [26]. The title specified randomization. | A brief intervention, delivered by nonspecialists is superior to usual care in preventing anxiety and depression. | Eligible patients were 18 to 70, newly diagnosed with a first episode of cancer and without anxiety or depressive disorders. Recruitment date years were specified. | Clinics associated with a regional cancer center in Manchester, England. 313 patients participated. | Three immediate sessions of CBT or delayed intervention at 8 weeks from diagnosis or usual care. The first session (90 minutes) was in person followed by two 45-minute telephone sessions. Interventions could be replicated. | Assessment of anxiety and depression at 6 and 12 months (Structured Clinical Interview for DSMIII). Hospital Anxiety and Depression Scale. A 14-item checklist regarding cancer-related concerns. | A power analysis was included. | Independent randomization via computer was used. | Whether patients were blinded is not specified. Data collectors were blinded. | Reasons for dropping out were specified. Analysis was by intent-to-treat. | Years of experience for the nurse and social worker or credentials were not described. Results were not analyzed to see if the type of practitioner mattered. Training and supervision were provided but not by an individual uninvolved in the study. A training manual was developed after the study concluded. At 6 months 27% of patients in the intervention and 16% in usual care could not be assessed. | The study was funded by the United Kingdom (UK) Cancer Research branch. It was not clear if the UK has trial registry. | High-risk patients who received the intervention were less likely to become depressed or anxious than those in the usual care arm at 2, 4, and 6 months. There was no difference between early and delayed intervention. |
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