Serfaty, M., Wilkinson, S., Freeman, C., Mannix, K., & King, M. (2012). The ToT study: Helping with Touch or Talk (ToT): A pilot randomised controlled trial to examine the clinical effectiveness of aromatherapy massage versus cognitive behaviour therapy for emotional distress in patients in cancer/palliative care. Psycho-Oncology, 21, 563–569.

To pilot a randomized trial examining the effectiveness of cognitive behavioral therapy (CBT) and aromatherapy massage (AM) in reducing emotional distress in patients with cancer and to compare the differences in effectiveness between the CBT and AM groups

Participants were randomized to one of two treatment groups: CBT or AM. The study did not explain how the CBT intervention was actually implemented, except to note that trained and accredited therapists delivered the therapy. The study listed the topics covered in the CBT sessions but did not describe the procedures, group-session format, etc. AM was described as standard massage with 20 essential oils, delivered by a trained aromatherapist, in a quiet room with minimal talking. Each group received one of these interventions along with “treatment as usual” (standard care). Both groups were offered, after study entry, up to eight one-hour sessions delivered over 10 weeks. Time interval between treatments was not delineated.

• The study reported on a sample of 36 patients (39 enrolled; 3 dropped out before postintervention assessment).
• Mean patient age was 52.5 years.
• The sample was 79% female (n = 31) and 21% male (n = 8).
• The sample was composed mostly of patients with breast and colorectal cancer but also included patients with lung or prostate cancer, lymphoma, and myeloma.
• The stage of disease and other characteristics, such as type of treatment, was unspecified. Also unspecified was whether participants were receiving pharmacologic treatment for emotional distress (anxiety or depression) or some other psychological support. Study participants were screened, by means of the Hospital Anxiety and Depression Scale (HADS), for anxiety and depression. The initial cut score was 8. (An initial cut score of 8–10 is considered borderline for anxiety or depression.) Four months after study initiation, the cut score was increased to 11. (A cut score of 11 or higher is considered clinically significant.) The demographics of the CBT and AM groups were similar except in regard to gender: The CBT group contained only one male; seven males were in the AM group. In both groups, the total sample size was too small to allow researchers to detect significance differences.

• Single site
• Outpatient setting
• An urban teaching hospital, recruited from outpatient oncology clinics, in London, England

Patients were undergoing multiple phases of care.

The study, a pilot, was a randomized, single-blind, prospective, repeated-measure clinical trial with no control group. Measures were collected at baseline and at three and six months postintervention.

• Hospital Anxiety and Depression Scale (HADS): For screening and participant eligibility
• At baseline: Treatment preferences and beliefs about effectiveness and satisfaction with either CBT or AM
• Profile of Mood States Short Form (POMS-SF): Total mood disturbance score (TMS), summed from six subscales
• Psychological Outcomes Profiles (PSYCHLOPS): Six-point Likert scale to assess distress, duration, and impact of two patient-derived problem areas
• EuroQol: A health-related quality-of-life measure
• Client event recall: Asking patients about their experience with the therapy
• Consultation and Relational Empathy (CARE) measure: To quantify each patient’s perception of relational empathy with the therapist

The study was drastically underpowered, with too small a sample to allow researchers to draw meaningful conclusions. The study produced no statistically significant findings.

• With low recruitment (8%), a protracted period (two years, but still called a pilot?), and an underpowered design that lacked a strong conceptual grounding and rationale, this study produced no meaningful conclusions and suggested no direct application to practice.
• Both therapies, AM and CBT, were well received and posed no risk of harm.
• To treat the \"whole patient,\" nonpharmacologic interventions should be offered, when possible, to patients with cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no control group and as the result of sample characteristics.
• Findings are not generalizable.
• The study used nonrandom (convenience) sampling with a low accrual rate.
• Screening criteria changed four months into the trial, but data do not differentiate participants (defined only as patients with HADS greater than 8).
• Rationale for sampling time points is unclear (e.g., why should researchers expect an effect three to six months after AM?).
• Time between last treatment (AM or CBT) and three-month sampling is not noted, so relating outcomes to intervention is difficult.
• Participants were allowed to select the  number of therapy sessions to attend, which is certainly a weakness.
• Whether CBT was delivered in a group format cannot be ascertained.

AM may be beneficial as a treatment for short-term anxiety. This poorly designed and controlled pilot study offers no other immediate nursing implication.