PT - JOURNAL ARTICLE AU - Nesterova, Darya AU - Zhu, Junjia AU - Kramer, Courtney AU - Vasekar, Monali AU - Truica, Cristina AU - Joshi, Aditya AU - Hayes, Michael AU - Kessler, Jolene AU - Saunders, Erika F H AU - Drabick, Joseph J AU - Joshi, Monika TI - Group-led creative writing and behavioural health in cancer: a randomised clinical trial AID - 10.1136/bmjspcare-2020-002463 DP - 2022 Mar 01 TA - BMJ Supportive & Palliative Care PG - 91--98 VI - 12 IP - 1 4099 - http://spcare.bmj.com/content/12/1/91.short 4100 - http://spcare.bmj.com/content/12/1/91.full SO - BMJ Support Palliat Care2022 Mar 01; 12 AB - Background Cancer diagnosis can adversely affect mental well-being and overall clinical outcome. We evaluated the efficacy of a group-led creative writing workshop (CWW) on mood in patients with cancer prospectively.Methods We conducted a single-institution phase II study. Sixty adult patients with cancer (any type or stage) were randomised 2:1 to CWW (4×CWW sessions, bimonthly over 8 weeks) versus active control (AC) (independent writing at home with the help of a book, four sessions, bimonthly over 8 weeks). The total study duration was 6 months with a follow-up of up to 3 months. Primary objective: changes in overall mood, depression and anxiety symptoms before and after intervention in both arms. Emotional Thermometer Scale (ETS) was used to assess changes in patients’ mood. Additionally, the Patient Health Questionnaire (PHQ)-9 and General Anxiety Disorder Scale (GAD)-7 were used to evaluate depression and anxiety symptoms.Results Of 50 evaluable patients (CWW 34, AC 17), 26 patients in the CWW arm attended at least one class and 19 attended at least four classes. Patients in CWW had significant immediate improvement in the overall ETS (post vs preclass scores; p<0.0001, 95% CI −4.31 to −2.47). Four of the five subscale ETS scores were significantly lower for the CWW arm: distress (p=0.0346, 95% CI −2.6 to −0.1), anxiety (p=0.0366, 95% CI −4.1 to −0.2), depression (p=0.0441, 95% CI −3.9 to −0.1) and anger (p=0.0494, 95% CI −3.3 to 0). No significant differences were seen in the AC arm. No significant differences were observed in the PHQ-9 or the GAD-7 scores.Conclusion CWW had a positive effect on mood based on ETS scores, suggesting a potential therapeutic benefit among patients with cancer.Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. Required data have been submitted to clinical trials.gov. Additional data are available upon request.