Study Protocol for a Randomized Controlled Trial of the Efficacy of Expressive Art Therapy on Quality of Life amongst Children with Acute Lymphoblastic Leukemia

Background: Childhood cancer, specifically acute lymphoblastic leukemia (ALL), poses substantial psychological, physical, and emotional challenges, affecting the quality of life (QoL). Expressive art therapies integrate movement, art, and music and offer developmentally appropriate, nonverbal interventions that enhance resilience, coping, and emotional well-being. Novelty: Routine psychological interventions are not suitable for children and adolescents who may have difficulty formulating or expressing their experiences and feelings, particularly in our cultural context. In such clinical situations, creative therapies, such as expressive art therapies may be used. Objectives: The primary objective will be to evaluate the change in QoL with some secondary objectives to evaluate from baseline after 6 and 12 weeks of treatment with treatment as usual (TAU) plus expressive art therapy versus TAU amongst children with ALL. Methods: The proposed study is a prospective, randomized parallel design trial. Following the inclusion and exclusion criteria, children will be recruited and randomized into 2 treatment groups. One group will receive TAU plus expressive art therapy and another group will receive TAU for 12 weeks in a clinic-based setting. Clinical status and functioning will be checked by using Cancer Institute Pediatric Oncology Quality of Life Questionnaire-31 (CI‑Ped Onc QLQ 31) scale score, State-Trait Anxiety Inventory for Children (STAI-C) anxiety score, Rosenberg Self-Esteem Scale score, and perceived stress score at baseline, 6 and 12 weeks. Expected Outcomes: Expressive art therapy may demonstrate greater reduction in anxiety levels, perceived stress, and improvement in self-esteem and QoL over the 12 week period in children with ALL. It may be used as add-on therapy in children with hematological cancer in Indian context.