This trial studies how well a mindfulness-music intervention works in reducing anxiety and stress in adolescents and young adults receiving cancer treatment. A program designed to incorporate music-based meditation practices and music making activities (e.g., guitar, drums) may help to promote relaxation during cancer treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03709225.
PRIMARY OBJECTIVES:
I. Determine the feasibility of adolescents and young adults (AYA) recruitment and adherence to a mindfulness-music intervention during cancer treatment.
Ia. Explore AYAs’ perspectives of acceptability and satisfaction with participation in a mindfulness-music intervention during cancer treatment.
Ib. Examine potential participants’ reasons for declining participation in a mindfulness-music intervention during cancer treatment.
II. Evaluate the impact of a mindfulness-music therapy intervention to reduce anxiety and stress in AYAs receiving cancer treatment.
IIa. Explore the impact of a mindfulness-music therapy intervention to improve fatigue, depression, social/role functioning, pain intensity, pain interference, and sleep-disturbance.
III. Explore demographic and clinical factors that moderate the impact of a mindfulness-music therapy intervention on anxiety and stress severity in AYAs receiving cancer treatment.
IV. Examine the internal consistency reliability and content validity of the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a and Perceived Stress Scale in adolescents and young adults receiving cancer treatment.
OUTLINE:
Patients attend 4 in-person or Zoom music therapy sessions over 45 minutes each over 12 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorRobert J Knoerl