N/A N=73 Randomized Treatment

Adolescents and Young Adults (AYAs) With Advanced Cancer

Adolescent and Young Adult Cancer Patient

Bottom Line

View on ClinicalTrials.gov: NCT05593016 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Treatment Acceptability Questionnaire — 6.02 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) (Behavioral); Education Control Arm (Behavioral)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Acceptability Questionnaire	6.02	—
PRIMARY Session Attendance Percentage	80.20	—
PRIMARY Study Enrollment (Randomized Controlled Trial)	42	—
PRIMARY Pain Severity as Measured by the Brief Pain Inventory (BPI)	2.49; 2.10; 2.28; 2.25	—
PRIMARY Pain Interference as Measured by the Brief Pain Inventory (BPI)	2.53; 2.45; 1.91; 2.07	—
PRIMARY Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	58.64; 54.23; 54.67; 51.24	—
PRIMARY Depressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	56.15; 52.95; 51.35; 52.06	—
PRIMARY Self-Efficacy as Measured by the Managing Chronic Disease Scale	6.75; 7.00; 7.89; 6.90	—
PRIMARY Acceptance and Action	21.19; 17.50; 19.19; 18.43	—
PRIMARY Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)	11.61; 12.5; 12.48; 11.0; 8.87; 9.29	—
PRIMARY Anxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)	58.06; 56.64; 53.81; 53.91	—
PRIMARY Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)	26.42; 27.57; 4.40	—
PRIMARY Values as Measured by the Bulls Eye Values Survey	4.43; 4.15; 4.71; 3.54; 4.62; 3.23	—
PRIMARY Use of Intervention Strategies	2.1	—
PRIMARY Living in Alignment With Values: The Valuing Questionnaire (VQ)	17.05; 20.50; 18.43; 17.93; 13.68; 10.07	—

Summary

This study aims to develop and test the feasibility and acceptability of a psychosocial symptom management intervention designed to meet the unique needs of Adolescents and Young Adults (AYAs) with advanced cancer. The proposed intervention will combine traditional behavioral symptom management strategies commonly use in the palliative care setting with important skills and concepts from Meaning-Centered Psychotherapy and Acceptance and Commitment Therapy. Skills from these approaches may be particularly relevant to AYAs with advanced cancer who experience significant disruption in life goals from cancer and associated symptoms and may have greater difficulties understanding and finding meaning in their lives than older and younger patients. Intervention content, structure, and study procedures will be informed by qualitative data obtained during interviews/focus groups with patient (n=16) and caregiver (n=12) stakeholders as well as review by patient user testers (n=3). It is anticipated that the intervention will include four weekly sessions spaced over 6-8 weeks and be delivered using videoconferencing. Next, AYAs with advanced cancer (N=40) will be randomized to the intervention or education control arms using an allocation ratio of 1.5: 1. The study team will examine the feasibility of study recruitment and retention, acceptability, and changes in variables of interest (i.e., physical and psychological symptoms, symptom interference, self-efficacy for symptom management, experiential avoidance, values) over time for the intervention and control arms. Participants will also provide feedback on study materials, intervention format, and the appropriateness of the intervention to the population and advanced stage of disease.

Eligibility Criteria

Inclusion Criteria

15-29 years old
Diagnosis of advanced (i.e., diagnosis of incurable cancer or distant metastases) or recurrent cancer
Able to speak/read English

Exclusion Criteria

Active serious mental illness (e.g., schizophrenia)
Visual, hearing, or cognitive impairment

Focus Group Caregiver Inclusion Criteria:

18 years old and older
Ability to speak/read English

Focus Group Caregiver Exclusion Criteria:

Visual, hearing or cognitive impairment
Severe mental illness

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05593016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.