Clinical trial · Interventional
Adolescents and Young Adults (AYAs) With Advanced Cancer
Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adolescent and Young Adult Cancer Patient | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education Control Arm | Behavioral | — | UNRESOLVED |
| Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
- description
- Four, 60-minute sessions will provide training on behavioral symptom management skills, delivered over 6-8 weeks to patients in their homes using videoconferencing.
- interventionNames
- Behavioral: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
- type
- EXPERIMENTAL
- label
- Education Control Arm
- description
- The control arm will receive the NCI booklet, "Taking Time: Support for People with Cancer" and otherwise continue their usual care.
- interventionNames
- Behavioral: Education Control Arm
Primary outcomes (15)
- measure
- Treatment Acceptability Questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 29 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available