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NCT05593016Completed

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 · Last updated 3 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
75 (actual)
First submitted
14 Oct 2022
Start date
17 Jan 2023
Primary completion date
30 Jul 2024
Lead sponsor
Duke University
NCT number
NCT05593016

What you commit to

  • Study type: Interventional
  • Participants enrolled: 75
  • From 17 Jan 2023 to the primary completion date, 30 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active serious mental illness (e.g., schizophrenia)
  • Visual, hearing, or cognitive impairment
    • Focus Group Caregiver Inclusion Criteria:
  • Visual, hearing or cognitive impairment
  • Severe mental illness

Age

  • 18 years old and older

Other

  • Ability to speak/read English
    • Focus Group Caregiver Exclusion Criteria:

Who the study is looking for

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

Age in the registry: 15 years to 29 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke Cancer Institute
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.