Clinical trial NCT05593016: Adolescents and Young Adults (AYAs) With Advanced Cancer
Official title: Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent and Young Adult Cancer Patient
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-10-25
Enrollment: 75
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators propose to begin to fill this gap by developing and pilot testing a psychosocial symptom management intervention designed to meet the unique needs of AYAs with advanced cancer. Guided by the team's prior work developing symptom management interventions for older advanced cancer patients and expertise in AYA Oncology, the proposed intervention will combine traditional behavioral symptom management strategies (e.g., activity pacing, relaxation training) commonly used in palliative care with important skills and concepts from Meaning-Centered Psychotherapy (MCP) and Acceptance and Commitment Therapy (ACT). Both MCP and ACT have been associated with decreased distress and symptom burden in oncology patients with advanced cancer. The study team anticipates that the intervention will incorporate questions from MCP to help patients identify valued life areas impacted by symptoms; techniques from ACT will then be used to help patients obtain distance from psychological barriers (e.g., thoughts, emotional experiences) to enacting their values to allow for flexible, value-congruent behaviors. Skills from these approaches may be particularly relevant to AYAs with advanced cancer who experience significant disruption in life goals due to symptoms and may have greater difficulty understanding and finding meaning in their lives.

Aim 1: Intervention Development. Preliminary intervention content has been outlined and will be further informed by interviews with patients (AYAs with advanced cancer, aged 15-29; two groups, n=12), caregivers (one group, n=8), and a combined patient/caregiver group (one group; AYAs: n=4; caregivers: n=4) who will provide information about the symptom (e.g., pain, fatigue, emotional distress) experience of AYAs with advanced cancer, patients' symptom management needs and coping strategies, the unique developmental aspects of being an AYA or caring for an AYA with advanced cancer, and how patient and caregiver needs may interact to impact symptom management. Participant input will help to confirm whether the proposed intervention strategies (i.e., behavioral symptom management, ACT, MCP) may be of benefit for addressing the unique needs of AYAs with advanced cancer. User testing of the developed intervention will be conducted with an additional three AYAs with advanced cancer to further refine the intervention content and format, written study materials, and study procedures.

Aim 2: Pilot Randomized Controlled Trial. AYAs with advanced cancer (N=40) will be randomized to the intervention or an education control arm using an allocation ratio of 1.5:1. Feasibility of study recruitment (N=40 in 12 months) and participant retention (\>80% intervention completion) will be examined along with intervention acceptability. Patterns of change in symptom (i.e., pain, fatigue, distress) severity and interference, self-efficacy for symptom management, and targets of ACT and MCP (e.g., acceptance, experiential avoidance, congruency between values and actions) will be examined.

This pilot trial will allow the study team to refine approaches to identify, recruit, and retain AYA participants and examine patterns of change in key outcome variables for the intervention and control arms. Information obtained will position the investigative team to examine the efficacy of the intervention in a larger randomized controlled trial.

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

Primary outcomes:
measure: Treatment Acceptability Questionnaire
timeFrame: Intervention arm only: post-treatment (6-8 weeks following the baseline assessment)
measure: Session Attendance
timeFrame: Intervention arm only: post-treatment (6-8 weeks following the baseline assessment)
measure: Study Enrollment
timeFrame: All RCT participants: 12 months following the start of study enrollment
measure: Change in Pain Severity and Interference
timeFrame: All RCT participants: baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment
measure: Change in Fatigue
timeFrame: All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
measure: Change in Depressive Symptoms
timeFrame: All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
measure: Change in Self-Efficacy
timeFrame: All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
measure: Change in Acceptance and Action
timeFrame: All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
measure: Change in Values
timeFrame: All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
measure: Change in Anxiety Symptoms
timeFrame: All RCT participants and: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
measure: Intervention Satisfaction: STTS-R
timeFrame: Intervention arm only: post-treatment (6-8 weeks following the baseline assessment)
measure: Use of Intervention Strategies
timeFrame: Intervention arm only: post-treatment (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
measure: Changes in Living in Alignment with Values: The Valuing Questionnaire (VQ)
timeFrame: All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment
Secondary outcomes:
Other outcomes:
measure: Opinion of the Intervention
timeFrame: Intervention arm only: post-treatment (6-8 weeks following the baseline assessment)
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Caroline S Dorfman, PhD
role: PRINCIPAL_INVESTIGATOR
References: