Adolescents and Young Adults (AYAs) With Advanced Cancer

Study Overview
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Brief Summary
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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 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
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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.

Official Title
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Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention

Conditions
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Adolescent and Young Adult Cancer Patient

Intervention / Treatment
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* Behavioral: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
* Behavioral: Education Control Arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)<br>Four, 60-minute sessions will provide training on behavioral symptom management skills, delivered over 6-8 weeks to patients in their homes using videoconferencing. | Behavioral: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)<br>* Participating in the SMILE arm of the study will consist of four, 60-minute sessions delivered over 6-8 weeks to patients in their homes using videoconferencing. Intervention will provide training in behavioral symptom management skills (e.g.,relaxation training, activity-rest cycling) and include skills from ACT and MCP targeting avoidance of uncomfortable experiences (e.g., thoughts, emotions) and promoting engagement in value-directed activity.<br>|
| Experimental: Education Control Arm<br>The control arm will receive the NCI booklet, Taking Time: Support for People with Cancer and otherwise continue their usual care. | Behavioral: Education Control Arm<br>* The control arm will receive the NCI booklet, Taking Time: Support for People with Cancer, which provides basic strategies for symptom (e.g., pain, fatigue, stress) management, coping with negative emotions, and communication and will continue their usual medical care of advanced cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Acceptability Questionnaire | Six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 very unacceptable to 7 very acceptable). | Intervention arm only: post-treatment (6-8 weeks following the baseline assessment) | 
| Session Attendance | Treatment feasibility will be assessed by measuring the session attendance rate for each participant receiving the intervention. | Intervention arm only: post-treatment (6-8 weeks following the baseline assessment) | 
| Study Enrollment | Rate of study enrollment measured by recruiting 40 participants over 12 months. | All RCT participants: 12 months following the start of study enrollment | 
| Change in Pain Severity and Interference | The Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Participants rate their pain on a scale from 0 no pain to 10 pain as bad as you can imagine. | All RCT participants: baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment | 
| Change in Fatigue | Fatigue will be assessed using the PROMIS Computer Adaptive Test for Fatigue. Questions ask participants to rate their fatigue during the past 7 days. Higher scores indicate greater fatigue. | All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment | 
| Change in Depressive Symptoms | Depressive Symptoms will be assessed using the PROMIS Computer Adaptive Test for Depression Questions ask participants to respond to questions during the past 7 days. The higher the total score, the more severe the depressive symptoms are. | All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment | 
| Change in Self-Efficacy | The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 not at all confident to 10 totally confident. | All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment | 
| Change in Acceptance and Action | 7-Item: The Acceptance and Action Questionnaire-II assesses acceptance, experiential avoidance and psychological flexibility. Question scale ranges from 1, never true, to 7, always true. The higher the total score is, the less psychological flexibility. Lower scores indicate more psychological flexibility. | All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment | 
| Change in Values | The Bulls Eye Values Survey assists participants with clarifying their values and will be used to examine participants' personal values, values attainment, and persistence towards values in the face of barriers. Part 1 asks the person to record values for 4 domains (work/education, relationships, personal growth/health, and leisure). Part 2 asks the person to identify obstacles to those values and rate from 1, doesn't prevent me at all, to 7, prevents me completely. Part 3 asks the person to identify a value based action to take for each of the 4 domains. | All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment | 
| Change in Anxiety Symptoms | PROMIS Computer Adaptive Test for Anxiety will be used to assess anxiety symptoms in the last week. The higher the total score, the more anxiety symptoms present. | 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 | 
| Intervention Satisfaction: STTS-R | Intervention satisfaction will be assessed using the SSTS-R, a 13-item measure with the first 12-items on a five-point scale ranging from 1 strongly disagree to 5 strongly disagree. The 13th item asks, How much did the intervention help with your sypmtoms? with 5 answer choices ranging from made things a lot better to made things a lot worse. | Intervention arm only: post-treatment (6-8 weeks following the baseline assessment) | 
| Use of Intervention Strategies | Participants' use of intervention strategies will be assessed using a measure developed specific to components of the proposed intervention. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 not at all to 5 2 or more times a day will be used. | Intervention arm only: post-treatment (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment | 
| Changes in Living in Alignment with Values: The Valuing Questionnaire (VQ) | The VQ is a 10-item self-report questionnaire with a scale 0 = not true at all to 6 completely true. | All RCT participants: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment |