Adolescents and Young Adults (AYAs) With Advanced Cancer

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05593016
Collaborator
National Cancer Institute (NCI) (NIH)
40
1
2
17.4
2.3

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
  • Behavioral: Education Control Arm
N/A

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 focus groups with patients (AYAs with advanced cancer, aged 15-29; two groups, n=6/group), 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention
Actual Study Start Date :
Jan 17, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)

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)
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.

Experimental: Education Control Arm

The control arm will receive the NCI booklet, "Coping with Advanced Cancer" and otherwise continue their usual care.

Behavioral: Education Control Arm
The control arm will receive the NCI booklet, "Coping with Advanced Cancer," which provides basic strategies for symptom (e.g., pain, fatigue) management, coping with negative emotions, and communication and will continue their usual medical care of advanced cancer.

Outcome Measures

Primary Outcome Measures

  1. Treatment Acceptability Questionnaire [Intervention arm only and user testers: post-treatment (6-8 weeks following the baseline assessment)]

    Six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective.

  2. Session Attendance [Intervention arm only and user testers: post-treatment (6-8 weeks following the baseline assessment)]

    Treatment feasibility will be assessed by measuring the session attendance rate for each participant receiving the intervention.

  3. Study Enrollment [All RCT participants: 12 months following the start of study enrollment]

    Rate of study enrollment measured by recruiting 40 participants over 12 months.

  4. Change in Pain Severity and Interference [All RCT participants and user testers: baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment]

    Pain severity and interference will be measured by the Brief Pain Inventory 9-Item Scale which rates pain from 0, "no pain", to 10, "pain as bad as you can imagine".

  5. Change in Fatigue [All RCT participants and user testers: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment]

    Fatigue will be assessed using the PROMIS Fatigue Scale, a 13-item self-report measure of fatigue. Questions ask during the past 7 days to rate fatigue questions from 1, not at all fatigued, to 5 very much fatigued.

  6. Change in Depressive Symptoms [All RCT participants and user testers: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment]

    Depressive Symptoms will be assessed using the PROMIS Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Questions ask during the past 7 days how true is the statement from 1, never, 2 rarely, 3 sometimes, 4 often, and 5 always. The higher the total score, the more severe the depressive symptoms are.

  7. Change in Symptom Interference [All RCT participants and user testers: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment]

    Illness Intrusiveness Rating Scale (IIRS). IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation).

  8. Change in Self-Efficacy [All RCT participants and user testers: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment]

    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."

  9. Change in Acceptance and Action [All RCT participants and user testers: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment]

    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.

  10. Change in Values [All RCT participants and user testers: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment]

    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.

  11. Change in Anxiety Symptoms [All RCT participants and user testers: baseline, post-treatment/ follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment]

    PROMIS Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Question scale ranges from 1, never, 2, rarely, 3, often, 4, sometimes, 5, always. The higher the total score, the more anxiety symptoms present.

Other Outcome Measures

  1. Opinion of the Intervention [Intervention arm only and user testers: post-treatment (6-8 weeks following the baseline assessment)]

    Open-ended feedback on study materials, the intervention format, and the appropriateness of the intervention for the population.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 15-29 years old

  • Diagnosis of advanced cancer (i.e., diagnosis of incurable cancer or distant metastases

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Cancer Institute Durham North Carolina United States 27701

Sponsors and Collaborators

  • Duke University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Caroline S Dorfman, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05593016
Other Study ID Numbers:
  • Pro00110574
First Posted:
Oct 25, 2022
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 26, 2023