Adolescent and Young Adult Cancer PatientNCT05593016
Adolescents and Young Adults (AYAs) With Advanced Cancer
A study testing Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) in people with Adolescent and Young Adult Cancer Patient, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 29 years
- Conditions the study is for
- Adolescent and Young Adult Cancer Patient
- What is being tested?
- Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15-29 years old
- Diagnosis of advanced (i.e., diagnosis of incurable cancer or distant metastases) or recurrent cancer
- Able to speak/read English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention
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.
Read the 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.
- Being tested
- Symptom Management for Improved Physical and Emotional Wellbeing (SMILE), Education Control Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Management for Improved Physical and Emotional Wellbeing (SMILE)Behavioural
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.
Education Control ArmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) | Experimental | Four, 60-minute sessions will provide training on behavioral symptom management skills, delivered over 6-8 weeks to patients in their homes using videoconferencing. Receives: Behavioral: Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) |
| Education Control Arm | Experimental | The control arm will receive the NCI booklet, "Taking Time: Support for People with Cancer" and otherwise continue their usual care. Receives: Behavioral: Education Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Acceptability Questionnaire
The Treatment Acceptability Questionnaire is a 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") and averaged.
Measured: Post-treatment (6-8 weeks following the baseline assessment)
Session Attendance Percentage
Treatment feasibility will be assessed by measuring the session attendance percentage for each participant receiving the intervention.
Measured: Post-treatment (6-8 weeks following the baseline assessment)
Study Enrollment (Randomized Controlled Trial)
Number of participants who enrolled in the randomized controlled trial phase of the study after being found eligible.
Measured: 12 months following the start of study enrollment
Pain Severity as Measured by the Brief Pain Inventory (BPI)
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." Pain severity is calculated as the average of four items assessing participants' worst, least, current, and average (in the last week) pain on a scale from 0 "no pain" to 10 "worst pain."
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Pain Interference as Measured by the Brief Pain Inventory (BPI)
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). Pain interference is computed as the average of seven items, which ask about the interference of pain across different life domains (e.g., general activity, mood, relations with other people) in the past week on a scale from 0 "Does not interfere" to 10 "Completely interferes." Higher scores indicate higher levels of pain interference.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Fatigue will be assessed using the PROMIS Computer Adaptive Test for Fatigue. Questions ask participants to rate their fatigue during the past 7 days. The T-score ranges from 0 to 100, where higher T-scores indicate greater fatigue. Scores are converted to standardized t-scores with a mean of 50 and standard deviation of 10. T-scores of 55 to <60 indicate mild levels of fatigue, ≥60 to <70 indicates moderate levels of fatigue, and ≥70 indicate severe levels of fatigue.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Depressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
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. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of depression. T-scores of 55 to <60 indicate mild levels of depression, ≥60 to <70 indicates moderate levels of depression, and ≥70 indicate severe levels of depression.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Self-Efficacy as Measured by the Managing Chronic Disease Scale
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." The score for the scale is the mean of the six items, with higher number indicating higher self-efficacy.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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 total score ranges from 7 to 49, where a higher score indicates greater psychological inflexibility.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)
The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire. Responses for each item are on a scale from 0 = "not at all" to 4 = "very much." Three subscale scores (Meaning, Peace, Faith) are calculated by summing specific items. Each subscale has 4 items, with total scores ranging from 0 to 16, with higher scores indicating greater well-being for each subscale (Meaning, Peace, or Faith). A total score is calculated as the sum of the three subscores, with total scores ranging from 0 to 48. Higher scores represent greater spiritual wellbeing.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Anxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The PROMIS Computer Adaptive Test for Anxiety will be used to assess anxiety symptoms in the last week. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of anxiety. T-scores of 55 to <60 indicate mild levels of anxiety, ≥60 to <70 indicates moderate levels of anxiety, and ≥70 indicate severe levels of anxiety.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)
The SSTS-R is a 13-item measure. The first 12-items ask participants to rate their satisfaction with the therapy received (6-items) or the therapist delivering the intervention (6-items) on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly disagree." Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater satisfaction. The 13th item (Global Improvement) asks, "How much did the intervention help with your symptoms?" with 5 answer choices ranging from 1 "made things a lot worse" to 5 "made things a lot better," where higher scores indicate a better outcome.
Measured: Post-treatment (6-8 weeks following the baseline assessment)
Values as Measured by the Bulls Eye Values Survey
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). Then, participants are asked to think of their values in each domain as "bull's eye" (the middle of the dart board). A 1 is equal to a hit in the bull's eye, which means that they are living completely in keeping with their value for that area of living. An 8 is equal to far from the bull's eye, which means that their life is way off the mark in terms of how they are living their life. 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".
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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 4 "6 or more days per week" is used.
Measured: Post-treatment (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment; post-treatment (6-8 weeks following the baseline assessment) reported
Living in Alignment With Values: The Valuing Questionnaire (VQ)
The Valuing Questionnaire is a 10-item self-report questionnaire with a scale 0 = "not true at all" to 6 "completely true." Two subscale scores are calculated, Progress and Obstruction, which typically have a negative correlation. Higher scores on the Progress subscale represent a closer alignment between one's internal values and one's actions. Higher scores on the Obstruction subscale represent more interference with living consistently with one's values. The range for both subscales is 0 to 30.
Measured: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start17 Jan 2023
- Primary completion30 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent and Young Adult Cancer PatientStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Caroline S Dorfman, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593016
- Sponsor's protocol ID
- Pro00110574
- Other IDs
- R21CA263727-01A1
- Status last verified
- Oct 2025
- First submitted
- 14 Oct 2022
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Symptom Management for Adolescents and Young Adults With Advanced Cancer: Development and Pilot Testing of a Novel Intervention
- ClinicalTrials.gov ID
- NCT05593016
- Acronym / sponsor ID
- Pro00110574
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Posted 3 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) | Experimental | Behavioral: 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. |
| Education Control Arm | Experimental | Behavioral: Education Control ArmThe control arm will receive the NCI booklet, "Taking Time: Support for People with Cancer" and otherwise continue their usual care. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 15-29 years old
- Diagnosis of advanced (i.e., diagnosis of incurable cancer or distant metastases) or recurrent cancer
- Able to speak/read English
Key exclusion criteria (8 listed)
- Active serious mental illness (e.g., schizophrenia)
- Visual, hearing, or cognitive impairment
- 18 years old and older
- Ability to speak/read English
- Visual, hearing or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) |
| Education Control ArmThe 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. | Behavioural | Education Control Arm |
Primary outcome
Treatment Acceptability Questionnaire
Time frame: Post-treatment (6-8 weeks following the baseline assessment)
The Treatment Acceptability Questionnaire is a 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") and averaged.
Session Attendance Percentage
Time frame: Post-treatment (6-8 weeks following the baseline assessment)
Treatment feasibility will be assessed by measuring the session attendance percentage for each participant receiving the intervention.
Study Enrollment (Randomized Controlled Trial)
Time frame: 12 months following the start of study enrollment
Number of participants who enrolled in the randomized controlled trial phase of the study after being found eligible.
Pain Severity as Measured by the Brief Pain Inventory (BPI)
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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." Pain severity is calculated as the average of four items assessing participants' worst, least, current, and average (in the last week) pain on a scale from 0 "no pain" to 10 "worst pain."
Pain Interference as Measured by the Brief Pain Inventory (BPI)
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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). Pain interference is computed as the average of seven items, which ask about the interference of pain across different life domains (e.g., general activity, mood, relations with other people) in the past week on a scale from 0 "Does not interfere" to 10 "Completely interferes." Higher scores indicate higher levels of pain interference.
Fatigue as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
Fatigue will be assessed using the PROMIS Computer Adaptive Test for Fatigue. Questions ask participants to rate their fatigue during the past 7 days. The T-score ranges from 0 to 100, where higher T-scores indicate greater fatigue. Scores are converted to standardized t-scores with a mean of 50 and standard deviation of 10. T-scores of 55 to <60 indicate mild levels of fatigue, ≥60 to <70 indicates moderate levels of fatigue, and ≥70 indicate severe levels of fatigue.
Depressive Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of depression. T-scores of 55 to <60 indicate mild levels of depression, ≥60 to <70 indicates moderate levels of depression, and ≥70 indicate severe levels of depression.
Self-Efficacy as Measured by the Managing Chronic Disease Scale
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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." The score for the scale is the mean of the six items, with higher number indicating higher self-efficacy.
Acceptance and Action
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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 total score ranges from 7 to 49, where a higher score indicates greater psychological inflexibility.
Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire. Responses for each item are on a scale from 0 = "not at all" to 4 = "very much." Three subscale scores (Meaning, Peace, Faith) are calculated by summing specific items. Each subscale has 4 items, with total scores ranging from 0 to 16, with higher scores indicating greater well-being for each subscale (Meaning, Peace, or Faith). A total score is calculated as the sum of the three subscores, with total scores ranging from 0 to 48. Higher scores represent greater spiritual wellbeing.
Anxiety Symptoms as Measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
The PROMIS Computer Adaptive Test for Anxiety will be used to assess anxiety symptoms in the last week. Scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher T-scores indicate higher levels of anxiety. T-scores of 55 to <60 indicate mild levels of anxiety, ≥60 to <70 indicates moderate levels of anxiety, and ≥70 indicate severe levels of anxiety.
Intervention Satisfaction as Measured by the Satisfaction With Therapy and Therapist-Revised (SSTS-R)
Time frame: Post-treatment (6-8 weeks following the baseline assessment)
The SSTS-R is a 13-item measure. The first 12-items ask participants to rate their satisfaction with the therapy received (6-items) or the therapist delivering the intervention (6-items) on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly disagree." Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater satisfaction. The 13th item (Global Improvement) asks, "How much did the intervention help with your symptoms?" with 5 answer choices ranging from 1 "made things a lot worse" to 5 "made things a lot better," where higher scores indicate a better outcome.
Values as Measured by the Bulls Eye Values Survey
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
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). Then, participants are asked to think of their values in each domain as "bull's eye" (the middle of the dart board). A 1 is equal to a hit in the bull's eye, which means that they are living completely in keeping with their value for that area of living. An 8 is equal to far from the bull's eye, which means that their life is way off the mark in terms of how they are living their life. 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".
Use of Intervention Strategies
Time frame: Post-treatment (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/ follow-up assessment; post-treatment (6-8 weeks following the baseline assessment) reported
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 4 "6 or more days per week" is used.
Living in Alignment With Values: The Valuing Questionnaire (VQ)
Time frame: Baseline, post-treatment/follow-up (6-8 weeks following the baseline assessment), 4 weeks following the post-treatment/follow-up assessment; baseline and post-treatment (6-8 weeks following the baseline assessment) reported
The Valuing Questionnaire is a 10-item self-report questionnaire with a scale 0 = "not true at all" to 6 "completely true." Two subscale scores are calculated, Progress and Obstruction, which typically have a negative correlation. Higher scores on the Progress subscale represent a closer alignment between one's internal values and one's actions. Higher scores on the Obstruction subscale represent more interference with living consistently with one's values. The range for both subscales is 0 to 30.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline S Dorfman, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom Management for Improved Physical and Emotional Wellbeing (SMILE) in people with Adolescent and Young Adult Cancer Patient, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Acceptability Questionnaire (time frame: Post-treatment (6-8 weeks following the baseline assessment)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.