Trial Outcomes & Findings for Adolescents and Young Adults (AYAs) With Advanced Cancer (NCT NCT05593016)

Two consented participants were lost to follow-up prior to completing the baseline assessment and were not randomized.

Adolescents and Young Adults (AYAs) With Advanced Cancer

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.

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

Number of participants who enrolled in the randomized controlled trial phase of the study after being found eligible.

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."

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 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 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.

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.

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.

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.

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.

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.

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".

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.

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.