Adults 18 to 39, any sex, with Cancer or Young Adult. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R)Primary· Following completion of the intervention, up to 12 months
Intervention satisfaction will be assessed using the Satisfaction witth Therapy and Therapist Scale-Revised, a 13-item measure with the first 12-items on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly agree." The 13th item (Global Improvement) asks, "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" (1) to "made things a lot worse" (5). Each of the subscales (Satisfaction With Therapy and Satisfaction With Therapist) range from 6 to 30, with higher scores indicating greater overall satisfaction. A total s
Satisfaction With Therapy (ST)
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
26.71
± 3.52
Waitlist Control
27.33
± 3.14
Satisfaction With Therapist (SWT)
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
28.86
± 1.86
Waitlist Control
27.75
± 3.27
Global Improvement (Item 13)
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
1.75
± 0.52
Waitlist Control
1.58
± 0.65
Number of Participants Who Completed Open-Ended Questions About the ProgramPrimary· Following completion of the intervention, up to 12 months
Intervention will be evaluated using 3 open-ended questions, including the following: "1) What was the most helpful part of the program?," "2) What was the least helpful part of the program?", and "3) What suggestions do you have for us to help improve the program?"
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
28
Waitlist Control
24
Percentage of Sessions Attended by Each ParticipantPrimary· Following completion of the intervention, up to 12 months
Treatment feasibility will be assessed by measuring the session attendance rate for each participant.
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
91.96
± 23.87
Waitlist Control
94.27
± 18.42
Treatment Acceptability QuestionnairePrimary· Following completion of the intervention, up to 12 months
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.
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
6.54
± 0.41
Waitlist Control
6.36
± 0.83
Use of Intervention StrategiesPrimary· Following completion of the intervention, up to 12 months
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 "every day" will be used.
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
2.35
± 0.83
Waitlist Control
2.67
± 1.24
Self-reported Use of the Mobile ApplicationPrimary· Following completion of the intervention, up to 12 months
Participants' use of the mobile application will be assessed using a measure developed specific to components of the proposed mobile application. Participants will be asked about how frequently they have used components of the mobile application 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.
Group
Value
95% CI
Behavioral Symptom Management for Young Adult Cancer Survivors
0.79
± 0.9
Waitlist Control
0.96
± 1.37
Change in Depressive Symptoms: PROMIS Depression Short FormSecondary· Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Depressive Symptoms will be assessed using the Patient Reported Outcomes Measurement Information System Depression Short Form-8a, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., "I felt sad," "I felt helpless") using a five-point scale ranging from 1 "never" to 5 "always." Items are summed and 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 de
Group
Value
95% CI
Pre-Intervention
50.3
± 10.2
Post-Intervention
48.7
± 9.6
Change in Anxiety: PROMIS Anxiety Short FormSecondary· Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Symptoms of Anxiety will be assessed using the Patient Reported Outcomes Measurement Information System Anxiety Short Form-8a, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., "I felt nervous," "I felt tense") using a five-point scale ranging from 1 "never" to 5 "always". Total scores are then converted to T-scores. Items are summed and 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
Group
Value
95% CI
Pre-Intervention
53.1
± 12
Post-Intervention
52.6
± 12
Change in Symptom Interference: Illness Intrusiveness Rating ScaleSecondary· Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Symptom interference will be assessed using the Illness Intrusiveness Rating Scale (IIRS). The 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). Items are rated on a 7-point scale from 1 "not very much" to 7 "very much." The total score ranges from 7 to 91, where a higher score indicates greater interference.
Group
Value
95% CI
Pre-Intervention
36.4
± 20
Post-Intervention
32.8
± 17.4
Change in Pain: Brief Pain InventorySecondary· Baseline and again 3, 6, 9, and 12 months following the baseline assessment; pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) 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 is computed as the average of seven items, which ask about the interference of pain across different li
Pain Severity
Group
Value
95% CI
Pre-Intervention
2.1
± 2
Post-Intervention
1.7
± 1.9
Pain Interference
Group
Value
95% CI
Pre-Intervention
2.2
± 2.3
Post-Intervention
1.9
± 2.3
Change in Fatigue: PROMIS Fatigue Short FormSecondary· Baseline and again 3, 6, 9, and 12 months following the baseline assessment, pre-intervention (baseline for Intervention, 6 months for Waitlist Control) and post-intervention (3 months for Intervention, 9 months for Waitlist Control) reported
Fatigue will be assessed using the Patient Reported Outcomes Measurement Information System Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"). Items are summed and converted to standardized t-scores with a mean of 50 and standard deviation of 10. A higher score indicates greater fatigue. T-scores of 55 to 60 indicate mild levels of fatigue, 60 to 70 indicates moderate levels of fatigue, and greater than 70 indicate severe levels of fatigue.
Group
Value
95% CI
Pre-Intervention
54
± 10.8
Post-Intervention
55.4
± 9.3
Sponsor's own description
Symptom interference is common for survivors of young adult cancer (aged 18-39 at diagnosis) and impacts their abilities to achieve normative life goals (e.g., education, careers, independence, romantic/social relationships) as well as adhere to recommended follow-up care. Assistance with symptom management has been rated by young adult survivors as an important and unmet healthcare need; however, skill-based symptom management interventions have typically been tested among older cancer survivors and have not targeted the unique developmental needs of those diagnosed as young adults. The proposed research advances the health and wellbeing of young adult cancer survivors by creating a developmentally appropriate hybrid in-person/mHealth behavioral symptom management intervention which addresses variables (i.e., symptoms and symptom interference) consistently linked to significant social, economic, and health burden.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 29 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04035447.