N/A
N=61
Symptom Management for YA Cancer Survivors
Cancer · Young Adult · Pain · Psychological Distress · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT04035447 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) — 26.71; 27.33; 28.86; 27.75 scores on a scale — p=0.519
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Symptom Management for Young Adult Cancer Survivors (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) |
26.71; 27.33; 28.86; 27.75; 1.75; 1.58 | 0.519 |
| PRIMARY Number of Participants Who Completed Open-Ended Questions About the Program |
28; 24 | — |
| PRIMARY Percentage of Sessions Attended by Each Participant |
91.96; 94.27 | 0.696 |
| PRIMARY Treatment Acceptability Questionnaire |
6.54; 6.36 | 0.350 |
| PRIMARY Use of Intervention Strategies |
2.35; 2.67 | 0.274 |
| PRIMARY Self-reported Use of the Mobile Application |
0.79; 0.96 | 0.600 |
| SECONDARY Change in Depressive Symptoms: PROMIS Depression Short Form |
50.3; 48.7 | 0.1848 |
| SECONDARY Change in Anxiety: PROMIS Anxiety Short Form |
53.1; 52.6 | 0.6153 |
| SECONDARY Change in Symptom Interference: Illness Intrusiveness Rating Scale |
36.4; 32.8 | 0.0563 |
| SECONDARY Change in Pain: Brief Pain Inventory |
2.1; 1.7; 2.2; 1.9 | 0.0265 sig |
| SECONDARY Change in Fatigue: PROMIS Fatigue Short Form |
54; 55.4 | 0.3512 |
Summary
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.
Eligibility Criteria
Young Adult Cancer Survivors Participating in Intervention Development Interviews
Eligibility Criteria
- Diagnosed with hematologic, breast, gastrointestinal, or endocrine cancers, melanoma, or germ cell tumors
- Diagnosed with cancer as a young adult
- Under the care of a medical provider at the Duke Cancer Institute
- Completed curative treatment involving multimodal therapy within the last five years
- Able to speak and read English
- Able to give informed consent
Exclusion Criteria
- Nonambulatory
- Major mental illness, i.e., schizophrenia
- Untreated or uncontrolled mental illness, i.e., bipolar
- Residence greater than 100 miles from the research site
Medical Providers Participating in Intervention Development Interviews Eligibility criteria
o Provide care to young adult cancer survivors at the Duke Cancer Institute
Young Adult Cancer Survivor User Testers
Eligibility Criteria
- Diagnosed with hematologic, breast, gastrointestinal cancers, or endocrine cancers, melanoma, or germ cell tumors
- Diagnosed with cancer as a young adult
- Under the care of a medical provider at the Duke Cancer Institute
- Completed curative treatment involving multimodal therapy within the last five years
- Able to speak and read English
- Able to give informed consent
Exclusion Criteria
- Nonambulatory
- Major mental illness, i.e., schizophrenia
- Untreated or uncontrolled mental illness, i.e., bipolar
- Residence great than 100 miles from the research site
RCT Participants
Eligibility Criteria:
- diagnosed with cancer as a YA (aged 18-39)
- diagnosis of hematologic, breast, endocrine or gastrointestinal cancer, melanoma, or germ cell tumor
- receiving care at the Duke Cancer Institute
- completed curative treatment involving multimodal therapy within the last 2 years
- able to speak/read English; and able to give informed consent.
Exclusion Criteria
- non-ambulatory
- major mental illness (i.e., schizophrenia)
- untreated or uncontrolled mental illness (i.e., bipolar disorder)
Data sourced from ClinicalTrials.gov (NCT04035447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.