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CancerNCT04035447

Symptom Management for YA Cancer Survivors

A study testing Behavioral Symptom Management for Young Adult Cancer Survivors in people with Cancer and Young Adult, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Cancer, Young Adult, Pain
What is being tested?
Behavioral Symptom Management for Young Adult Cancer Survivors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
22 Jan 2020to 15 Jun 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 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • 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.
  • non-ambulatory
  • major mental illness (i.e., schizophrenia)
  • untreated or uncontrolled mental illness (i.e., bipolar disorder)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Cancer Institute

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Improving Symptom Management for Survivors of Young Adult Cancer

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.

Read the detailed description

More than 60,000 young adults (YAs) aged 18-39 are diagnosed with cancer in the US each year. Advances in treatment have yielded five year survival rates >70% suggesting that the majority of YAs will become long-term cancer survivors. Symptom (e.g., pain, fatigue, distress) interference is common for YA cancer survivors and impacts their abilities to achieve normative life goals (e.g., returning to work/school, achieving autonomy, pursuing social/romantic relationships) and adhere to recommended follow-up care. Symptom management has been identified as a significant issue in the transition to survivorship for YAs by the Institute of Medicine and National Cancer Institute, and assistance with symptom management is rated as an important and unmet need by YA survivors. Yet, behavioral symptom management interventions have not targeted the needs of those diagnosed as YAs. The proposed study aims to develop and test the feasibility and acceptability of a novel behavioral symptom management intervention designed for survivors of YA cancer (cancer types: hematologic, breast, or gastrointestinal cancers, melanoma, or germ cell tumors). The hybrid intervention will include inperson, group sessions and an integrated mobile application. The intervention will provide peer support while also teaching skills to improve symptoms, symptom interference, and self-efficacy for symptom management. The mobile application will assist with symptom monitoring, home skills practice, and connecting with group members. The preliminary version of the intervention will be guided by the research team's prior work developing and testing symptom management interventions for cancer survivors, national guidelines for YA oncology, consultation with an expert advisory board, and input from patient (n=20) and provider N=10) stakeholders. The intervention will be further refined following review by patient user testers (n=10). Next, feasibility, acceptability, and distributions of change over time as well as relationships between outcome variables will be examined through a pilot randomized clinical trial of the developed intervention. Participants (N=60) will be randomized to intervention or wait-list control arms. Primary study outcomes are symptom (pain, fatigue, distress) severity and symptom interference. Self-efficacy and support will also be examined as mediators of change in outcome variables. The proposed study has the potential to make several significant contributions by targeting an underserved group of cancer survivors, addressing a critical gap in care, and addressing variables consistently linked to social, economic, and health burden for YAs. It will also provide important information about approaches to identify, recruit, and retain YA cancer survivors in research and provide pilot data for a larger trial.

Being tested
Behavioral Symptom Management for Young Adult Cancer Survivors
Keywords
Cancer, Young Adult, Behavioral Symptom Management
Medical subject headings
Neoplasms, Pain, Fatigue, Breast Neoplasms, Melanoma, Hematologic Neoplasms, Neoplasms, Germ Cell and Embryonal, Endocrine Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Symptom Management for Young Adult Cancer SurvivorsBehavioural

    The intervention includes group sessions held over Zoom along with an integrated mobile application to provide participants with instruction in cognitive and behavioral strategies for managing symptoms (i.e., pain, fatigue, distress). The developed intervention includes 8 face-to-face group sessions (12 therapy hours). Sessions are delivered using a faded contact approach (i.e., sessions 1-6: weekly, sessions 7-8: biweekly). Participants receive secure access to a study-specific mobile application that includes: 1) audio and video files and brief text-based educational content reviewing strategies discussed during the groups; 2) the ability to self-monitor symptom severity; 3) the ability to connect with group members via a social networking platform; and 4) activity tracking synchronization.

Study groups in NCT04035447
Study groupRoleWhat they receive
Behavioral Symptom Management for Young Adult Cancer SurvivorsExperimentalThe intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms.
Receives: Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors
Waitlist ControlActive comparatorWaitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study.
Receives: Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R)

    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 score is calculated as the sum of the first twelve items, with possible scores from 12 to 60, with higher scores indicating greater overall satisfaction.

    Measured: Following completion of the intervention, up to 12 months

  2. Number of Participants Who Completed Open-Ended Questions About the Program

    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?"

    Measured: Following completion of the intervention, up to 12 months

  3. Percentage of Sessions Attended by Each Participant

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

    Measured: Following completion of the intervention, up to 12 months

  4. 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: Following completion of the intervention, up to 12 months

  5. 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 5 "every day" will be used.

    Measured: Following completion of the intervention, up to 12 months

  6. Self-reported Use of the Mobile Application

    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.

    Measured: Following completion of the intervention, up to 12 months

Secondary outcomes (5)

  1. Change in Depressive Symptoms: PROMIS Depression Short Form

    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 depression, and greater than 70 indicate severe levels of depression.

    Measured: 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

  2. Change in Anxiety: PROMIS Anxiety Short Form

    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 70 indicates moderate levels of anxiety, and greater than 70 indicate severe levels of anxiety.

    Measured: 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

  3. Change in Symptom Interference: Illness Intrusiveness Rating Scale

    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.

    Measured: 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

  4. Change in Pain: Brief Pain Inventory

    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 life domains (e.g., general activity, mood, relations with other people).

    Measured: 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

  5. Change in Fatigue: PROMIS Fatigue Short Form

    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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start22 Jan 2020
  3. Primary completion15 Jun 2024
  4. Study completion15 Jun 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
A two-arm, pilot RCT employing a wait-list control arm will be used. Six cohorts of YA survivors (n=10/cohort) are randomized within their cohort with equal allocation to the intervention or control arms. Randomization was stratified by gender.
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04035447
Sponsor's protocol ID
Pro00103249
Other IDs
1K08CA245107-01
Status last verified
Jun 2025
First submitted
24 Jul 2019
Last updated
29 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dorfman CS, Shelby RA, Stalls JM, Thomas SM, Arrato NA, Herold B, Somers TJ, Keefe FJ, Winger JG, Vilardaga JP, Oeffinger K. Improving symptom management for survivors of young adult cancer: rationale and study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Jun 8;10(1):87. doi: 10.1186/s40814-024-01510-7.

    PubMed 38851732

  • Dorfman CS, Shelby RA, Stalls JM, Somers TJ, Keefe FJ, Vilardaga JP, Winger JG, Mitchell K, Ehren C, Oeffinger KC. Improving Symptom Management for Survivors of Young Adult Cancer: Development of a Novel Intervention. J Adolesc Young Adult Oncol. 2023 Aug;12(4):472-487. doi: 10.1089/jayao.2022.0100. Epub 2022 Sep 30.

    PubMed 36178972

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Symptom Management for Young Adult Cancer Survivors in people with Cancer and Young Adult, 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 0 inclusion and 28 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 29 Jun 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 29 Jun 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?

Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) (time frame: Following completion of the intervention, up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04035447, which also lists 2 linked publications.

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 29 Jun 2025.

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