Symptom Management for YA Cancer Survivors

NCT04035447 | Completed Results DMC

• 2 other identifiers: Pro001032491K08CA245107-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Young Adult; Pain; Psychological Distress; Fatigue; Breast Cancer; Melanoma; Hematologic Cancer; Germ Cell Tumor; Endocrine Cancer

Keywords

Cancer; Young Adult; Behavioral Symptom Management

Outcome Measures

Primary Outcomes (6)

• 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.

  Following completion of the intervention, up to 12 months

• 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?"

  Following completion of the intervention, up to 12 months

• Percentage of Sessions Attended by Each Participant

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

  Following completion of the intervention, up to 12 months

• 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.

  Following completion of the intervention, up to 12 months

• 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.

  Following completion of the intervention, up to 12 months

• 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.

  Following completion of the intervention, up to 12 months

Secondary Outcomes (5)

• Change in Depressive Symptoms: PROMIS Depression Short Form

  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

• Change in Anxiety: PROMIS Anxiety Short Form

  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

• Change in Symptom Interference: Illness Intrusiveness Rating Scale

  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

• Change in Pain: Brief Pain Inventory

  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

• Change in Fatigue: PROMIS Fatigue Short Form

  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

Other Outcomes (12)

• Change in Activity: International Physical Activity Questionnaire

  Baseline and again 3, 6, 9, and 12 months following the baseline assessment

• Change in Activity: Stanford Leisure-Time Activity Categorical Item (LCAT)

  Baseline and again 3, 6, 9, and 12 months following the baseline assessment

• Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)

  Baseline and again 3, 6, 9, and 12 months following the baseline assessment

Study Arms (2)

Behavioral Symptom Management for Young Adult Cancer Survivors

EXPERIMENTAL

The 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.

Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors

Waitlist Control

ACTIVE COMPARATOR

Waitlist 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.

Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors

Interventions

Behavioral Symptom Management for Young Adult Cancer Survivors BEHAVIORAL

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.

Behavioral Symptom Management for Young Adult Cancer Survivors; Waitlist Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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
• Nonambulatory

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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.

  PMID: 38851732 DERIVED

• 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.

  PMID: 36178972 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain; Fatigue; Breast Neoplasms; Melanoma; Hematologic Neoplasms; Neoplasms, Germ Cell and Embryonal; Endocrine Gland Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Caroline Dorfman, PhD
• Organization: Duke University School of Medicine

caroline.dorfman@duke.edu

919-416-3473

Study Officials

• Caroline S Dorfman

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: January 22, 2020
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)