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Symptom Management for YA Cancer Survivors

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ClinicalTrials.gov Identifier: NCT04035447
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : August 4, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Cancer Young Adult Pain Psychological Distress Fatigue Breast Cancer Melanoma Hematologic Cancer Germ Cell Tumor Endocrine Cancer Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A two-arm, cluster RCT employing a wait-list control arm will be used. Six cohorts of YA survivors (n=10/cohort) will be randomized with equal allocation to the intervention or control arms.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Symptom Management for Survivors of Young Adult Cancer
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: Behavioral Symptom Management for Young Adult Cancer Survivors
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
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.

Active Comparator: Waitlist Control
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
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.




Primary Outcome Measures :
  1. Intervention Satistfaction: SSTS-R [ Time Frame: Following completion of the intervention, up to 12 months ]
    Intervention satisfaction will be assessed using the SSTS-R, a 13-item measure with the first 12-items on a five-point scale ranging from 1 "strongly disagree" to 5 "strongly disagree." The 13th item asks, "How much did the intervention help with your sypmtoms?" with 5 answer choices ranging from "made things a lot better" to made things a lot worse."

  2. Open-Ended Questions About the Program [ Time Frame: 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?"

  3. Session attendance [ Time Frame: Following completion of the intervention, up to 12 months ]
    Treatment feasibility will be assessed by measuring the session attendance rate for each participant.

  4. Treatment Acceptability Questionnaire [ Time Frame: 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).


  5. Change in Depressive Symptoms: PROMIS Depression Short Form [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    Depressive Symptoms will be assessed using the PROMIS Depression Short Form, 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."

  6. Change in Anxiety: PROMIS Anxiety Short Form [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    Symptoms of Anxiety will be assessed using the PROMIS Anxiety Short Form, 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".

  7. Change in Symptom Interference: Illness intrusiveness rating scale [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    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."

  8. Use of Intervention Strategies [ Time Frame: 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 "2 or more times a day" will be used.

  9. Self-reported use of the Mobile Application [ Time Frame: 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.


  10. Change in Pain: Brief Pain Inventory [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    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."

  11. Change in Fatigue: PROMIS Fatigue Short Form [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    Fatigue will be assessed using the PROMIS 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?"). Respon


Secondary Outcome Measures :
  1. Group Therapy Experiences Scale [ Time Frame: Following completion of the intervention, up to 12 months ]
    The 17-item Group Therapy Experiences Scale will be used to assess the level of cohesion among group members (e.g., development of positive relationships, comfort level with other group members). Items 1-16 are rated on a 5-point scale with 1 = "strongly agree" to 5 = "strongly disagree." Item 17 is an open-ended question, "was there something in the group today that helped or hindered you?"relationships, comfort level with other group members). Items are rated on a 4-point scale with 1= "strongly disagree" to 4= "strongly agree."

  2. Change in Social Isolation: PROMIS Social Isolation Scale [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The PROMIS Social Isolation Scale is a 6-item measure is used to assess social isolation. Participants are asked to rate each item (e.g., "I felt left out," "I feel that people avoid talking to me") on a scale from 1= "never" to 5= "always."

  3. Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    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."

  4. Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a is a 4-item scale. Participants rate their confidence in managing their symptoms during daily activities, with relationships with friends and family, in a public place, and working with their doctor to manage these symptoms on a scale from 1 = "I am not at all confident" to 5 "I am very confident."

  5. Change in Emotional Support: PROMIS Emotional Support-Short Form [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The PROMIS Emotional Support Short Form is a 6-item measure used to assess emotional support. Participants are asked to rate each item ("I have someone who will listen to me when I need to talk," "I have someone to talk with when I have a bad day") on a scale from 1= "never" to 5= "always."

  6. Change in Instrumental Support: PROMIS Instrumental Support-Short Form [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The PROMIS Instrumental Support Short Form is a 6-item measure used to assess instrumental support. Participants are asked to rate each item (e.g., "Do you have someone to take you to the doctor if you needed it?," "Do you have someone to prepare your meals if you are unable to do it yourself?") on a scale from 1= "never" to 5= "always."

  7. Change in Informational Support: PROMIS Informational Support-Short Form [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The PROMIS Informational Support Short Form is a 6-item measure used to assess informational support. Participants are asked to rate each item (e.g., "I have someone to turn to for suggestions about how to deal with a problem," "I have someone to give me information if I need it") on a scale from 1= "never" to 5= "always."


Other Outcome Measures:
  1. Sociodemographics [ Time Frame: Baseline ]
    Age, race/ethnicity, relationship status, employment status, occupation, income, and years fo education

  2. Disease Characteristics [ Time Frame: Baseline ]
    Disagnosis and treatment information

  3. Change in Activity: International Physical Activity Questionnaire [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The International Physical Activity Questionnaire is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven

  4. Change in Activity: Stanford LCAT [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The Stanford LCAT is a categorical item that asseses the type of physical activities participants do.

  5. Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT) [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = "not at all" to 4 = "very much."

  6. Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ) [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The AAQ is an 18-item questionnaire to track phsychological flexibility related to coping with cancer and cancer treatment. The scale ranges from 1 = "never true" to 7 "always true." Item is scored by adding all of the responses together.

  7. Changes in Living in Alignment with Values: The Valuing Questionnaire (VQ) [ Time Frame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment ]
    The VQ is a 10-item self-report questionnaire with a scale 0 = "not true at all" to 6 "completely true."



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035447


Contacts
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Contact: Caroline S Dorfman, PhD 919-416-3473 caroline.dorfman@duke.edu

Locations
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United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Caroline S Dorfman, PhD    919-416-3473    caroline.dorfman@duke.edu   
Contact: Rebecca Shelby, PhD    919-416-3410    rebecca.shelby@duke.edu   
Principal Investigator: Caroline S Dorfman, PhD         
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Caroline S Dorfman Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04035447    
Other Study ID Numbers: Pro00103249
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Cancer
Young Adult
Behavioral Symptom Management
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Hematologic Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Hematologic Diseases
Endocrine System Diseases