Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Behaviors and Mental Disorders

Gland and Hormone Related Diseases

Rare Diseases

Fatigue

Breast Neoplasms

Melanoma

Hematologic Neoplasms

Pain

Behavioral Symptoms

Neoplasms, Germ Cell and Embryonal

Endocrine Gland Neoplasms

Neoplasms by Histologic Type

Hematologic Diseases

Endocrine System Diseases

Germ Cells Tumors

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.

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.

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

Caroline S Dorfman

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.

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.

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.

Symptom Management for YA Cancer Survivors

Improving Symptom Management for Survivors of Young Adult Cancer

Age, race/ethnicity, relationship status, employment status, occupation, income, and years fo education

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

The Stanford LCAT is a categorical item that asseses the type of physical activities participants do.

The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = "not at all" to 4 = "very much."

The AAQ is a 7-item questionnaire to track psychological 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.

The VQ is a 10-item self-report questionnaire with a scale 0 = "not true at all" to 6 "completely true."

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."

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?"

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

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).

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."

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".

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."

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.

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.

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."

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

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."

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."

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."

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."

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."

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."

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."

National Cancer Institute (NCI)

Duke University

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Sarcoma

Lymphoma

Testicular Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Testicular Diseases

Gonadal Disorders

Soft Tissue Sarcoma

Lymphosarcoma

The education control condition will match AYA STEPS in delivery format \[videoconferencing, web-based platform, frequency (biweekly sessions)\], and session number (six) and length.

Participants will receive the AYA STEPS digital health intervention, which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist with intervention content accessed using a web-based platform.

AYA-specific educational information is delivered using video conferencing by a clinical psychologist over six sessions. Participants will receive a written manual providing tips for engaging with educational content as well as access to a website specific to the control arm, which will provide written, video, and pictorial information.

AYA Educational Information

The intervention provides cognitive-behavioral and patient activation theory-based skills designed to enhance AYA survivors' abilities to manage their high symptom burden and engage in follow-up health care. Sessions with the psychologist will focus on enhancing participants' abilities to apply intervention skills and engage in the AYA STEPS digital health intervention using motivational interviewing, goal setting, and problem-solving techniques. Participants will complete the six sessions over the 12 weeks of the AYA STEPS intervention.

AYA STEPS

The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care.

The investigators have developed an accessible digital health intervention, AYA STEPS (Symptom Management and Transitioning to Engagement with Post-Treatment Care for AYA Survivors), designed to enhance adolescent and young adult (AYA) cancer survivors' abilities to manage their high symptom burden and engage in follow-up health care. Informed by the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, AYA STEPS has been systematically and rigorously developed and refined through the PI's prior work (K08CA245107). AYA STEPS is organized into six remotely delivered sessions providing cognitive-behavioral and patient activation theory-based skills expected to lead to lower symptom burden and increased health care engagement by improving AYAs' self-efficacy for symptom management and activation. The investigators propose a randomized controlled trial to examine the efficacy of AYA STEPS compared to AYA educational information for improving symptom burden and health care engagement for AYA survivors (N=260) who received cancer care in diverse health care settings (i.e., rural, urban, medically underserved areas) across North Carolina. Self-efficacy and patient activation will be examined as mediators of intervention effects. The planned study has the potential to produce clinically impactful health benefits for an underserved and understudied group of cancer survivors who have significant symptom burden, experience barriers to care engagement, and have limited access to AYA-specific behavioral interventions.

Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors

It is the investigators' intention to make all data generated from this proposal freely available after it is de-identified. All direct respondent identifiers (e.g., names and addresses) will be removed and maintained in a secure file for future contact purposes. Respondent identifiers will not be shared. All other scientific data (scale composites) will be both preserved and shared. The following data will be preserved and shared: patient-reported data from study assessments, intervention utilization data collected via the study websites, healthcare utilization data collected from the health record, socio-demographic and medical data collected via patient report and health record, and scores on social determinant of health assessments (e.g., Area Deprivation Index). The investigators will make every effort to provide raw data in a non-proprietary format wherever possible to enhance reproducibility.

Health care utilization in the time since study enrollment will be assessed via review of participants' medical records to examine participants' receipt of general health screenings, cancer-related screenings, and follow-up care for late effects, in accordance with the 2024 National Comprehensive Cancer Network (NCCN) Adolescent and Young Adult (AYA) Guidelines.

The ADI will be calculated using participants home mailing addresses. The ADI is an indexed composite of 17 variables related to social determinants of health from the United States Census and American Community Survey that captures socioeconomic disadvantage at the census block group level. The index is reported as a percentile from 0% to 100%, with higher scores indicating higher levels of deprivation.

Participants' self-reports of their health care utilization since study enrollment will be collected to enhance the study team's ability to obtain chart review data.

The METER will be used to assess health literacy. Participants are asked to review a list of 40 words and check off those that they recognize as actual words.

The Everyday Discrimination Scale-Short Form is a 5-item scale that assesses participants' subjective experiences of daily discrimination, with patients indicating the frequency of discrimination experiences on a 6-point scale from "never" to "almost everyday." Patients who respond that they have experienced discrimination more frequently than "never" are asked what they think is the main reason(s) they experience(d) discrimination (e.g. ancestry, gender, race).

The 20-item uMARs will be adapted to obtain participants' evaluation of the AYA STEPS digital health platform and the AYA Educational Information website. Participants are asked to respond to questions regarding the quality of the mobile application on a 5-point scale from "inadequate" (1) to "excellent" (5). A total quality score is calculated as the mean of four objective quality subscales (engagement, functionality, aesthetics, and information quality). The uMARs also includes a subjective quality subscale.

Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the interventionists delivering either AYA STEPS or AYA Educational Information. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."

The AYA STEPS web-based portal and AYA Education Information website will track overall participant usage and content access for each of the respective sessions. The investigators will examine time spent accessing session content and time spent engaging in and completing home practice assignments.

The Brief Pain Inventory will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). This measures includes a body map on which the patient can mark the location(s) in which they are experiencing pain, as well as 8 questions on a scale of 0 to 10 with higher scores indicating worse pain severity or pain interference.

Fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (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?"), providing ratings on a scale from "not at all" (1) to "very much" (5).

Depressive symptoms will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).

The MDASI will be used to assess interference of symptoms in daily living (e.g., working, relations with other people, enjoyment of life) over the past month. The MDASI asks patients to rate the severity of 13 symptoms found frequently in patients with various cancers and treatment types on a scale from 0 (symptom "not present") to 10 (symptom "as bad as you can imagine"). This measure also includes 6 questions asking patients to rate the level of symptom interference in six domains (e.g., general activity, mood) on a scale from 0 (did not interfere) to 10 (interfered completely).

Symptoms of Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Responses are on a 5-point scale from "never" (1) to "always" (5).

The Patient Participation Questionnaire will be used to assess participants' health care participation and associated domains (i.e., receipt of information, communication, perceptions of their relationship with the medical team). Participants are asked to indicate their agreement with 17 items related to health care engagement on a 4 point scale: "to a great extent," "to some extent," "to a lesser extent," or "not at all." An additional item asks patients about their overall assessment of their involvement in their healthcare.

The MCCS patient subscale will be used to assess survivors' perceptions of their competency for communicating and participating in health care. The patient subscale includes 39 items on a scale of 1 to 7, with higher scores reflecting self-perception of better medical communication competence.

The 6-item Self-Efficacy for Managing Chronic Illness Scale will be used to assess participants' current confidence in their ability to prevent symptoms (e.g., pain, fatigue, distress) from interfering with life. Responses are on a 10-point scale from "not at all confident" (1) to "totally confident" (10).

The PAM is a 13-item measure used to assess survivors' knowledge, skills, and confidence that are central to managing their health and health care. Patients are asked to rate their agreement with statements about their health and health care on a 4 point scale from "strongly disagree" to "strongly agree." From these response a total PAM score is calculated on a scale of 0-100, with higher scores indicating higher levels of activation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Symptom Management for YA Cancer Survivors	NCT04035447	Cancer Young Adult Pain Psychological D... Fatigue Breast Cancer Melanoma Hematologic Can... Germ Cell Tumor Endocrine Cance...	Behavioral Symp...	18 Years - 39 Years	Duke University
Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors	NCT06371768	Cancer Breast Cancer Colorectal Canc... Sarcoma Lymphoma Testicular Canc...	AYA Educational... AYA STEPS	18 Years - 39 Years	Duke University

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