Symptom Management for YA Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Improving Symptom Management for Survivors of Young Adult Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04035447
• Other study ID #: Pro00103249
• Secondary ID: 1K08CA245107-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Cancer
• Endocrine Cancer
• Endocrine Gland Neoplasms
• Fatigue
• Germ Cell Tumor
• Hematologic Cancer
• Hematologic Neoplasms
• Melanoma
• Neoplasms, Germ Cell and Embryonal
• Pain
• Psychological Distress
• Young Adult

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Cancer Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographics	Age, race/ethnicity, relationship status, employment status, occupation, income, and years fo education	Baseline
Other	Disease Characteristics	Disagnosis and treatment information	Baseline
Other	Change in Activity: International Physical Activity Questionnaire	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	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other	Change in Activity: Stanford LCAT	The Stanford LCAT is a categorical item that asseses the type of physical activities participants do.	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other	Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)	The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = "not at all" to 4 = "very much."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other	Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ)	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.	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other	Changes in Living in Alignment with Values: The Valuing Questionnaire (VQ)	The VQ is a 10-item self-report questionnaire with a scale 0 = "not true at all" to 6 "completely true."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Primary	Intervention Satistfaction: SSTS-R	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."	Following completion of the intervention, up to 12 months
Primary	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
Primary	Session attendance	Treatment feasibility will be assessed by measuring the session attendance rate for each participant.	Following completion of the intervention, up to 12 months
Primary	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).	Following completion of the intervention, up to 12 months
Primary	Change in Depressive Symptoms: PROMIS Depression Short Form	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Primary	Change in Anxiety: PROMIS Anxiety Short Form	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".	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Primary	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Primary	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 "2 or more times a day" will be used.	Following completion of the intervention, up to 12 months
Primary	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
Primary	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Primary	Change in Fatigue: PROMIS Fatigue Short Form	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	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Secondary	Group Therapy Experiences Scale	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."	Following completion of the intervention, up to 12 months
Secondary	Change in Social Isolation: PROMIS Social Isolation Scale	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Secondary	Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Secondary	Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Secondary	Change in Emotional Support: PROMIS Emotional Support-Short Form	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Secondary	Change in Instrumental Support: PROMIS Instrumental Support-Short Form	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Secondary	Change in Informational Support: PROMIS Informational Support-Short Form	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."	Baseline and again 3, 6, 9, and 12 months following the baseline assessment