Breast Cancer, Cancer, Colorectal Cancer, Lymphoma, Sarcoma, Testicular Cancer
Conditions
Keywords
Cancer, Young Adult, Behavioral Symptom Management
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAYA Educational Information
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.
BEHAVIORALAYA STEPS
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.
Sponsors
Duke University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with one of the following cancers: 1) stage I-III breast cancer; 2) stage I-III colorectal cancer; 3) stage I-III sarcoma; 4) stage I-III Hodgkin or non-Hodgkin lymphoma; or 5) stage I-II testicular cancer * treated with curative intent and off therapy (with the exception of endocrine/hormonal therapy or oral targeted therapies used to prevent disease recurrence or progression) for the last three months * 1 to 5 years post-diagnosis * Able to speak and read English * Able to give informed consent
Exclusion criteria
* moderate or severe cognitive impairment * severe untreated mental illness (e.g., schizophrenia, substance use disorder) that would interfere with providing meaningful consent/study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity and interference as measured by Brief Pain Inventory | Baseline, 3 Months, 6 Months, 12 Months | 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 as measured by PROMIS Fatigue Scale | Baseline, 3 Months, 6 Months, 12 Months | 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). |
| Emotional distress as measured by PROMIS Depression Short Form | Baseline, 3 Months, 6 Months, 12 Months | 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). |
| Emotional distress as measured by PROMIS Anxiety Short Form | Baseline, 3 Months, 6 Months, 12 Months | 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). |
| Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference | Baseline, 3 Months, 6 Months, 12 Months | 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). |
| Health care engagement as measured by Patient Participation Questionnaire | Baseline, 3 Months, 6 Months, 12 Months | 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. |
| Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale | Baseline, 3 Months, 6 Months, 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale | Baseline, 3 Months, 6 Months, 12 Months | 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). |
| Patient activation as measured by Patient Activation Measure (PAM) | Baseline, 3 Months, 6 Months, 12 Months | 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. |
| Patient self-efficacy for managing chronic conditions as measured by the PROMIS Self-Efficacy for Managing Symptoms Short Form | Baseline, 3 Months, 6 Months, 12 Months | The 4-item PROMIS Self-Efficacy for Managing Symptoms will be used to assess participants' confidence in their ability to manage symptoms (e.g. during daily activities, in a public place). Items are scored on a 5-point Likert scale, with higher scores indicating greater confidence. |
| General patient self-efficacy as measured by the PROMIS General Self-Efficacy Short Form | Baseline, 3 Months, 6 Months, 12 Months | The 4-item PROMIS General Self-Efficacy will be used to assess participants' general confidence in their abilities (e.g., to solve problems and persist toward goals). Items are scored on a 5-point Likert scale, with higher scores indicating greater confidence. |
Countries
United States
Contacts
CONTACTCaroline S Dorfman, PhD
Outcome results
None listed