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Stepped-Care Telehealth for Distress in Cancer Survivors
NA trial testing Severe Anxiety/depression: High Intensity Stepped Care in Anxiety in 68 participants. Completed in 29 July 2022.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 68 |
| Start date | 19 July 2018 |
| Primary completion | 29 July 2022 |
| Estimated completion | 29 July 2022 |
| Sites | 166 locations across United States |
Wake Forest University Health Sciences
18 and older, any sex, with Anxiety or Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Study retention will be estimated by the number of participants who complete the Week 7 and 13 visits
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | 16 | |
| Severe Anxiety/Depression: High Intensity Stepped Care | 12 | |
| Enhanced Usual Care Control (EUC) | 32 |
Intervention adherence will be estimated as the mean proportion of therapy (high-intensity intervention) or check-in (low-intensity intervention) sessions each participant completes.
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | 0.82 | ± 0.34 |
| Severe Anxiety/Depression: High Intensity Stepped Care | 0.78 | ± 0.37 |
Recruitment rate will be determined by the number of eligible participants who met all eligibility criteria and percent who agreed to participate.
| Group | Value | 95% CI |
|---|---|---|
| Recruitment Rate of Entire Study | 68 |
The accrual rate is determined by dividing the overall number of participants recruited in each arm by the total span of 38 months between the start of the first screening for enrollment and the time the study closed to accrual.
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | 0.5 | |
| Severe Anxiety/Depression: High Intensity Stepped Care | 0.4 | |
| Enhanced Usual Care Control (EUC) | 0.9 |
The Generalized Anxiety Disorder (GAD) -7 is a self-report measure of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of Generalized Anxiety Disorder (GAD). Longitudinal changes in the GAD-7 will be measured in participants to evaluate the effectiveness of the intervention in reducing anxiety. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. The first 7 questions are summed to create a total score ranging from 0 to 21. Higher scores reflect greater anxiety severity. Scores above 10 are considered to be in the clinical range.
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | -1.1 | -3.8 – 1.5 |
| Severe Anxiety/Depression: High Intensity Stepped Care | -8.6 | -11.4 – -5.7 |
| Enhanced Usual Care Control (EUC) | -4.1 | -6.3 – -1.8 |
The PHQ-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder where participants rate how often they experienced 9 symptoms over past 2 weeks. Patients select 1 of 4 numbers with "0" indicating not all, to "3" indicating nearly everyday. Longitudinal changes in the PHQ-9 will be measured in participants to evaluate the effectiveness of the intervention in reducing depression. The possible range is 0-27. A larger score represents more severe depression level.
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity | -2.0 | -4.2 – 0.4 |
| Severe Anxiety/Depression: High Intensity | -8.8 | -11.3 – -6.3 |
| Enhanced Usual Care Control (EUC) | -3.2 | -5.1 – -1.2 |
A combined variable will be created that indicates if a participant had moderate/severe depression or anxiety at mid- or post-intervention. This is defined as either PHQ-9 or GAD-7 greater than or equal to 15.
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | 0 | |
| Severe Anxiety/Depression: High Intensity Stepped Care | 2 | |
| Enhanced Usual Care Control (EUC) | 5 |
Measure Description: The Insomnia Severity Index (ISI) is 7-item self-report measure of type and severity of insomnia symptoms, including problems with sleep onset, sleep maintenance, or early morning awakening; satisfaction with current sleep pattern; interference with daily functioning; noticing impairment attributed to sleep problems; and level of concern or distress caused by the sleep problem. Each of the seven items is scored on a 5-point scale, ranging from 0 (lowest) to 4 (highest). The sum of the scores for all seven items yields a total score, which falls within a range of 0 to 28. A
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | -3.1 | -6.9 – 0.6 |
| Severe Anxiety/Depression: High Intensity Stepped Care | -7.7 | -11.8 – -3.7 |
| Enhanced Usual Care Control (EUC) | -2.9 | -6.1 – 0.3 |
The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a is a measure of the experience of fatigue and the impact of fatigue on activities across multiple domains. There are eight items rated on a scale of 1(never) to 5 (always) based on how often fatigue was experienced over the last 7 days. The sum of these eight items ranges from a minimum of 8 to a maximum of 40, with higher scores representing more fatigue. This total score is then converted into a t-score based on the PROMIS 8a adult conversion table. The smallest t score is 33.1 and the largest t score
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | 0.1 | -5.0 – 5.2 |
| Severe Anxiety/Depression: High Intensity Stepped Care | -5.6 | -11.1 – -0.1 |
| Enhanced Usual Care Control (EUC) | -3.1 | -7.4 – 1.3 |
The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of cancer recurrence. Range is 0 to 36 with higher values representing higher fear of recurrence.
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity | -1.7 | -6.3 – 2.9 |
| Severe Anxiety/Depression: High Intensity | -4.7 | -9.6 – 0.3 |
| Enhanced Usual Care Control (EUC) | -3.1 | -7.0 – 0.8 |
The Health Status Questionnaire (SF-36) functions as a self-reporting tool designed to evaluate an individual's quality of life. It consists of 36 items and is organized into eight subscales. Each subscale score is then translated into a linear scale that spans from 0 to 100. A higher score means enhanced quality of life. Additionally, the questionnaire incorporates two domains as mental health component and physical health component. These domains are the results of linear aggregation from the 8 subscales and transforming into T score metric. In these metrics, the t score has a mean of 50 and
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | 3.4 | -3.0 – 9.7 |
| Severe Anxiety/Depression: High Intensity Stepped Care | 12.2 | 5.1 – 19.2 |
| Enhanced Usual Care Control (EUC) | 4.7 | -0.7 – 10.1 |
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity Stepped Care | -1.1 | -7.3 – 5.2 |
| Severe Anxiety/Depression: High Intensity Stepped Care | 1.2 | -5.7 – 8.1 |
| Enhanced Usual Care Control (EUC) | 0.7 | -4.6 – 6.0 |
The Impact of Events Scale - Revised (IES-R) is a 22-item self-report measure of cancer related distress. The IES-R assesses the frequency with which respondents experience intrusive thoughts, avoidant behaviors, and autonomic arousal specific to one's thoughts and feelings about cancer over the past week. Each item is rated on a 5-point scale ranging from 0("not at all") to 4("extremely"). The higher grade indicates greater stress. IES- R total score is the sum of the means of the three subscale scores. IES- R total score ranges from 0 to 12. The higher scores indicate higher cancer distress.
| Group | Value | 95% CI |
|---|---|---|
| Moderate Anxiety/Depression: Low Intensity | -0.3 | -1.7 – 1.0 |
| Severe Anxiety/Depression: High Intensity | -1.8 | -3.2 – -0.4 |
| Enhanced Usual Care Control (EUC) | -0.6 | -1.7 – 0.49 |
Time frame: 13 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Moderate Anxiety/Depressio… | Severe Anxiety/Depression:… | Enhanced Usual Care Contro… |
|---|---|---|---|---|
| SAE | Surgical and medical procedures | — | — | — |
| SAE | Vascular disorders | — | — | — |
| SAE | Renal and urinary disorders | — | — | — |
| Reaction | System | Moderate Anxiety/Depressio… | Severe Anxiety/Depression:… | Enhanced Usual Care Contro… |
|---|---|---|---|---|
| Depression | Psychiatric disorders | — | — | — |
| Worsening Anxiety | Psychiatric disorders | — | — | — |
| Suicidal ideation | Psychiatric disorders | — | — | — |
| Shoulder pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Diarrhea on and off | Gastrointestinal disorders | — | — | — |
Most-reported serious reactions: SAE, SAE, SAE.
Data from ClinicalTrials.gov NCT03060096 adverse events section.
Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose of this study is to test a stepped-care approach tailored to symptom severity based on recent American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community oncology settings and to examine intervention costs. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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