N/A
N=68
Stepped-Care Telehealth for Distress in Cancer Survivors
Anxiety · Depressive Symptoms · Sleep Disturbance · Recurrent Disease · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT03060096 ↗Enrolled (actual)
68
Serious AEs
4.4%
Results posted
Sep 2023
Primary outcome: Primary: Feasibility of Study Intervention Measured by Retention — 16; 12; 32 Participants — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Severe Anxiety/depression: High Intensity Stepped Care (Other); Moderate Anxiety/depression: Low Intensity Stepped care (Other); Enhanced Usual Care Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Study Intervention Measured by Retention |
16; 12; 32 | 0.29 |
| PRIMARY Feasibility of Study Intervention Measured by Adherence to Intervention |
0.82; 0.78 | 0.8 |
| PRIMARY Feasibility of Study Intervention Measured by Recruitment Rate |
68 | — |
| PRIMARY Feasibility of Study Intervention Measured by Accrual Rate |
0.5; 0.4; 0.9 | — |
| SECONDARY Longitudinal Changes in the Generalized Anxiety Disorder (GAD)-7 Score for Anxiety From Baseline to 13 Weeks |
-1.1; -8.6; -4.1 | — |
| SECONDARY Longitudinal Changes in the Patient Health Questionnaire (PHQ-9) Score for Depression From Baseline to 13 Weeks |
-2.0; -8.8; -3.2 | — |
| SECONDARY Number of Participants With Moderate of Severe Depression (PHQ-9) or Anxiety (GAD-7) at 13 Weeks |
0; 2; 5 | — |
| SECONDARY Longitudinal Changes in the Insomnia Severity Index (ISI) From Baseline to 13 Weeks. |
-3.1; -7.7; -2.9 | — |
| SECONDARY Longitudinal Changes in the PROMIS Fatigue Scale From Baseline to 13 Weeks |
0.1; -5.6; -3.1 | — |
| SECONDARY Longitudinal Changes in the Fear of Recurrence Inventory Severity Subscale From Baseline to 13 Weeks |
-1.7; -4.7; -3.1 | — |
| SECONDARY Longitudinal Changes in the Health Status Questionnaire (SF-36) From Baseline to 13 Weeks |
3.4; 12.2; 4.7; -1.1; 1.2; 0.7 | — |
| SECONDARY Longitudinal Changes in the Impact of Events Scale-Revised (IES-R) From Baseline to 13 Weeks |
-0.3; -1.8; -0.6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Score ≥10 on the GAD-7 and/or a score ≥8 on the PHQ-9, indicating clinically significant anxiety or depressive symptoms, respectively.
- Past history of treated Stage I, II, or III (newly diagnosed or recurrent) breast, colorectal, prostate, gynecologic (to include uterine and cervical) cancers and non-Hodgkin's lymphoma.
- 6-60 months post-treatment (surgery, chemotherapy, and/or radiation therapy) for cancer. Time frame applies to most recent completion of treatment if participant had a cancer recurrence. It is acceptable to be on maintenance or hormonal therapies.
- Participant resides in California, Georgia, Illinois, Kansas, Michigan, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, Tennessee, or Wisconsin
- Study-trained therapist in the state where the participant resides.
- Must be able to speak and understand English.
- Must have access to a telephone
Exclusion Criteria
- Current psychotherapy [regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days prior to randomization].
- Self-reported active alcohol or substance abuse within the last 30 days.
- Past history of prostate cancer or non-Hodgkin's lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy).
- Diagnosis of a second malignancy (except for non-melanoma skin cancers) after a previous diagnosis of breast, colorectal, gynecologic cancers and non-Hodgkin's lymphoma
- Progressive cancer (must be considered no evidence of disease or stable)
- Self -reported history of a diagnosis of dementia from a healthcare provider.
- Self -reported psychotic symptoms in the last 30 days prior to randomization
- Active suicidal ideation (currently reported suicidal plan and intent).
- Any change in psychotropic medications within the last 30 days.
- Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff)
- Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the course of the study.
Data sourced from ClinicalTrials.gov (NCT03060096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.