Clinical trial · Interventional
Stepped-Care Telehealth for Distress in Cancer Survivors
NCT03060096CI-TRIAL-00104202TelehealthcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Depressive Symptoms | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Recurrent Disease | — | UNRESOLVED | — |
| Sleep Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care Control | Other | — | UNRESOLVED |
| Moderate Anxiety/depression: Low Intensity Stepped care | Other | — | UNRESOLVED |
| Severe Anxiety/depression: High Intensity Stepped Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Moderate Anxiety/depression: Low Intensity Stepped care
- description
- participants with moderate symptoms (PHQ-9-14; GAD-7: 10-14) will be randomized to either low-intensity stepped care or enhanced usual care. Stepped care consist of a self-guided cognitive behavioral therapy (CBT) workbook to reduce anxiety and depressive symptoms and biweekly (every two weeks) check-in calls from research staff to assess changes in symptom severity/immediate need for psychiatric treatment and provide minimal support.
- interventionNames
- Other: Moderate Anxiety/depression: Low Intensity Stepped care
- type
- EXPERIMENTAL
- label
- Severe Anxiety/depression: High Intensity Stepped Care
- description
- Participants with severe symptoms (PHQ-9: 15-27; GAD-7: 15-21) will be randomized to high intensity stepped care (consist of a CBT workbook with accompanying psychotherapy by a Master's-level therapist delivered by telephone) or EUC. EUC consist of information about referrals/resources locally and nationally.
- interventionNames
- Other: Severe Anxiety/depression: High Intensity Stepped Care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.