Stepped-Care Telehealth for Distress in Cancer Survivors
(Telehealth Trial)

Recruiting in Palo Alto (17 mi)

+165 other locations

Overseen bySuzanne Danhauer, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Suzanne Danhauer, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

Inclusion Criteria

Must have access to a telephone

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.

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Exclusion Criteria

You currently have a plan to harm yourself.

You experienced symptoms of psychosis (such as delusions or hallucinations) within the last 30 days before the start of the study.

You have had another type of cancer in the past, except for non-melanoma skin cancers.

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Treatment Details

Interventions

Enhanced Usual Care Control (Behavioural Intervention)
High Intensity Stepped Care (Behavioural Intervention)
Low Intensity Stepped care (Behavioural Intervention)

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Severe Anxiety/depression: High Intensity Stepped CareExperimental Treatment1 Intervention

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.

Group II: Moderate Anxiety/depression: Low Intensity Stepped careExperimental Treatment1 Intervention

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.

Group III: Enhanced Usual Care Control (EUC)Active Control1 Intervention

Participants randomized to EUC will receive information about local referrals/resources (support groups, mental health providers, etc.). They will also be provided "Facing Forward: Life after Cancer Treatment," a book developed by the NCI to assist with transition from active treatment to survivorship. Participants will receive information on self-help workbooks for anxiety \& depressive symptoms. EUC control will receive a copy of the CBT workbook on completion of the study.