A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors

Primary Objectives: To determine feasibility (recruitment, accrual, retention, adherence) of
a Randomized Control Trial (RCT) of a stepped-care mental health intervention (tailored to
symptom level) versus enhanced usual care in 90 post-treatment cancer survivors with moderate
or severe levels of emotional distress (anxiety and/or depressive symptoms).

Secondary Objectives:

1. To obtain preliminary data on the efficacy and variability of a stepped-care mental
health intervention (tailored to symptom level) versus enhanced usual care for reducing
emotional distress (anxiety and/or depressive symptoms) in 90 post-treatment cancer
survivors.

2. To obtain preliminary data on the efficacy and variability of a stepped-care mental
health intervention (tailored to symptom level) versus enhanced usual care for secondary
outcomes (sleep disturbance, fatigue, fear of recurrence, and Quality of Life (QOL)) in
90 post-treatment cancer survivors.

3. To determine costs associated with both stepped-care and enhanced usual care
interventions from the perspective of a healthcare provider. We will determine costs of
intervention implementation and health care utilization in all arms over the course of
the interventions.

4. To examine potential differential effects of the intervention on anxiety, depression,
sleep disturbance, fatigue, fear of recurrence, and QOL, by gender, age, race/ethnicity,
stratification arm (moderate, severe), and psychotropic medication use at baseline.

Inclusion Criteria:

1. Age ≥18 years

2. Score ≥10 on the Generalized Anxiety Disorder-7 (GAD-7) and/or a score ≥8 on the
Patient Health Questionnaire-9 (PHQ-9), indicating clinically significant anxiety or
depressive symptoms, respectively.

3. Past history of treated (newly diagnosed or recurrent) breast, colorectal, prostate,
gynecologic (only uterine and cervical) cancers (Stage I, II, or III) or any stage
lymphoma (Hodgkin's or non-Hodgkin's).

4. 6-60 months post-treatment (surgery, chemotherapy, radiation therapy, and/or
maintenance therapies) for cancer.Time frame applies to most recent completion of
treatment if participant had a cancer recurrence. It is acceptable to be on hormonal
therapies.

5. Residency in a rural zip code defined as below by the Rural-Urban Commuting Areas
(RUCA) Version 3.1. Residential zip codes are assigned a RUCA code based on size of
its largest population center and commuting patterns. A spreadsheet with eligibility
by zip code will be provided to all participating sites.

6. Must be able to speak and understand English.

7. Must have access to a telephone

Exclusion Criteria:

1. Current psychotherapy [regular appointment(s) with a psychologist, counselor, or
therapist within the last 30 days]

2. Self-reported active alcohol or substance abuse within the last 30 days

3. Past history of prostate cancer or non-Hodgkin's lymphoma with only active
surveillance (i.e., no surgery, chemotherapy, or radiation therapy)

4. Progressive cancer (must be considered no evidence of disease or stable)

5. Global cognitive impairment based on education-adjusted scores (details below) on the
Telephone Interview for Cognitive Status-modified

6. Self-reported psychotic symptoms in the last 30 days:

"Have you seen things that aren't really there or have you heard voices when no one
else was around within the last 30 days?")

7. Active suicidal ideation (currently reported suicidal plan and intent)

8. Any change in psychotropic medications within the last 30 days

9. Hearing loss that would preclude participating in telephone sessions (determined by
brief hearing assessment administered by research staff)