Post-chemotherapy Symptom Management SMART

Nearly 15.5 million Americans have survived cancer and virtually all have experienced
symptoms from cancer treatment. Numerous symptom management interventions have been tested
during active treatment, yet few have addressed the continuing fatigue, pain, depression,
etc. that endure following the end of treatment.

Existing post-treatment symptom management research has targeted survivors months after the
end of active treatment, overlooking the immediate post-treatment period. During this period,
some survivors have their symptoms resolve naturally (low need for intervention), while
others suffer from high symptom burden (high need for intervention), with 30% experiencing
depression. Sample: The sample will be 344 ethnically diverse (at least 30% Hispanic)
survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated
depression and co-morbid illnesses.

Design: The SMART design incorporates two interventions with proven efficacy and addresses
heterogeneity of survivors' responses by following the clinical logic of starting with one
intervention, assessing its success, and continuing it when effective. High need survivors
will be initially randomized to receive 1) weekly symptom assessment with referral for
elevated symptoms to a printed Symptom Management and Survivorship Handbook (SMSH) or 2) a
more intensive intervention adding SMSH to Telephone Interpersonal Counselling (TIP-C). After
4 weeks, non-responders to SMSH alone on depression will be re-randomized to continue SMSH
for 8 more weeks to allow for symptom resolution, or TIP-C will be added for the remaining 8
weeks. Specific Aims:

1. Test the effects of interventions on summed index of severity of 15 post-chemotherapy
symptoms (primary outcome) and symptom-specific responses and times to response (secondary
outcomes). Hypothesis 1.Survivors that starts with TIP-C+SMSH versus those that start with
SMSH alone created by the first randomization will have better primary and secondary outcomes
at weeks 1-13. Hypothesis 2. Among nonresponders to the SMSH alone after 4 weeks, survivors
in TIP-C+SMSH as compared to the SMSH alone group created by the second randomization will
have better primary and secondary outcomes at weeks 5-13.

Hypothesis 3. Self-efficacy and social support will mediate improvements in the primary
outcome at week 13.

Aim 2. Compare symptom outcomes of intervention sequences against the benchmark low need
group.

Exploratory Aim. Explore which survivor characteristics are associated with responses to the
SMSH alone during weeks 1-4 and optimal symptom outcomes during weeks 1-13. This will allow
us to determine tailoring variables to inform decision rules for choosing intervention
sequences for individual survivors in the future.

Inclusion Criteria:

- Survivors must have a new diagnosis or localized recurrence of solid tumor cancer

- Be finishing curative intent adjuvant chemotherapy or chemoradiation, and do not have
any subsequent cancer treatments planned, except for radiation therapy, hormonal
therapy or trastuzumab for breast cancer.

- 18 years of age or older

- Have access to a telephone

- Understand English or Spanish

- Are not currently receiving counseling and/or psychotherapy

Exclusion Criteria:

- Diagnosis of a psychotic disorder in medical record verified by the recruiter

- Nursing home resident

- Bedridden

- Currently receiving counseling and/or psychotherapy.