Williams LifeSkills - Cancer Caregiver Intervention

The pilot's specific aims are to:

1. Test the feasibility of (a) recruiting lung and breast cancer patients and their
caregivers (hereafter, "dyads) at the Duke Cancer Center (DCC) outpatient clinic; (b)
training interventionists to deliver the WLSCC protocol; (c) delivering the WLSCC
protocol by phone.

2. Examine the immediate and two-week impact of the WLSCC on caregiver quality of life,
anxiety and depression, caregiving preparedness, and social support as well as patient's
well-being (Functional Assessment of Cancer Therapy.

Design and Procedures The pilot is two-arm randomized intervention pilot (WLSCC vs. Usual
Care [UC]) with data collection at baseline (T1), immediately after training (T2), and 2
weeks after completing the training (T3). Caregivers will have an option to receive the WLCCC
protocol, should they wish, after the data collection period. A stratified randomization will
be conducted with stratifying variable being type of cancer and the block size will be 2.

The pilot setting is at the breast and thoracic cancer clinics at the DCC, Durham, NC. The
WLSCC will involve approximately six 30-minute phone sessions between the caregiver and
interventionist. The six calls will be delivered within three weeks of consent and will use
intervention scripts for standardization of delivery.

The training will use the WLS format to assess issues and discuss strategies for cancer care
including caregiver stress management. The context of discussion will be tailored by using
the cancer issues endorsed by the cancer patient at baseline data collection. In delivering
the interactive WLSCC training, the interventionist will preface each session by stating that
the protocol is designed to enable them to cope more effectively with demanding caregiving
situations and stressful life situations, to improve their relationships with others, and to
increase the proportion of positive thoughts and feelings in their daily lives. The
interventionist will frequently prompt the caregiver to raise questions that pertain to their
situation (using cancer symptoms endorsed by cancer patient at baseline survey). At the end
of each telephone session, the interventionist will request for the caregiver to complete log
entries to provide an opportunity to reflect or put into action the WLSCC psychosocial skills
taught in each session.

Subject Recruitment & Compensation:

The study team will review every week the list of adult patients who are scheduled for an
outpatient visit at DCC Breast Cancer Clinic and Thoracic Clinic. For those who initially
meet the criteria of aged 18 years and above and with primary breast or thoracic cancer
diagnosed less than a year of the scheduled visit, the team will send an invite letter by
mail to describe the study and invite their participation. A number will be provided that the
patient or caregiver can call to decline participation. If no phone call or voice message is
received on the opt-out number after 2 weeks of mailing the letter, the study staff will make
plans to approach patient and family/friend during the visit to determine further eligibility
for participation.

The study staff will visit the Duke Breast and Thoracic cancer clinic at least three times a
week. She/he will approach patients who have not opted out of the study to determine if the
family/friend accompanying the patient meets the definition of a caregiver for this study. If
yes, the study staff will explain the study including the possibility that the dyad maybe
assigned to either the WLSCC or UC group. If a working telephone number is assured and the
dyads show interest in study participation, consent will be obtained from the dyad. After
consent is obtained, baseline data (T1) for measures will be obtained. Using a laptop, the
study staff will access study database and measures using the secure Duke server. He/she will
ask questions in the baseline measures and responses will be directly entered to the study
database. Thereafter, the study staff will assign the dyad a number that is randomly
determined by a computer program. Each number from 1-40 will be assigned as either WLSCC or
UC. The interventionist will call the caregiver at the scheduled first session. Before the
first call ends, schedules for calls 2 to 6 will be established with the caregiver.

All follow-up data will be collected by phone. Follow-up data collection for T2 will be on
the date of the last phone call for the WLSCC group and 3 weeks after consent was obtained in
the UC group. T3 data will be collected two weeks after T2 data were collected in the WLSCC
group and five weeks after consent in the UC group.

Data Analysis & Statistical Considerations:

Descriptive statistics will be used to detail recruitment/retention rate, fidelity rate, and
the baseline demographic and clinical characteristics for the total sample and each group.
For each caregiver and patient outcome measure, descriptive statistics will be calculated at
baseline and at each follow-up. Plots of the individual trajectories (within-person scores
over time) will be used to identify the pattern(s) of change over time, and assess
between-person variability in baseline values (intercepts) and trajectories
(slopes).Hierarchical mixed-effects models will be used to delineate and summarize trends and
relationships in the data while nesting for dyads. This pilot study will focus on estimating
effective size for WLSCC rather than statistical significance testing dues to the exploratory
nature of the pilot study. When statistical testing is conducted, non-directional tests will
be performed with level of significance set at 0.10.

Inclusion Criteria:

- Patients are those with a confirmed medical diagnosis of breast or thoracic cancer
regardless of stage and followed at DCC for management.

- The cancer diagnosis should have been made less than a year from the next scheduled
appointment to the DCC.

- The caregiver is defined as unpaid individuals involved in assisting the cancer
patient with activities of daily living and/or medical tasks.

- Patients and caregivers must be able to hear, read, and write in English; oriented to
place, person, and time; and have an active telephone service, either cellular or
landline.

Exclusion Criteria:

- Excluding patients and caregivers who are less than 18 years of age