A Brief Patient-Controlled Intervention for a Symptom Cluster in Advanced Cancer

Co-occuring pain, fatigue, and sleep disturbance is a common symptom cluster among patients
with advanced cancer, diminishing functional status and quality of life.
Cognitive-behavioral (CB) strategies (e.g., relaxation, distraction, and imagery) are
effective treatments for each of these symptoms, and provide a logical choice in managing
all three co-occurring symptoms. CB strategies are thought to work psychologically by
reducing anxiety and stress, improving expectations for symptom outcomes, and enhancing
perceptions of personal control. Recent research also suggests a physiologic pathway, in
which CB strategies attenuate dysregulation in stress hormones and reduce proinflammatory
cytokines that contribute to symptom exacerbation. CB strategies are not equally effective
for all patients, with differences based on individual preferences and skills and concurrent
symptoms. Thus, training in a single strategy is not sufficient. Our previous work
demonstrates feasibility and initial efficacy of a patient-controlled cognitive-behavioral
(PC-CB) intervention in which patients receive information about their symptoms and
rationale for CB strategies, then self-administer their selection of various relaxation,
distraction, and imagery strategies via MP3 player, using the CB strategies at whatever time
and place they are needed. This brief intervention was designed to be mindful of the high
symptom burden, unpredictable treatment course, and often short life expectancy of persons
with advanced cancer. The purpose of this study is to test efficacy of the PC-CB
intervention in a randomized controlled trial and to test moderators and mediators of
intervention effects. The specific aims are (1) to test efficacy of the PC-CB intervention
on severity, distress, and interference with daily life from the pain, fatigue, sleep
disturbance symptom cluster, (2) to test proposed moderators (imaging ability, concurrent
symptoms) of PC-CB intervention effects, (3) to test psychological mediators (anxiety,
stress, outcome expectancy, perceived control) of PC-CB intervention effects, and (4) to
explore two types of physiological mediators (neuroendocrine stress hormones and indices of
inflammation) of PC-CB intervention effects. A sample of 198 adults receiving chemotherapy
for advanced breast, lung, colorectal, prostate, gynecologic or other solid tumor cancers
and experiencing pain, fatigue, and sleep disturbance will be recruited. Patients randomized
to the PC-CB intervention will receive a brief training session and instructions to use the
recorded CB strategies during 9-weeks of cancer treatment. Patients randomized to attention
control will receive instructions to use cancer educational recordings over the same period.
Measures of symptom severity and distress, symptom interference with daily life, and
proposed psychological and physiologic mediating variables will be completed at baseline and
the 3-week (primary) time point. Symptom outcome measures will be repeated at 6- and 9-week
(secondary) time points to evaluate longer term treatment effects.

Inclusion Criteria:

- Be 18 years of age or older.

- Have a diagnosis of advanced (metastatic or recurrent) lung, breast, colorectal,
prostate, gynecologic or other solid tumor cancer.

- Be receiving outpatient chemotherapy.

- Report all three symptoms (pain, fatigue, and sleep disturbance) as present in the
past week with worst severity rating ≥ 3 (0-10 scale) for at least two of the three
symptoms -

Exclusion Criteria:

- Pain that is post-operative (< 3 months since surgery) or severe neuropathic pain.

- Hospitalized for psychiatric reasons within the past 3 months.

- Unable to read, write, or understand English, or otherwise unable to complete study
procedures.