Trial Information

Couples and Cancer: Building Partner Efficacy in Caring

OBJECTIVES:

Primary

- Produce a multimedia program to deliver instructional content in massage for cancer
patients and their lay care partners.

- Determine the effects of the multimedia program on care partner esteem and stress and
on the frequency and duration of the care partner's provision of their assigned form of
support to the patient.

- Determine the effects of the multimedia program on patient symptom levels, functional
quality of life, perceived stress, and physiologic indices of stress.

Secondary

- Examine the impact of the multimedia program on care partner concerns about use of
touch as a form of support, and on self-efficacy in massage.

OUTLINE:

- Multimedia program production and screening (year 1): Patient/care partner dyads
representative of a broad spectrum of relationships participate in filming a multimedia
program about massage, acupressure, light touch, and massage safety precautions. The
multimedia program is titled, "Massage for People with Cancer: Simple Instruction for
Family and Friends." The program comprises a menu-driven DVD which allows the viewer to
select English or Spanish as well as individual chapters of content, and a manual keyed
to the DVD content. A different set of diverse patient/care partner dyads screen and
critique the multimedia program.

- Randomized controlled study of program's efficacy (year 2): Patient/care partner dyads
who reside in the same home are recruited. Dyads within each race/ethnic group are
stratified by patient total scores on the baseline FACT-G assessment. Dyads are then
randomized to 1 of 2 arms.

- Arm I (experimental intervention): Dyads attend an orientation meeting with other
dyads of their language group in order to meet the Oncology Massage Therapist
(OMT) and research assistant (RA) assigned to them during the study; watch the DVD
together and discuss it afterward; receive instructions for weekly data
collection; and receive explanation about the safety monitoring home visit and the
bi-weekly phone monitoring. Instructions for data collection include instructions
for the care partner to fill out a sample of the weekly Study Report card. Dyads
are given the DVD and manual to take home, and those who do not have a DVD player
are provided one. Dyads complete at least one massage over at least 20 minutes
once a week for 20 weeks in which they provide the techniques demonstrated in the
film. An OMT makes a home visit to each dyad during the first 2 weeks, and then as
needed, to monitor for understanding of and adherence to the relevant safety
precautions for the given patient. Dyads receive bi-weekly telephone monitoring
from an RA in order to encourage compliance with the weekly activity and monitor
for any adverse events or safety concerns that warrant another home visit by the
dyad's OMT (e.g., changes in medical treatment that call for changes in
precautions).

- Arm II (control intervention): For 4 weeks, care partners spend at least 20
minutes a week alone with the patient, reading to the patient from literature of
interest to the patient. The literature may be fiction, non-fiction, or poetry
that does not contain news or stressful subject matter. Dyads receive telephone
monitoring from their RA within the first week and then every 2 weeks thereafter
to encourage compliance, monitor for any adverse events or concerns, and respond
to questions about the project. At the end of the 4 weeks, dyads attend an
orientation meeting with the Principal Investigator, OMTs, and RAs. At this
meeting, dyads view the multimedia program and discuss precautions and any other
issues that may affect their utilization of the instruction. Dyads are then given
the multimedia program to take home, and a DVD player if they need one. A home
visit by an OMT is scheduled to assure the dyad understands and implements
relevant safety precautions. The dyads then participate in the use of the
intervention for the remaining 16 weeks of the study.

All participants in the study complete quality of life, perceived stress, and other
questionnaires at baseline and then at 4, 12, and 20 weeks. Demographic and patient medical
information is also collected. Saliva samples are collected from patients at baseline and
then at 4, 12, and 20 weeks to monitor cortisol and DHEA levels.