Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care
Condition: Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: A multimedia education program for family caregivers that teaches simple methods
      of touch and massage for the comfort of cancer patients at home may be effective in lowering
      stress, reducing symptoms, and improving quality of life for patients; and may improve
      caregiver satisfaction and self-efficacy.

      PURPOSE: This randomized phase II trial is studying how well multimedia instruction of
      caregivers in use of touch and massage works for cancer patients and their care partners.
    

Detailed description: 
      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.
    

Intervention name(s): Attention control (reading); Touch, Caring and Cancer DVD program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Caregivers read to the patient from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks; DVD- and manual-based instruction for caregivers and patients in the use of touch and massage techniques as supportive care in cancer, including: preparation for a session, safety precautions related to cancer and its treatments, communication about touch, centering to calm the mind; manual techniques for the head, neck, shoulders, back, feet and hands to promote relaxation; and acupressure for pain, nausea and anxiety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: massage; oncology massage; palliative care; supportive care; integrative oncology; informal caregiving; spouse caregiving; family caregiving; caregiver education; psychosocial oncology; caregiver stress; coping with cancer; quality of life; end of life care