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| ID | Type | Description | Link |
|---|---|---|---|
| COLLINGE-06-200 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention control (reading) | Active Comparator | Caregivers read to patients from literature of the patient's choice for recommended 20 minutes at least 3 times per week for 4 weeks. |
|
| Touch, Caring and Cancer DVD program | Experimental | Caregivers apply the instruction of the Touch, Caring and Cancer DVD program for patients for recommended 20 minutes at least 3 times per week for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attention control (reading) | Behavioral | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute effects of massage on patient symptoms as assessed by the weekly Study Report card | ||
| Longitudinal effects of massage on patient symptoms as assessed by the weekly Study Report card | ||
| Frequency and duration of care partner providing the assigned form of support as assessed by the weekly Study Report card | ||
| Care partner esteem as assessed by a 7-item esteem subscale of the Caregiver Reaction Assessment at baseline and then at 12 and 24 weeks | ||
| Patient physiological stress measures as assessed by measuring diurnal variation in cortisol and DHEA at baseline and then at 12 and 24 weeks | ||
| Patient and care partner perceived stress as assessed by the Perceived Stress Scale at baseline and then at 12 and 24 weeks | ||
| Patient functional quality of life as assessed by FACT-G at baseline and then at 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Care partner self-efficacy and concerns about using touch as support as assessed by an investigator-generated survey at baseline and then at 12 and 24 weeks | ||
| Care partner utilization of multimedia materials as assessed by the weekly Study Report card |
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DISEASE CHARACTERISTICS:
Cancer patient and their care partner with any of the following characteristics:
Patient must have undergone conventional cancer treatment within the past 6 months
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| William Collinge, PhD, MPH | Collinge and Associates, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collinge and Associates | Kittery | Maine | 03904 | United States | ||
| Greater Boston Chinese Golden Age Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22281309 | Background | Collinge W, MacDonald G, Walton T. Massage in supportive cancer care. Semin Oncol Nurs. 2012 Feb;28(1):45-54. doi: 10.1016/j.soncn.2011.11.005. | |
| 23262808 | Result | Collinge W, Kahn J, Walton T, Kozak L, Bauer-Wu S, Fletcher K, Yarnold P, Soltysik R. Touch, Caring, and Cancer: randomized controlled trial of a multimedia caregiver education program. Support Care Cancer. 2013 May;21(5):1405-14. doi: 10.1007/s00520-012-1682-6. Epub 2012 Dec 21. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014110 | Touch |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Touch, Caring and Cancer DVD program | Behavioral | 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. |
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| Boston |
| Massachusetts |
| 02111 |
| United States |
| Latin American Health Institute | Boston | Massachusetts | 02116 | United States |