Multimedia Training for Family Caregivers in Use of Touch and Massage in Supportive Cancer Care

NCT00632398 | Completed Phase 2

• 2 other identifiers: CDR0000587451COLLINGE-06-200
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer

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

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

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.

Behavioral: Attention control (reading)

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.

Behavioral: Touch, Caring and Cancer DVD program

Interventions

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

Attention control (reading)

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.

Touch, Caring and Cancer DVD program

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Cancer patient and their care partner with any of the following characteristics: * African American * Asian * Hispanic or Latino * Caucasian * Intimate relationship * Parent/adult child relationship * Same-sex couple relationship * Male or female * Patient must have undergone conventional cancer treatment within the past 6 months PATIENT CHARACTERISTICS: * Speaks, reads, and writes English, Spanish, or Chinese (care partner) * Speaks, reads, and writes English, Spanish, or Chinese (patient) * No contraindication, such as serious mental illness or physical inability, that would preclude study participation (patient or care partner) PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Collinge and Associates, Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Collinge and Associates

Kittery, Maine, 03904, United States

Location

Greater Boston Chinese Golden Age Center

Boston, Massachusetts, 02111, United States

Location

Latin American Health Institute

Boston, Massachusetts, 02116, United States

Location

Related Publications (2)

• 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.

  PMID: 22281309 BACKGROUND

• 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.

  PMID: 23262808 RESULT

MeSH Terms

Conditions

Neoplasms; Caregiver Burden

Interventions

Touch

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• William Collinge, PhD, MPH

  Collinge and Associates, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 10, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

US (3)