Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Collinge, PhD, Collinge and Associates
ClinicalTrials.gov Identifier:
NCT00632398
First received: March 7, 2008
Last updated: September 8, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Behavioral: Attention control (reading)
Behavioral: Touch, Caring and Cancer DVD program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Couples and Cancer: Building Partner Efficacy in Caring

Resource links provided by NLM:


Further study details as provided by Collinge and Associates, Inc.:

Primary Outcome Measures:
  • Acute effects of massage on patient symptoms as assessed by the weekly Study Report card [ Designated as safety issue: No ]
  • Longitudinal effects of massage on patient symptoms as assessed by the weekly Study Report card [ Designated as safety issue: No ]
  • Frequency and duration of care partner providing the assigned form of support as assessed by the weekly Study Report card [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Patient physiological stress measures as assessed by measuring diurnal variation in cortisol and DHEA at baseline and then at 12 and 24 weeks [ Designated as safety issue: No ]
  • Patient and care partner perceived stress as assessed by the Perceived Stress Scale at baseline and then at 12 and 24 weeks [ Designated as safety issue: No ]
  • Patient functional quality of life as assessed by FACT-G at baseline and then at 12 and 24 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • Care partner utilization of multimedia materials as assessed by the weekly Study Report card [ Designated as safety issue: No ]

Enrollment: 228
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Attention control (reading)
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)
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
Experimental: Touch, Caring and Cancer DVD program
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632398

Locations
United States, Maine
Collinge and Associates
Kittery, Maine, United States, 03904
United States, Massachusetts
Greater Boston Chinese Golden Age Center
Boston, Massachusetts, United States, 02111
Latin American Health Institute
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
Collinge and Associates, Inc.
Investigators
Principal Investigator: William Collinge, PhD, MPH Collinge and Associates, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: William Collinge, PhD, President, Collinge and Associates
ClinicalTrials.gov Identifier: NCT00632398     History of Changes
Other Study ID Numbers: CDR0000587451, COLLINGE-06-200
Study First Received: March 7, 2008
Last Updated: September 8, 2012
Health Authority: United States: Federal Government

Keywords provided by Collinge and Associates, Inc.:
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

ClinicalTrials.gov processed this record on November 25, 2014