Multimedia Program About Massage Therapy for Cancer Patients and Their Care Partners - Full Text View

Sponsors and Collaborators:	Collinge and Associates National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00632398

Purpose

RATIONALE: A multimedia program that teaches massage therapy to cancer patients and their care partners may be effective in lowering stress, reducing symptoms, and improving quality of life. It is not yet known whether massage therapy is more effective than standard care for cancer patients and their care partners.

PURPOSE: This randomized phase II trial is studying how well a multimedia program about massage therapy works for cancer patients and their care partners.

Condition	Intervention	Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific	Other: educational intervention Other: questionnaire administration Procedure: acupressure therapy Procedure: massage therapy Procedure: psychosocial assessment and care Procedure: stress management therapy Procedure: therapeutic touch	Phase II

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	Couples and Cancer: Building Partner Efficacy in Caring

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia transthyretin amyloidosis

MedlinePlus related topics: Cancer Fungal Infections Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	240
Study Start Date:	March 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Maine
Collinge and Associates	Recruiting
Kittery Point, Maine, United States, 03905
Contact: William Collinge, PhD, MPH 207-439-8049
United States, Massachusetts
Greater Boston Chinese Golden Age Center	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Ka Lam 617-357-0226 ext. 233
Latin American Health Institute	Recruiting
Boston, Massachusetts, United States, 02116
Contact: Jorge Soler 617-350-6900 ext. 185

Sponsors and Collaborators

Collinge and Associates

National Cancer Institute (NCI)

Investigators

Principal Investigator:

William Collinge, PhD, MPH

Collinge and Associates

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Collinge and Associates ( William Collinge )
Study ID Numbers:	CDR0000587451, COLLINGE-06-200
Study First Received:	March 7, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00632398 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia

mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage I adult T-cell leukemia/lymphoma
stage I chronic lymphocytic leukemia
stage II adult T-cell leukemia/lymphoma
stage II chronic lymphocytic leukemia

Study placed in the following topic categories:

Blast Crisis
Mantle Cell Lymphoma
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Myelodysplastic Myeloproliferative Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Leukemia, Myeloid

Waldenstrom Macroglobulinemia
Plasmacytoma
Leukemia, Myeloid, Accelerated Phase
HIV Infections
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Precancerous Conditions
Blood Protein Disorders
Lymphoma, Follicular
Sezary Syndrome
Lymphoblastic Lymphoma
Lymphoma, B-Cell
Leukemia
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell

Additional relevant MeSH terms:

Precancerous Conditions
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Leukemia
Preleukemia
Hemorrhagic Disorders
Pathologic Processes
Syndrome
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Lymphoma
Disease
Neoplasms by Histologic Type

Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Myelodysplastic-Myeloproliferative Diseases
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 10, 2009