Cristina Hendrix, DNS

The goals of the study are to investigate the needs of older (age 60+) caregivers caring for adults with cancer at 1-week and 2 weeks following hospital discharge and to explore strategies that may assist caregivers in their home caregiving needs. This study will explore how these needs vary based on caregiver spirituality and relationship with the care recipient.

The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which are the hematological and non-hematological malignancy units at Duke University Medical Center (DUMC) respectively. Results of this study will lay the groundwork for creating tailored interventions for caregivers that are compatible to their preferences and more responsive to their needs.

Baseline demographic data about the caregiver and patient will be collected at patient beside prior to hospital discharge. Qualitative interviews will be conducted with the cancer caregivers in their home at 1-week after their loved one was discharged from the hospital, and at 2-weeks after discharge from the hospital. This study utilizes a qualitative descriptive design.

Older Cancer Caregiver Needs Post Hospital Discharge

Needs of Older Caregivers of Adults With Cancer In the First 2 Weeks Following Hospital Discharge

Explore the needs (e.g., psychosocial) of older adults caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these needs vary by spirituality and relationship to the care recipient.

Identify the strategies used by older caregivers during the first and second weeks after hospital discharge, and determine how these strategies vary by spirituality and relationship to the care recipient.

Describe the preferences of support and assistance (e.g., family/friends) of older caregivers in caring for a loved one with cancer at home during the first and second weeks after hospital discharge, and determine how these preferences vary by spirituality and relationship to the care recipient.

Explore whether caregiver needs and preferences vary with time (1 week versus 2 weeks post hospital discharge).

The Reed Foundation, Ruth Landes Memorial Research Fund

Duke University

Behaviors and Mental Disorders

All Conditions

Anxiety Disorders

Depressive Disorder

Depression

Behavioral Symptoms

This group receives the massage intervention for a period of six weeks. Children and parents are asked to journal weekly for the six week period.

The control group does not receive any massage intervention during the initial six weeks of the study. The children are asked to journal during this six week period.

Children will receive a 10-15 minute massage seated (clothed), or in bed (clothed or unclothed) each day using the following protocol: stroking, effleurage, petrissage, muscle squeezing, effleurage, stroking. Massaged areas can include the back, arms and legs.

Parents will receive a one hour educational session with a Massage Therapist, a DVD, and written materials that all illustrate the required protocol.

Massage

Children will complete weekly journals about their feelings. These journals will either be drawn or written based on the preference of the child. Parents will complete a weekly journal outlining the number of massages given to their child, barriers that prevented massage, and their experience of giving the massage.

Journaling

Trish Dryden, RMT, M.Ed

Stacey Neilson, BA (Hons), RMT

Linda Churcher, CCRP

Ronda Blasco

Sabine Moritz, Dipl. Biol., M.Sc

Sunita Vohra, MD, FRCPC, M.Sc

Dawn Davies, MD, FRCPC

Adrienne D Witol, Psy.D., C.Psych

Andrea M Laizner, RN, Ph.D

Lyse Lussier

Janet Kahn, LMT, Ph.D.

Amanda Baskwill, RMT

Linda Curcher, CCRP

Elizabeth Barberree, RMT

The purpose of this study is to determine how parents of children with cancer rate a parent-delivered massage therapy educational program for usability and satisfaction, and if massage therapy, provided by parents to their child with cancer, reduce symptoms of anxiety and depression in the child, and parenting stress in the parent.

In Canadian children aged 0-19, the number of new cancer cases from 1997-2001 was on average 1,285 children per year for a total of 6,427 children over a five year period. Individual and family responses to a child's or adolescent's cancer diagnosis and treatment include psychological, sociocultural and biological dimensions. Parents of children with cancer can experience severe emotional distress including anxiety and depression. Parents require support and skills to reduce their own anxiety and distress and to help alleviate suffering in their children.

This is a two-phase research project: phase I: development of a standardized educational intervention on video/DVD to teach parents how to massage their child with cancer; phase II: test the feasibility of the developed intervention with children with cancer and their parents. A total of 24 parents and their children with cancer who are under the care of the paediatric oncology units at the Stollery Children's Hospital (Edmonton) will be recruited for the study.

It is hypothesized that this research on an educational program in parent-delivered massage therapy will directly improve the lives of children with cancer and their parents.

Parent-Delivered Massage in Paediatric Cancer

SickKids Foundation

Stollery Children's Hospital

Canadian Institute of Natural and Integrative Medicine

Centennial College

Trish Dryden, RMT, M.Ed, Director

Blood and Lymph Conditions

Hematologic Diseases

Review list of 25 cancer symptoms, 20-30 minute audio-taped personal interview and 15-20 minute questionnaire.

Interview

Tito Mendoza, PhD, MS, MED

The scientific aim of this study is to evaluate patient comprehension of the 77 newly developed items as well as the extent to which the items correspond to the concepts of interest for each patient reported outcome (PRO).

A secondary aim of this study is to evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system once it has been built to accommodate the learning garnered during the cognitive interviews.

Screening:

The study staff will talk to your doctor or nurse, and/or look at your medical record, to see if you are currently receiving treatment. The study staff will also look at your medical record to see if you have any future clinic visits at M. D. Anderson. This is the first step of "screening" to help the researchers decide if you are eligible to take part in this study.

If you are found to be possibly eligible to take part in this study based on the first step of screening, the second step of screening will occur:

At your clinic visit, the study staff will talk to you about this study. You will be asked questions about school, which should take about 2 minutes.

Study Visit If you are found to be eligible and you agree to take part in this study, you will look at a list of 34 cancer symptoms if you are a male or a list of 36 cancer symptoms if you are a female. You will fill out a questionnaire that asks you to mark each symptom that you may be experiencing at this time, and other information about the symptoms such as how often they occur.

After you complete the questionnaire, you will be interviewed by the study staff about how you answered some of the questions. For example, you will be asked if the words describing the symptoms were easy to understand or if other words may be more clear.

There are no right or wrong answers to any part of this study. Researchers are interested in your thoughts about the words.

Filling out the questionnaire will take about 10-15 minutes. The interview will take about 20-30 minutes.

Study Data:

The interview will be audio-recorded. Only the study staff will hear the recording. The recording will be saved on a password-protected computer that can only be accessed by the study staff.

Your responses will be coded without using your name or other personal identifying information. Only the study staff will have access to the code numbers and be able to identify you.

Your responses will not be shared with your doctor without your consent.

In some of the questions, you will be asked about your feelings (for example, whether you feel unhappy or anxious). If your responses show that you may be having emotional difficulties, you will be given a list of community agencies that provide services for emotional issues. You may also speak to your doctor about your feelings.

Length of Study:

After the study visit, your active participation will be over. In some cases, the study staff may call you to ask that you clarify some of your answers. Your medical record may also be checked to confirm the cancer diagnosis and your treatments.

This is an investigational study. Up to 100 patients will take part in this study. Up to 20 will be enrolled at M. D. Anderson.

Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing

Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing

The primary assessment tool will be the cognitive interview protocol.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Older Cancer Caregiver Needs Post Hospital Discharge	NCT02099526	Cancer Caregive...		18 Years -	Duke University
Parent-Delivered Massage in Paediatric Cancer	NCT00698113	Anxiety Depression Stress Pediatric Cance...	Massage Journaling	6 Years - 18 Years	Centennial College
Patient-Reported Outcomes Version of Common Terminology Criteria (CTCPRO) Cognitive Debriefing	NCT00909207	Advanced Cancer... Hematologic Dis... Solid Tumors	Interview	18 Years -	M.D. Anderson Cancer Center

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