The Good Patient Study

Adolescents with cancer weigh multiple influences in medical decision-making, including their own best interest, the perceived wishes of family members, and the interpreted preferences of the health care team. Parents of children with cancer often describe themselves as trying to be a good parent in making decisions in the child's best interest. Adolescents with cancer often describe themselves as trying to be a good patient and good child in making decisions in accord with how they believe a good patient and good child would decide.

Among the challenges of caring for adolescents is the reality that the formative relational influences in adolescents' decision-making are both complex and unique due to adolescent patients' social networks and relational roles. Delineating adolescents' definitions of being a good patient, a good child, a good sibling, and a good friend may enable the care team to better understand the formative decisional influences relevant to adolescents with cancer. Expanding knowledge about the decision making constructs relevant to adolescents with cancer and recognizing the role of these social constructs in medical interactions has the potential for development of a comprehensive care model that methodically evaluates the self-assessed decision making influences and needs of adolescents at various stages in oncology care.

This qualitative construct-defining study represents an initial step in the development of enhanced interventions for improved psychosocial support in this vulnerable population.

Study Overview

• Status: Completed
• Conditions: Solid Tumor; Brain Tumor; Hematological Malignancies
• Intervention / Treatment: Other: Interview

Detailed Description

PRIMARY OBJECTIVES:

• Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions;
• By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making;
• Identify adolescent participants' preferred role in medical decision making.

SECONDARY OBJECTIVES:

• Develop definitions of being a "good" patient, child, sibling, and friend from adolescent participant reports (will also welcome the study participant to self-declare any additional relational constructs they may wish to report);
• Describe how the adolescent study participant believes his or her "good" patient, child, sibling, and friend definition may have changed over time;
• Describe the self-assessed positive and negative aspects of trying to achieve the meanings of the "good" patient, child, sibling, and friend constructs from adolescent participant reports;
• Describe the actions of members of the study participant's social network which may help the study participant reach his/her definition of being a "good" patient, child, sibling, and friend.

Participants will participate in a one-time voice-recorded, face-to-face interview consisting of open-ended questions. Completion of the interview is expected to take less than one hour.

The qualitative interview consists of thirty open-ended questions for participants with no siblings and thirty-eight open-ended questions for participants who have siblings. Questions will be audio-recorded, face-to-face semi-structured in-depth interview format. Health information will also be collected from medical records.

Expected accrual is 100 participants, 50 at each participating site. Accrual will be halted when the study reaches qualitative theme saturation. For this study, saturation will occur when three consecutive interviews fail to raise a new theme.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Health System
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be teens who are patients at St. Jude Children's Research Hospital and meet the criteria for study enrollment.

Description

Inclusion Criteria:

• Participants must be between 12 and 19 years of age at the time of enrollment.
• Participants must have primary care team approval to participate.
• Participants must be English-speaking.
• Participants must carry an oncologic diagnosis.
• Participants must be within four months of initial oncologic diagnosis or within four months of relapse/recurrent disease.

Exclusion Criteria:

• This study lacks any exclusion related to pregnancy (an Institutional Review Board requirement for enrollment of females who are capable of becoming pregnant), lactation or plans to become pregnant and lacks any exclusion of males fathering children while on study.
• Patients who, in the opinion of their physician, are not capable mentally or verbally of participating in the interview, will be excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Participants; All enrolled participants will take part in a face-to-face interview.	Other: Interview; This study involves teen participants taking part in one private interview with the study team. Interviews last less than one hour and are scheduled at the participant's convenience. Interviews will be audio/digital recorded. Participants may answer any or all of the questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors contributing to decision-making	Describe the ways relationships and social interactions may factor into adolescent study participants' approach to decisions.	Once, at enrollment
Behaviors that make a positive impact on decision-making	By reports from adolescents with cancer, identify behaviors from members of the study participants' social network that would be helpful to adolescents in fulfilling their preferred role in medical decision-making and achieving the desired level of participation in medical decision-making.	Once, at enrollment
Preferred decision-making role	Identify adolescent participants' preferred role in medical decision making.	Once, at enrollment

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Meaghann Weaver, MD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (ESTIMATE): July 24, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 4, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Adolescent; Decision-making; Social network
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: GPS14