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Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness to Patient With Terminal Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Terminal Illness

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Trial Information

Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness to Patient With Terminal Cancer


Inclusion and exclusion criteria:

This study is aimed at decreasing the decisional conflict among family members who are ready
or not to disclose patients' terminal illness. The decision aid will lead to effective
communication between patients and family and the effective decision making process will
lead to the final outcome to improve the quality of life in patients and their family. This
trial is limited to situations where the family and their patients are cognitively capable
of participating in decision-making process.

Measures:

Baseline Measures. At baseline, before randomization, self-reported questionnaire is used to
collect data. To correct possible confounders in this study, family' background variables
are assessed on entry to the study, including sociodemographic and decisional conflicts,
decisional-role preference, stage of readiness, level of anxiety and depression, and QOL.

Family decisional conflict is assessed using four subscales of the Decisional Conflict Scale
which assessed how well informed participants feel about their choices and the associated
benefits and risks; the clarity of their values; the support they have in the
decision-making process; and their level of uncertainty. It consists of 16 items followed by
a Likert response of 1, strongly agree, to 5, strongly disagree. A mean score is obtained
for each participant. The Decisional Conflict Scale (DCS) is translated into Korean by two
bilingual individuals, using a forward-backward translation procedure, and completed pilot
test.

Family preference for role in decision making is assessed using a scale modeled on an
instrument developed by Degner et al. We make family/patient dimension from modifying Degner
and Sloan's second Control Preference Scale set, family/physician dimension. The options of
modified set of five cards (family/patient dimension) range from the family making the
decision mainly, through a collaborative model where the family and patient jointly decided,
to a scenario where the patient made decision mainly. Family is asked to indicate whether
they preferred an independent role (i.e., "that the family makes the final decision
regarding which treatment the patient will receive or after considering patient's opinion"),
shared role (i.e., "that the family and patient together select which treatment is best for
the patient"), or a dependent role (i.e., "that the patient alone makes all the decisions
regarding the patient's treatment or considers the family's opinion"). Family participant
chose the decision-role statement that best described his/her preferred role in decision
making. The Control Preference Scale (CPS) is translated into Korean by two bilingual
individuals, using a forward-backward translation procedure, and completed pilot test.

Levels of family anxiety and depression is assessed by the Hospital Anxiety and Depression
Scale which consists of 14 items, seven on anxiety and seven on depression, forming two
sub-scales. Each item has four descriptive response options to be scored on a 0 to 3 scale.
A value of 0 corresponds to not having the symptom, 3 corresponds to having the symptom to a
high level. Scores for each of the two sub-scales are constructed by simple summation of its
seven items. The developers have suggested that sub-scale scores of 0-7 represent non-cases,
8-10 represent doubtful cases, and 11-21 represent definite cases.

The Baseline Patient's Generic QOL:. Because we expect the effect of intervention for family
to accompany change of patients' outcome, we measure patients' QOL and quality cancer care
at baseline to observe secondary outcome related with effect of the decision aid.

Patient's QOL is assessed with QCQ-EOL. To correct possible confounders in this study,
patient' background variables are obtained on entry to the study including sociodemographic
and medical records.

Outcome Measures:

The primary outcome to be considered is the potential efficacy of this aid including
family's decisional conflicts, satisfaction with decision making, and decisional-role
preference, decisional regret, and physician and family acceptance of the decision aid.

Family satisfaction with decision making is assessed using the effective decision-making
subscale of the decisional conflict instrument [O'Connor AM. Validation of a decisional
conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30]. The subscale was four items
regarding satisfaction with decision making (being informed, reflection of participant's own
values, likelihood to comply, and satisfied). Scores for family satisfaction are reversed so
that the higher scores reflect higher level of satisfaction (ie, a reversed Likert scale in
which 5 is the highest scored). A mean score is obtained for each patient.

Physician and participant's acceptance of the decision aid is addressed using two
questionnaires followed by a Likert response of 1, strongly agree, to 5, strongly disagree
(i.e., family assessment item, "The decision support was useful to me in reaching a
decision", "I would recommend that others facing the decision use the support", "The
decision support interfered with my relationship with patient", Physician assessment item,
"I feel the family has made an informed choice", "The decision support was useful in helping
this family understand the risk and benefits of the disclosure on terminal illness", "The
decision support did not interfere with my anticipated physician-patient relationship with
my patient")[Brundage et al2001]. Decision regret is measured by the Decision Regret Scale
which is useful tool for measuring regret after decisions at a particular point in time
developed by O'Connor et al. It consists of 5 items followed by a Likert response of 1,
strongly agree, to 5, strongly disagree. The definition of decision regret is remorse or
distress over a decision[O'Connor]. These items were whether regret was felt to be present,
whether the decision was the right one for him/her, whether he/she would make same decision
again in the same circumstances, whether the decision was a wise one, and whether the
decision had resulted in harm. The Decision Regret Scale is translated into Korean by two
bilingual individuals, using a forward-backward translation procedure, and completed pilot
test.

Secondary outcomes include the levels of family anxiety and depression,and family's QOL.

Levels of family anxiety and depression is assessed with the Hospital Anxiety Depression
Scale. The actual disclosure following use of the material is assessed by following items
including chosen disclosure and if terminal illness disclosed "who, and when disclose
patients' terminal condition" and it is assessed at 1, 3, and 6 months after sending the
material. Levels of family anxiety and depression, family decision regret, family preference
for role in decision making, and patient's QOL are assessed at 1, 3, and 6 months after
sending the video.


Inclusion Criteria:



Patient:

- age≥ 18years

- cancer patient

- terminally ill

- mentally competent

Family members:

- age≥ 18years

- having terminally ill cancer patients

- Spouse, daughter or son, parent, brother or sister

- having ability to understand the content of educational material

Exclusion Criteria:

- serious comorbidity(stroke, heart attack, acute or chronic respiratory, acute or
chronic renal disease, or cancer)

- inability to speak, hear or read Korean

- mentally incompetence (schizophrenia, bipolar, psychiatric or addictive disorder, or
severe emotional distress)

- Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Decisional conflict & satisfaction: Decisional Conflict Scale

Outcome Time Frame:

baseline, 1month, 3month, 6month

Safety Issue:

Yes

Principal Investigator

Young Ho Yun, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

nccncs-08-142

NCT ID:

NCT00686673

Start Date:

June 2008

Completion Date:

March 2009

Related Keywords:

  • Terminal Illness
  • DECISION AIDS

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