Measuring the concerns of cancer patients with low platelet counts: the Functional Assessment of Cancer Therapy–Thrombocytopenia (FACT-Th) questionnaire

Abstract

Purpose

The specific concerns of people with low platelet counts (thrombocytopenia) have not been characterized well in the literature and as a result proper measurement of patient-reported concerns is lacking. We report on the development and validation of questions specifically targeted to patients with thrombocytopenia that can be added to the more general concerns in the Functional Assessment of Cancer Therapy-General.

Materials and methods

An 18-item FACT-Thrombocytopenia Subscale (ThS) was rated and evaluated by thrombocytopenic patients at baseline during a validation study of 40 thrombocytopenic and 43 nonthrombocytopenic cancer patients. To evaluate responsiveness, patients completed a battery of self-report measures including the FACT-Th and were followed up for change in platelet count over 2 weeks.

Results

All subscales and aggregated scores showed high internal consistency at initial assessment and at retesting. Convergent and divergent validity were demonstrated by predicted relationships between FACT-Th subscales and mood, mental and physical component scores of the SF-36, and social desirability. The ThS differentiated patients with low platelets from those with normal platelet counts and good performance from poor performance status patients.

Conclusion

The FACT-Th is a reliable and valid measure for assessing the impact of thrombocytopenia on patients’ lives. It can distinguish cancer patients with and without thrombocytopenia and is responsive to increase in platelet count over time. The FACT-Th may therefore prove useful as a measure of self-reported symptoms and concerns related to thrombocytopenia in clinical trials evaluating new pharmacologic agents and/or platelet transfusion practice.

Appendix

FACT-Th^© additional concerns

Below is a list of statements that other people with your illness have said are important. By circling one (1) number per line, please indicate how true each statement has been for you during the past 7 days.

		Not at all	A little bit	Some-what	Quite a bit	Very much
An5	I have energy	0	1	2	3	4
An7	I am able to do my usual activities	0	1	2	3	4
Th1	I bleed easily	0	1	2	3	4
Th2	I bruise easily	0	1	2	3	4
Th3	I worry about problems with bruising or bleeding	0	1	2	3	4
Th5	I am bothered by nosebleeds	0	1	2	3	4
Th7	I am bothered by pinpoint bruising beneath my skin	0	1	2	3	4
Th8	I am bothered by blood in my urine or stool	0	1	2	3	4
Th10	I avoid or limit physical activity (because of concern with bleeding or bruising)	0	1	2	3	4
Th12	I am frustrated by not being able to do my usual activities	0	1	2	3	4
Th13	I worry that my treatment will be delayed (because of low blood counts)	0	1	2	3	4
The items below are excluded from the 11-item ThS
H7	I feel fatigued	0	1	2	3	4
Th4	I worry about the possibility of serious bleeding	0	1	2	3	4
Th6	I am bothered by bleeding in my gums or mouth	0	1	2	3	4
Th9	I am inconvenienced by platelet transfusions	0	1	2	3	4
Th11	I avoid or limit social activity (because of concern with bleeding or bruising)	0	1	2	3	4
Th14	I worry that my treatment dose will be reduced (because of low blood counts)	0	1	2	3	4
Th15	For women only: I am bothered by vaginal bleeding	0	1	2	3	4

1. ^© Copyright 2005, DAvid Cella, Ph.D