Preliminary Results of the Generation of a Shortened Quality-of-Life Assessment for Patients with Advanced Cancer: The FACIT-Pal-14

Abstract

Objective:

Shortened quality-of-life (QOL) tools are advantageous in palliative care patients. Development of such tools begins with the identification of issues relevant to a population. The purpose of this study was to identify the most important items of the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) to create an abbreviated questionnaire for future palliative care trials.

Methods:

A convenience sample of patients and health care professionals (HCPs) assessed the relevance of each item of the FACIT-Pal and whether they would include the item in a final questionnaire. Patients and HCPs identified their top 10 most important issues and were asked whether items were inappropriate, upsetting, or irrelevant; a shortened questionnaire was generated from this input.

Results:

Sixty patients and 56 HCPs participated. The median score in the Karnofsky Performance Scale (KPS) of patients was 70, and the majority of HCPs were radiation oncologists. The 46-item questionnaire was shortened to 14 questions, retaining several items from the Functional Assessment of Cancer Therapy-General (FACT-G) as well as issues pertaining specifically to palliative care patients. Items within the emotional, physical, and functional well-being subscales were retained along with those for various symptoms including constipation, nausea, dyspnea, and sleep. No new content beyond what is covered by the FACIT-Pal was identified consistently by either HCPs or patients. Similarly, no item was consistently rated as being inappropriate, upsetting, or irrelevant in the 14-item questionnaire.

Conclusion:

The FACIT-Pal-14, a shortened 14-item questionnaire has been generated for the palliative care population. Future studies should complete psychometric validation of this instrument for the assessment of QOL in palliative care patients.

Introduction

Quality of life (QOL) is an important endpoint in palliative care research as traditional markers of treatment efficacy such as survival and disease-free progression are no longer appropriate. Patients at an advanced stage of cancer are often polysymptomatic and treatment goals change to management of symptoms and improvement or maintenance of quality of life, rather than extension of survival.

Validated instruments containing issues relevant to patients rated on Likert scales are commonly used to assess QOL. In the general cancer population, the European Organization for Research and Treatment of Cancer (EORTC) and Functional Assessment of Cancer Therapy (FACT) groups both offer tools for the evaluation of general health-related QOL issues, the EORTC QLQ-C30¹ and the FACT-General (FACT-G),² respectively. They are most commonly used in the measurement of QOL in cancer; however, there is no similar consensus regarding the measurement of QOL specific to the palliative care setting.

The Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) was developed as a 19-item subscale to supplement the core 27-item FACT-G measure with issues relevant to patients in palliative care (46 items in total).^3,4 The reliability and validity of the questionnaire was established in a sample of 256 patients with advanced cancer,³ after earlier work identified important issues.⁴ The palliative subscale is scored as a whole, in addition to physical well-being, social/family well-being, emotional well-being, and functional well-being domains as assessed by the FACT-G.

There are two major considerations when developing an instrument for use in palliative care. First, the topics covered must be relevant, appropriate, and offer coverage of the most important issues in this population. Domains or items covered by the QLQ-C30 or the FACT-G may not be appropriate or relevant in this population. Second, especially in patients with advanced disease or lower performance status, shorter instruments are beneficial, as it reduces patient burden, especially when obtaining longitudinal data.⁵ Furthermore, condensed tools may improve accrual and decrease attrition, which have been consistently cited as being barriers in palliative care research.⁶ It has been shown that shorter tools improve compliance and to patients themselves, there is preference toward such instruments.⁷

The EORTC QLQ-C30 core questionnaire was shortened to produce a 15-item questionnaire (QLQ-C15-PAL).⁸ There are little published data available on this abbreviated core questionnaire. The FACIT-Pal is a 46-item questionnaire (FACT-G plus a palliative subscale) that was developed to extend the content validity of the FACT-G in the palliative care setting; however, a shortened version is not yet available. Handling of social health in the EORTC and FACT approaches differs in that the former focuses on social function and the latter on social relationships and support,⁹ things that increase in importance in the palliative care setting. Additional, validated shortened tools for use in the palliative care setting may allow investigators to choose instruments based in individual study needs. The purpose of this study was to shorten the FACIT-Pal to a length that would be more amenable to the palliative care population, without compromising its core content validity.

Methods

A convenience sample of patients with advanced cancer and health-care professionals (HCPs) involved in their care at Sunnybrook Health Sciences Centre, Toronto, Canada, evaluated all items of the FACIT-Pal on relevance and relative importance. Patients were included if they were well enough to complete the questionnaire (adequate performance status; i.e., of at least KPS score ≥30) as well as spoke/read English. Shortening of the FACIT-Pal were based on methodology adapted from the EORTC guidelines on tool development.¹⁰ Briefly, items must be relevant, have breadth of coverage, and the relative importance of issues must be identifiable. Both patients and HCPs completed three tasks: 1) for each individual item, participants rated the item from a scale of 0 “not at all relevant” to 4 “very relevant”; 2) were asked whether each item should be included in the final questionnaire (yes/no); and 3) ranked the top 10 most relevant and important issues. Patients were asked to consider the relevance and importance of each item to their current treatment and care, whereas HCPs were asked to answer based on their experience with palliative care patients in general, not focusing on specific cases. The percentage of patients and HCPs selecting an item to as a top 10 issue was averaged to create a mean percentage.

Patient demographics were summarized by mean, standard deviation (SD), median, quartiles, and ranges for age and KPS; proportions for gender, primary cancer site, clinic, and patient status. HCP demographics were also summarized by years of professional experience, gender, and profession. An open-ended debriefing question followed that asked participants whether any items were inappropriate, irrelevant, or upsetting. Descriptive statistics summarized findings. Patient and HCP responses to relevance and the top issues were compared to formulate a shortened questionnaire. If >25% of both patients and HCPs identified an item as being a top issue, it was included directly into the final questionnaire. In cases where this requirement was not satisfied, further consideration was made based on other responses and experience. This study was approved by the Hospital Research Ethics Board and all patients signed consent. All analyses were conducted using SAS version 9.2 for Windows (SAS Institute Inc., Cary, NC).

Results

Participant demographics

The FACIT-Pal (Table 1) was presented to a total of 60 patients (Table 2) and 56 HCPs who participated in this study (Table 3). Mean age of patients was 65.6 years, and the majority of patient participants were male (62%). Primary cancers of the prostate (33%), breast (18%), and lung (11.7%) were most common. Most patients had metastases to the bone (50%), were enrolled from a radiation oncology clinic (60%), and were outpatients (77%). HCPs included in this analysis had on average 7.0 years experience in their current field. The majority were radiation oncologists (43%), followed by radiation therapists (18%) and nurses (11%); genders were balanced (male: 53%).

Table 1.

Items Included in the FACIT-Pal and Their Item Codes

Physical well-being	GP1	I have a lack of energy
	GP2	I have nausea
	GP3	Because of my physical condition, I have trouble meeting the needs of my family
	GP4	I have pain
	GP5	I am bothered by side effects of treatment
	GP6	I feel ill
	GP7	I am forced to spend time in bed
Social/Family well-being	GS1	I feel close to my friends
	GS2	I get emotional support from my family
	GS3	I get support from my friends
	GS4	My family has accepted my illness
	GS5	I am satisfied with family communication about my illness
	GS6	I feel close to my partner (or the person who is my main support)
	GS7	I am satisfied with my sex life
Emotional well-being	GE1	I feel sad
	GE2	I am satisfied with how I am coping with my illness
	GE3	I am losing hope in the fight against my illness
	GE4	I feel nervous
	GE5	I worry about dying
	GE6	I worry that my condition will get worse
Functional well-being	GF1	I am able to work (include work at home)
	GF2	My work (include work at home) is fulfilling
	GF3	I am able to enjoy life
	GF4	I have accepted my illness
	GF5	I am sleeping well
	GF6	I am enjoying the things I usually do for fun
	GF7	I am content with the quality of my life right now
Additional concerns (19-item palliative subscale)	PAL1	I maintain contact with my friends
	PAL2	I have family members who will take on my responsibilities
	PAL3	I feel that my family appreciates me
	PAL4	I feel like a burden to my family
	B1	I have been short of breath
	PAL5	I am constipated
	C2	I am losing weight
	O2	I have been vomiting
	PAL6	I have swelling in parts of my body
	PAL7	My mouth and throat are dry
	Br7	I feel independent
	PAL8	I feel useful
	PAL9	I make each day count
	PAL10	I have peace of mind
	Sp21	I feel hopeful
	PAL12	I am able to make decisions
	L1	My thinking is clear
	PAL13	I have been able to reconcile (make peace) with other people
	PAL14	I am able to openly discuss my concerns with the people closest to me

Table 2.

Patient (n=60) Demographics

Age (years)
N	60
Mean±SD	65.6±13.0
1^st–3^rd quartiles	56–76
Median (range)	68 (38–88)
KPS
N	58
Mean±SD	67.6±17.8
1^st–3^rd quartiles	50–80
Median (range)	70 (30–100)
Gender
Male	37 (62%)
Female	23 (38%)
Primary cancer site
Prostate	20 (33%)
Breast	11 (18%)
Lung	7 (12%)
Renal cell	5 (8%)
Oesophagus	3 (5%)
Colorectal	2 (3%)
Unknown	2 (3%)
Others	10 (17%)
Clinic
Radiation oncology	36 (60%)
Medical oncology	3 (5%)
Palliative care unit	9 (15%)
Others	12 (20%)
Patient status
Outpatient	46 (77%)
Inpatient	14 (23%)

KPS, Karnofsky Performance Scale; SD, standard deviation.

Table 3.

Health Care Professional (n=56) Demographics

Years of professional experience
N	56
Mean±SD	7.0±6.0
1^st–3^rd quartiles	2–10
Median (range)	6 (1–25)
Gender
Male	31 (55%)
Female	25 (45%)
Profession
Radiation oncologist	24 (43%)
Radiation therapist	10 (18%)
Nurse	6 (11%)
General practitioner in oncology	2 (4%)
Palliative care physician	2 (4%)
Medical oncologist/Hematologist	1 (2%)
Others	11 (20%)

SD, standard deviation.

Items to be included on final questionnaire

Greater than 50% of patients rated all items on the FACIT-Pal as ones that should be included in the final questionnaire (Table 4). Regardless of the subscale, all items were consistently recommended to be included. The highest rated item, “I get emotional support from my family,” was rated by 55/60 (92%) of patients to be in the final questionnaire. An optional question on sexual satisfaction, in which approximately half of patients (34/60) felt comfortable answering, was recommended by only 18/34 (53%) of patients to be included. Appendices 1 and 2 list degrees of relevance in patients and HCPs. (Appendices 1 and 2 are available at www.liebertpub.com/jpm)

Table 4.

Patient and HCP Responses on Whether Items Should Be Included in the Final Questionnaire

Domain/Item	Patient responses		HCP responses
	n/N	%	n/N^a	%
Physical well-being
GP1	52/60	87%	31/37	84%
GP2	47/60	78%	31/37	84%
GP3	42/60	70%	20/37	54%
GP4	51/60	85%	34/37	92%
GP5	48/58	83%	23/37	62%
GP6	40/59	68%	10/37	27%
GP7	41/59	69%	23/37	62%
Social/family well-being
GS1	36/60	60%	6/37	16%
GS2	55/60	92%	18/37	49%
GS3	43/60	72%	15/37	41%
GS4	48/60	80%	15/37	41%
GS5	48/59	81%	19/37	51%
GS6	48/59	81%	17/37	46%
GS7	18/34	53%	13/37	35%
Emotional well-being
GE1	47/60	78%	28/37	76%
GE2	49/59	83%	27/37	73%
GE3	42/58	72%	19/37	51%
GE4	35/60	58%	14/37	38%
GE5	41/59	69%	30/37	81%
GE6	47/59	80%	27/37	73%
Functional well-being
GF1	43/60	72%	19/37	51%
GF2	39/60	65%	11/37	30%
GF3	50/60	83%	28/37	76%
GF4	50/58	86%	23/37	62%
GF5	48/60	80%	29/37	78%
GF6	46/59	78%	19/37	51%
GF7	44/60	73%	29/37	78%
Additional concerns
B1	38/59	64%	32/37	86%
BR7	42/59	71%	25/37	68%
C2	46/59	78%	23/37	62%
L1	44/59	75%	18/37	49%
O2	41/56	73%	28/37	76%
PAL1	42/60	70%	12/37	32%
PAL10	43/59	73%	18/37	49%
PAL12	49/59	83%	23/37	62%
PAL13	36/56	64%	10/37	27%
PAL14	53/59	90%	22/37	59%
PAL2	53/60	88%	14/37	38%
PAL3	48/60	80%	8/37	22%
PAL4	41/58	71%	23/37	62%
PAL5	44/59	75%	26/37	70%
PAL6	38/59	64%	17/37	46%
PAL7	44/59	75%	19/37	51%
PAL8	36/58	62%	14/37	38%
PAL9	45/59	76%	11/37	30%
SP21	45/58	78%	14/37	38%

Among 56 health care professionals (HCPs), 37 HCPs responded whether the item should be included in the final questionnaire.

n=number of patients or HCPs who responded that the item should be included in the final questionnaire; N=total number of patients or HCPs with available responses on the questionnaire.

Item codes can be found in Table 1.

Rating of whether individual items should be included was much more variable among HCP respondents. Questions within the physical and functional well-being domains were selected on average more than items on social/family and emotional well-being. Within domains, there was also variation in the selection of items. For example, in the functional well-being scale, “I have pain” was rated by 34/37 respondents to be included, whereas “I feel ill” was rated for inclusion by only 10/37.

Issues considered when formulating the shortened questionnaire

We were aware of a parallel project to shorten the 27-item FACT-G to 7 items.¹¹ Four of these items had been identified as a top 10 issue by both patients and HCPs, and the remaining three were within the top 20 items, rated by >25% of at least one group. To retain comparability across short forms, and because of the high ratings of all 7 items, they were all retained in the shortened questionnaire.

After establishing this 7-item base, all other items that were rated by >25% of patients as being a top issue were included in the final questionnaire (Tables 5, 6). Of these 6 items, 4 were rated by ≥25% of both patients and HCPs, and the remaining 2 only by patients. Shortness of breath was rated as a top 10 issue by only 9% of patients, whereas 51% of HCPs identified it as being so. This may be a result of our sampling, as only 12% of patients had a primary lung cancer, and the majority were seen for bone metastases; or it may be due to the fact that not many patients were experiencing or had experienced this symptom at that time. This may be highlighted best by the fact that 47% of patients felt that shortness of breath was “not at all” relevant. For these reasons and the fact that this item was the third highest rated by HCPs, it was decided that it should be included, bringing the total number of items to 14 (initial 7-item FACT-G core+6 rated as a top issue by ≥25% of patients+1 on dyspnea due to clinical demand).

Table 5.

Percentage of Patients and HCPs Rating as a Top 10 Item

		Patients' responses (N=44)		HCPs' responses (N=41)
Order	Item	n	%	n	%	Mean % of selecting item as Top 10
1	GP4	17	39%	30	73%	56%
2	GP1	14	32%	26	63%	48%
3	GP2	8	18%	21	51%	35%
4	GE5	10	23%	19	46%	35%
5	GE1	11	25%	18	44%	34%
6	GS2	18	41%	11	27%	34%
7	GF7	11	25%	16	39%	32%
8	PAL4	11	25%	16	39%	32%
9	B1	4	9%	21	51%	30%
10	GE2	9	20%	16	39%	30%
11	GP5	9	20%	14	34%	27%
12	PAL5	11	25%	12	29%	27%
13	GE6	12	27%	9	22%	25%
14	GF3	13	30%	8	20%	25%
15	O2	5	11%	15	37%	24%
16	GF5	6	14%	14	34%	24%
17	PAL14	11	25%	9	22%	23%
18	BR7	7	16%	12	29%	23%
19	GP7	9	20%	10	24%	22%
20	GF4	10	23%	8	20%	21%
21	PAL10	10	23%	8	20%	21%
22	PAL12	7	16%	10	24%	20%
23	L1	0	0%	8	19%	20%
24	C2	9	20%	7	17%	19%
25	GP3	7	16%	7	17%	16%
26	GS6	8	18%	5	12%	15%
27	PAL2	10	23%	3	7%	15%
28	SP21	12	27%	1	2%	15%
29	GS3	6	14%	6	15%	14%
30	GS4	6	14%	6	15%	14%
31	GP6	6	14%	4	10%	12%
32	PAL7	6	14%	4	10%	12%
33	PAL8	7	16%	3	7%	12%
34	PAL1	5	11%	0	0%	11%
35	PAL3	5	11%	0	0%	11%
36	GE4	6	14%	3	7%	10%
37	GF6	6	13%	3	7%	10%
38	GS5	4	9%	3	7%	8%
39	PAL13	4	9%	3	7%	8%
40	GE3	5	11%	2	5%	8%
41	GS7	0	0%	3	7%	7%
42	PAL9	4	9%	2	5%	7%
43	GS1	5	11%	1	2%	7%
44	GF1	3	7%	2	5%	6%
45	PAL6	3	7%	2	5%	6%
46	GF2	1	2%	2	5%	4%

n=number of patients or health care professionals (HCPs) who rated the item as one of the top 10; N=total number of patients or HCPs with available responses on the questionnaire.

Bolded codes indicate inclusion into the final shortened palliative questionnaire; item codes can be found in Table 1.

Table 6.

Final 14-item Questionnaire: The FACIT-Pal-14

				Inclusion as a result of …
Item Code	Item	% of pts listing as top 10	% of HCPs listing as top 10	Part of shortened FACT-G	Rated in top 10 by > 25% pts	Rated in top 10 by > 25% HCPs
GP1	I have a lack of energy	32%	63%	✓
GP2	I have nausea	18%	51%	✓
GP4	I have pain	39%	73%	✓
GE6	I worry that my condition will get worse	27%	22%	✓
GF3	I am able to enjoy life	30%	20%	✓
GF5	I am sleeping well	14%	34%	✓
GF7	I am content with the quality of my life right now	25%	39%	✓
GS2	I get emotional support from my family	41%	27%		✓	✓
SP21	I feel hopeful	27%	2%		✓
GE1	I feel sad	25%	44%		✓	✓
PAL4	I feel like a burden to my family	25%	39%		✓	✓
PAL5	I am constipated	25%	29%		✓	✓
PAL14	I am able to openly discuss my concerns with the people closest to me	25%	22%		✓
B1	I have been short of breath	9%	51%			✓

HCPs, health care professionals.

One item (“I worry about dying”) was rated as being important by both patients and HCPs but was not included because the less-direct “I worry my condition will get worse” was included, and because it can more likely lead to missing response data.⁹

Debriefing questionnaire

Three patients felt that “I have been able to reconcile (make peace) with other people” was irrelevant and not applicable to their illness. No other item was consistently rated as being upsetting or inappropriate by patients. When debriefing HCPs, no item was consistently rated as being upsetting or inappropriate. The final questionnaire, the FACIT-Pal-14, including the reasons for individual item selection, can be seen in Table 6.

Discussion

Brief QOL assessments are beneficial for palliative care patients as they decrease burden and improve compliance. Generation of content with input from patients and their health care providers is the first step in the development of a QOL assessment tool. The FACIT-Pal includes the commonly used FACT-G along with a palliative care subscale, and allows for evaluation of QOL issues relevant to patients with advanced cancers or in palliative care. Based on patient and health care professional input on the relevance of each question, we have shortened the 46-item questionnaire to 14 items. No further issues are consistently (i.e., frequently) identified by patients or HCPs to be missing from this shortened questionnaire.

Previously, EORTC had developed an abbreviated version of the commonly used QLQ-C30 for the palliative care population, the QLQ-C15-PAL.⁸ Studies that have compared the use of the QLQ-C30 and QLQ-C15-PAL, have commented that practicability and compliance were better with shortened tools.^5,7 Until now, a shortened version of the FACT-G did not exist, which limited the selection of appropriate palliative care instruments available to investigators. Content assessed by the QLQ-C15-PAL and FACIT-Pal-14 are similar, especially in symptoms assessed as both ask patients about shortness of breath, pain, insomnia, nausea, constipation, and fatigue. Differences are observed in functioning, where the QLQ-C15-Pal asks about walking ability, assistance with daily activities, and pain interference. The FACIT-Pal-14 includes more items on social/family and emotional well-being and also includes a question on global QOL. Selection between the two instruments after validation of the FACIT-Pal-14 will ultimately be dependent on study goals.

Both items deemed for inclusion based on patient response alone (“I feel hopeful” and “I am able to openly discuss my concerns with the people closest to me”) pertained to the psychosocial aspects of care, and in general, these items were rated higher in relative importance by patients. The discordance of rating the importance of psychosocial issues between patients and HCPs has been documented previously¹² and was suggested to be possibly due to the fact that professionals tend to be concerned with issues that they could directly manage. Because the majority of our sample of HCPs included members of radiation oncology teams, they may have been more concerned with issues more commonly managed in their setting.

We acknowledge that limitations exist; however, this is the first step in generating a shortened instrument for use in the palliative care population. We are primarily limited in our sampling, as all patients and HCPs were English speakers and were enrolled from a single center in Canada, as a convenience sample. Including additional countries in future validation studies may reveal how cross-cultural factors influence patients' QOL and other issues that may be of great relevance. Similarly, the majority of patients and HCPs were enrolled in the radiation oncology setting, and we may overrepresent issues common to these patients, especially as the majority of patients had bone metastases. In addition, we did not collect data on the proportion of patients approached for study that consented, which may cause the sample to not be fully representative of the patient population as a whole. The median KPS score in our sample was 70, which may not be representative of patients of lower performance status. Doctors are highly represented in the sample and therefore may have skewed our findings. Lastly, as shortening was completed after patient interviews, we were unable to present the final FACIT-Pal-14 to patients and ask if any issues were relevant but not included. We recommend future validation studies to include these questions.

This shortened version of the FACIT-Pal remains in the early stages of development, and psychometric validation is required before it can be used as an assessment tool.

Conclusion

Identification of important issues is the first step in developing a QOL tool. Based on patient and health care professional responses, a 14-item palliative QOL instrument is proposed. The FACIT-Pal-14 includes items on physical, emotional, social/family, and functional well-being and symptoms stated to be important by this population. With future psychometric validation, it is intended for the FACIT-Pal-14 to act as a core instrument for palliative care outcome research.

Footnotes

Acknowledgments

We thank the generous support of the Bratty Family Fund, Michael and Karyn Goldstein Cancer Research Fund, Joseph and Silvana Melara Cancer Research Fund, and Ofelia Cancer Research Fund. We would also like to thank all the survey participants for their helpful input.

Author Disclosure Statement

No competing financial interests exist.

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